Product was distributed in Ohio and Indiana.
True Energy Formula A - Bulk - No labeling, all products in tanker trucks
Feed raw material was manufactured using oil that was contaminated with Lascadoil.
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
725-55 HEN TURKEY BREEDER DIET. The product is made and transported in bulk.
Contaminated oil was used as a raw material to make finished animal feed.
Swine feed Ration #407. The product is made and transported in bulk.
725 HEN TURKEY BREEDER DIET 102. The product is made and transported in bulk.
Swine feed Ration #3407. The product is made and transported in bulk.
906 TURKEY BREEDER HOLDING 1. The product is made and transported in bulk.
902 TURKEY BREEDER REPLACEMENT 2 w/ HISTOSTAT. The product is made and transported in bulk.
905 TURKEY BREEDER REPLACEMENT 5 w/AVATEC. The product is made and transported in bulk.
830 10% TOM BREEDER + Methionine (Experimental). The product is made and transported in bulk.
903 TURKEY BREEDER REPLACEMENT 3 w/ HISTOSTAT. The product is made and transported in bulk.
Swine feed Ration #31007. The product is made and transported in bulk.
The affected product was distributed to Ohio and Pennsylvania.
All Livestock, Poultry, and Deer feeds, medicated and non-medicated, which were manufactured using the contaminated lascadoil. The product is made and transported in bulk with no labeling.
Contaminated ingredient oil [TEFA] from supplier was used as an ingredient in animal feeds.
The firm does not assign batch or lot codes to the products.
The affected product was distributed in Ohio and Alabama. There are no foreign conosignees or government consignees.
Custom horse feeds packaged in 50 lb. bags, 100 lb. bags, and in bulk
Animal feeds were manufactured with an ingredient that had been manufactured with contaminated oil.
The firm does not assign lot or batch codes to product.
Custom deer feed packaged in 50 lb. bags, 100 lb. bags, and in bulk
Horse Feed packaged in 50 lb. bags, 100 lb. bags, and in bulk
Calf Grower with Bovatec packaged in 50 lb. bags, 100 lb. bags, and in bulk
LM Calf Grower packaged in 50 lb. bags, 100 lb. bags, and in bulk
Rumensin Calf Grower packaged in 50 lb. bags, 100 lb. bags, and in bulk
18% Calf Starter packaged in 50 lb. bags, 100 lb. bags, and in bulk
26% Calf Pellets packaged in 50 lb. bags, 100 lb. bags, and in bulk
32% Calf Supplement Pellet packaged in 50 lb. bags, 100 lb. bags, and in bulk
Custom cattle feeds packaged in 50 lb. bags, 100 lb. bags, and in bulk
12% Beef Grain packaged in 50 lb. bags, 100 lb. bags, and in bulk
Premium Deer Feed packaged in 50 lb. bags, 100 lb. bags, and in bulk
Worldwide Distribution - US to AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WY + District of Columbia + Guam; Internationally to Australia, Bahrain, Bangladesh, Cambodia, Canada, China, Germany, Hong Kong, India, Indonesia, Malaysia, Maldives, Mongolia, Mynamar, Nepal, New Zealand, Pakistan, Philippines, Singapore, South Korea, Sri Lanka, Taiwan, Thailand, and Vietnam.    THE CORRECTION IS LIMITED TO XN-10/XN-20 UNITS DISTRIBUTED BY SYSMEX AMERICA, INC., INSTALLED AT END-USER SITES IN US, PUERTO RICO, AND CANADA.
The XN-Series modules (XN-10, XN-20) are quantitative multi-parameter automated hematology analyzers intended for in vitro diagnostic use in screening patient populations found in clinical laboratories.
1,137 units (US) 54 units (Canada) 9 inventory
There is a potential for elevated hemoglobin (Hgb) and impedance platelet count (PLT-I) values.
The affected products were distributed inside the state of Ohio.
Fifty pound bags and bulk shipment of 12% Hi Oats Horse Feed
Feed was manufactured with an ingredient that had been manufactured with contaminated oil.  The oil was a non-food use oil that was blended into a feed grade oil by the oil supplier.
Fifty pound bags and bulk shipment of 17% Deer Feed
Fifty pound bags and bulk shipment of 10% Horse Feed
Fifty pound bags and bulk shipment of 11% Beef Feed
The affected product was distributed to the following states:  OH, PA, AR, and NY.
Various custom livestock feeds, packaged in 50 lb. paper bags and in bulk
Feed was manufactured with an ingredient that had been manufactured with contaminated oil.
Valeant Pharmaceuticals North America LLC
Chlordiazepoxide HCl/Clidinium Bromide capsules, 5 /2.5 mg, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada;  Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ  08807, NDC 68682-409-10.
Librax (5 mg chlordiazepoxide HCl and 2.5 mg clidinium bromide) capsules, 100-count bottle, Rx Only, Manufactured in Canada by: Valeant Pharmaceuticals International, Inc., Steinbach, MB R5G 1Z7 Canada;  Manufactured for: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, NDC 0187-4100-10.
EVARREST Fibrin Sealant Patch, Manufactured by: Omrix Biopharmaceuticals, Ltd, Israel.    Indicated for use with manual compression as an adjunct to hemostasis for control of bleeding during adult liver surgery and soft tissue bleeding in adults when control of bleeding by standard surgical methods of hemostasis is ineffective or impractical.
were printed in the expiration date field on the foil pouch labels of the Fibrin Patch units instead of the valid expiration date (2016-12-28).
Syfrett Horse Pellets, also known as Syfrett All Purpose Pellets, a non-medicated pellet feed. Item # 4-1200 (This feed was not bagged but was sent to a customer tank where individuals can drive up and fill their bulk bins or bags with the feed.)
Customer complaints that the feed was causing horses to fall ill or die
The product was distributed in Maryland to two Direct accounts and one Distributor
Chicken and Vegetable, K-9, Dog Food, Frozen Raw Dog Food Patties.
Chicken and Vegetable, K-9, Dog Food (sample  # 912272 ) tested positive for Listeria monocytogenes and Salmonella.    Chicken and Vegetable, K-9, Dog Food is manufactured by the Boesl Packing Company, Inc., 2322 Belair Rd, Baltimore, Maryland.
Sold in Bulk truck  Southern States  SSC-25-249707  Commercial   28% Gamebird Starter   Lot G5252    Per customer request: feed contains added Amprolium 1.4 lbs/ton (159g/Ton)
Particle size for Commercial 28% Gamebird Starter was larger than intended resulting in starve out of quail.
Nationwide distribution to AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KY, MO, MS, NC, NY, OH, OK, PA, SC, TX, UT, VA, and WA.  There was not foreign, government, or military distribution.
Good 'n' Fun Beefhide Chicken Sticks Chicken Jerky, Item No. 82247, packaged in cases of 24 bags.  Each bag contains 10 sticks - Net Wt. 2.8 oz. (80g), UPC 0 91093 82247 1.  Made in Colombia.  Distributed by Salix Animal Health, LLC, Deerfield, FL 33442.
Product may be contaminated with Salmonella.
Ducktrap Smoked Mussels in both 6oz and 16oz Tubs
Environmental sampling detected Listeria in the environment.
Lot Numbers: 533006 to 538003    Explanation of coding:  The lot # coding is (538003 for example)  - 5  year (2015), 38 week, 00 batch during the day if more than one batch produced, 3 day of the week, 1 is Sunday so 3 would be Tuesday.
Ducktrap Smoked Scallops in both 6oz and 16oz Tubs
Lot Numbers: 535003 to 538004.    Explanation of coding:  The lot # coding is (538003 for example)  - 5  year (2015), 38 week, 00 batch during the day if more than one batch produced, 3 day of the week, 1 is Sunday so 3 would be Tuesday.
Ducktrap Smoked Shrimp in both 6oz and 16oz Tubs
Dakota Calf Starter 22% R40, Medicated, Type C Medicated Feed.  Product code RHRJ.  Complete feed for dairy starter - 3 days to 3 mons in confinement.  For Prevention and control of coccidiosis due to Eimeria bovis and Eimeria zuemii.  Monensin (as Monensin Sodium) 40.00 g/ton.  Manufactured by Purina Animal Nutrition LLC, 1080 County Road F West, Shoreview, MN  55126-2910. Bulk Net Weight.
The Dakota Calf Starter 22% R40 has an elevated level of Monensin.  This may have resulted in calf mortality.
11/10/2015; manufacturing date and lot number are the same
PetSmart Stores in:  California, Nevada, Utah, Kansas, Washington, Montana, Minnesota, Oregon, Michigan
Blue Wilderness Wild Chews - Cub Size Wilderness Wild Chews Bones, UPC: 840243110087
1440 bones were shipped to two PetSmart distribution centers, 240 bones were shipped to PetSmart stores. 11 bones were sold to customers
Cub Size Wilderness Wild Chews Bones may be contaminated with Salmonella.
AZ, CA, CO.IL, MN, MD, OR, PA, SC, TX, WA
Bravo All Natural  Chicken  Blend diet for dogs & cats. 2lb (32 oz) chubS   Item Number: 21-102  UPC: 829546211028
Worldwide Distributed - US Nationwide in the US including American Samoa, Guam Puerto Rico and in the following countries:    Argentina, Australia, Austria, Bangladesh, Belgium, Bermuda, Bolivia, Brunei Darussalam, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jordan, , Kenya, , Kuwait, Latvia, Lithuania, Malaysia, Moldova Republic of, Morocco, Namibia, Netherlands, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia (Slovak Republic), Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Viet Nam, Virgin Islands (British), and Yemen.
Natus neoBLUE Phototherapy system, Catalogue Part Number: 010066.  Top Assembly Part Numbers: 001103, 001314, 002110, 040906, 040904, 040756, 040758, 040658, 040680.    Product Usage:  Used to provide treatment for neonatal hyperbilirubinemia
13541 units total (7840 units in the US and 5701 units outside the US)
The firm is adding the warning statement to the Instruction for Use for the neoBLUE LED Phototherapy System and provide a laminated Quick Guide to affix to each device.
USA Distribution to the states of : AR, AZ, CA, CO, FL, IL, IN, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NY, OK, OR, PA, SC, TN, TX, VA, WA, WI and Hawaii
The device is reported to enter safe mode and is no longer able to charge batteries.
LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed.      Part numbers:   V15-2-xxxxxx (includes software version 1 and version 2);  V15-5-xxxxxx (inclues software version 4).  The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the environmental conditions specified. The LIFEPAK 15 monitor/defibrillator is designed to be used during ground transportation except when specified otherwise. Manual mode monitoring and therapy functions are intended for use on adult and pediatric patients. Automated external defibrillation mode is intended for use on patients eight years of age and older.
44798 units total (23189 units in US; 21609 units international)
The firm became aware that when using EtC02 in the kPa or % setting and in a situation where the reading is above 9.9 kPa, the display of the LIFEPAK 15 respiratory rate may partially obscure a portion of the leading digit of the EtC02 value. This affects all LIFEPAK 15 with an EtC02 feature installed and configured to the kPa or % setting.
CO, CT, DC, DE, MA, MD, ME, NJ, NY, PA, PR, RI, VA
Oasis Foods Canola Oil, Net Wt. 35 LB (15.88), Distributed by Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 10841 7
Liquid Oil products were reported to contain a high density polyethylene resin trim ring in the 35 lb bottles.
Chef's Quality Creamy Liquid Fry Oil, Net Wt. 35 LBS (15.87 kg), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00482 9
Chef's Quality Corn Oil, Net Wt. 35 LBS (15.87 KG), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00934 3
Silver Source Soy Salad Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food Group, Richmond, VA 23238, UPC 00806795022346
Silver Source Creamy Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food Group, Richmond, VA 23238, UPC 00806795022360
Product Code: FLCR023Y, Lot #01272016 and Product Code: TMCX023Y, Lot #01282016.
Silver Source Clear Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food group, Richmond, VA 23238, UPC 00806795022353
Oasis Foods Creamy Liquid Fry Shortening, Net Wt. 35 LB (15.88), Distributed by Oasis Foods, Inc., Hillside, NJ 07205, UPC 7 32146 10540 9
Product Code: FLCR02OA, Lot #'s 01272016 and 01292016.
Oasis Foods Golden Fry Clear Liquid Shortening, Net Wt. 35 LB (15.88), Distributed by Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 10458 7
Chef's Quality Canola Frying Oil for Heavy Duty Frying, Net Wt. 35 LBS (15.87 KG), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00938 1
Oasis Foods Canola Fry Shortening, Net Wt. 35 LB (15.88), Distributed by: Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 10378 8
Pocahontas Clear Liquid Frying Shortening, Net Wt. 35 LB (15.88), Distributed by Progressive Group Alliance, Inc., Richmond, VA 23228, UPC 7 32146 18196 0
Chef's Quality Clear Liquid Shortening, Net Wt. 35 LBS (15.87 kg), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00481 2
Chef's Quality Soybean Oil, Net Wt. 35 LBS (15.87 kg), Distributed by: RD/JET LLC, 15-24 132nd Street, College Point, NY 11356, UPC 7 60695 00931 2
Ex-Seed Premium Creamy Liquid Shortening, Net Wt. 35 LB (15.88), Distributed by Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 18896 9
Oasis Foods Soybean Cooking & Frying Oil, Net Wt. 35 LB (15.88), Manufactured d by Oasis Foods Company. Hillside, NJ 07205, UPC 7 32146 11212 4
Frosty Acres Restaurant's Pride Advantage Clear Fry Oil, Net Wt. 35 LB (15.88), Packed for F.A.B. Inc., General Offices: Alpharetta, GA 30005, UPC 0 4820054764 2
Masbia Canola Oil, Net Wt. 35 LB (15.88), Distributed by Dependable Food Corp, Edison, NJ 08817, UPC 7 32146 50866 8
Chef's Quality 100% Canola Oil, Net Wt. 35 LBS (15.87 kg), Distributed by: R.D. Enterprises, Inc., College Point, NY 11356, UPC 7 60695 00935  0
Town & Country Pan & Grill Oil Net Wt. 35 LB (15.88), Distributed by: Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 24948 4
Product Code: FLCG02TO, Lot #'s 02042016 and  02082016
Silver Source Clear Canola Fry Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food Group, Richmond, VA 23238, UPC 008 06795 02237 7
Oasis Foods Soybean Oil, Net Wt. 35 LB (15.88), Distributed by Oasis Foods, Inc. Hillside, NJ 07205, UPC 7 32146 11099 1
Silver Source Canola Salad Oil, Net Wt. 35 LB (15.88 kg), Distributed by: Performance Food Group, Richmond, VA 23238, UPC 00806795427707
Product Code: FOCA023Y, Lot #02042016 and Product Code: TMCA02E, Lot #01272016.
Zimmer Trabecular Metal Technology, Inc.
Zimmer Biomet is initiating a recall of specific lots of foil pouched, sterile Trabecular Metal implants that were manufactured between April 2011 and October 2012. The foil pouches are part of a dual barrier system to provide sterile integrity.
POROUS PATELLA 32MM X 10MM - 00587806532    POROUS PATELLA 35MM X 10MM-  00587806535    POROUS PATELLA 38MM X 10MM - 00587806538    POROUS PATELLA 41MM X 10MM - 00587806541
TM MONO TIB STR GRN SZ 5 - 00588606510  TM MONO TIB STR GRN SZ 5 12MM - 00588606512  TM MONO TIB STR GRN SZ 5 14MM - 00588606514   TM MONO TIB STR GRN SZ 5 17MM  - 00588606517  TM MONO TIB STR GRN SZ 6 10MM - 00588606610     TM MONO TIB STR GRN SZ 6 12MM - 00588606612     TM MONO TIB STR GRN SZ 6 14MM - 00588606614  TM MONO TIB STR GRN SZ 6 17MM - 00588606617  TM MONO TIB STR BLUE SZ 7 10MM - 00588606710  TM MONO TIB STR BLUE SZ 7 12MM - 00588606712  TM MONO TIB STR BLUE SZ 7 14MM - 00588606714  TM MONO TIB STR BLUE SZ 7 17MM - 00588606717   TM MONO TIB STR GRN SZ 5 10MM - 00588607510  TM MONO TIB STR GRN SZ 5 12MM - 00588607512  TM MONO TIB STR GRN SZ 5 14MM - 00588607514   TM MONO TIB STR GRN SZ 5 17MM - 00588607517
Navilyst Medical, Inc., an AngioDyamics Company
Worldwide Distribution US (Nationwide)  Internationally  to AU, GR, SE, SA, IN, CA, GB, BR, BE, NL, ES, KR, HK, AE, IT and ES.
Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001455910, Rx ONLY  The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC catheter.
BioFlo PICC with ENDEXO and PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965458410, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
Vaxcel PICC with PASV IR-145 Kit under the following labels: 1) 4F, UPN M001454580, Rx ONLY, 2) 5F, UPN M001454630, Rx ONLY & 3) 6F, UPN M001454780, Rx ONLY  The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
Xcela Hybrid PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965952440 & UPN H965952450, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, Catheter Kit, UPN H965459410, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458970, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
BioFlo Hybrid PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458980, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
BioFlo PICC with ENDEXO and PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965458420 & UPN H965458930, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
Xcela PICC with PASV Valve Technology Catheter Kit, 6F-55cm, UPN H965457410, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
Vaxcel PICC with PASV Catheter Kit under the following labels: 1) 3F, UPN H965454350, Rx ONLY, 2) 4F, UPN M001454550, Rx ONLY & 3) 5F, UPN M001454700, Rx ONLY.  The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
Vaxcel PICC with PASV Introducer Kit under the following labels: 1) 4F, UPN M001454560, Rx ONLY & 2) 5F, UPN M001454610, Rx ONLY.  The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
BioFlo PICC with ENDEXO and PASV Valve Technology, MST-45 Kit, 6F-55cm, UPN H965458440 , Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
Xcela PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965251290 & H965457420, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
Xcela Hybrid PICC with PASV Valve Technology, Catheter Kit, 6F-55cm, UPN H965952410, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
Xcela Hybrid PICC with PASV Valve Technology, MST-70 Kit, 6F-55cm, UPN H965952420 & UPN H965952460, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
Xcela PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965457430, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
Vaxcel PICC with PASV MST-30 Kit under the following labels: 1) 4F, UPN M001454570, Rx ONLY, 2) 5F, UPN M001454620 & UPN M001454720, Rx ONLY & 3) 6F, UPN M001454770, Rx ONLY.  The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
Vaxcel PICC with PASV Intermediate Safety MST Kit under the following labels: 1) 3F, UPN H965454370, 2) 4F UPN M001455940 & 3) 5F UPN M001455980  The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
Xcela PICC with PASV Valve Technology, Intermediate MST-45 Kit, 6F-55cm, UPN H965457440  Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
BioFlo PICC with ENDEXO and PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965458430 & UPN H965458840, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
Vaxcel PICC with PASV MST-60 Kit under the following labels: 1) 3F, UPN H965454360, Rx ONLY, 2) 4F, UPN M001454590, Rx ONLY, 3) 5F, UPN's M001454640, M001454740 & M001454790, Rx ONLY  The Vaxcel PICC with PASV is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy, and blood products. It is also indicated for blood specimen withdrawal. This product is intended for central venous access in adults, children and infants who require intravenous (IV) therapy.
Xcela Hybrid PICC with PASV Valve Technology, IR-145 Kit, 6F-55cm, UPN H965952430 & H965952470, Rx ONLY  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
BioFlo PICC with ENDEXO and PASV Valve Technology, Maximal Barrier Nursing Kit, UPN H965750211  The Xcela PICC with PASV, Xcela Hybrid PICC with PASV, BioFlo PICC with PASV and BioFlo Hybrid PICC with PASV are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications and nutrients; the sampling of blood; and for power injection of contrast media. Non-valve lumens are indicated for central venous pressure monitoring
The Clight brand products in flavors Orange, Lemon, Tangerine, and Lemon Tea contain a small amount of soy lecithin but are not labeled to declare soy lecithin in the ingredient list and do not otherwise disclose soy as an ingredient.
Worldwide Distribution - US Distribution including the countries of  Switzerland, Germany..
Protura Robotic Couch System Software, versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1), CIVCO, Orange City, IA 51041
When using the recalled product in split shift mode, the non-sub-millimeter positioning has been found to be inconsistent with the setting parameters.
Versions 1.6.1 (Part Number MT6XSM1.6.1), 1.7.0 (Part Number MT6XSM1.7.0), and 1.7.1 (Part Number MT6XSM1.7.1)
AZ, CA, CO,  FL, IL, KY, ME, MN, NC, NJ, NY, NV, OH, OK, PA, TN, TX, UT, and WI; Foreign accounts: Columbia.
Sugar, Frozen Pre-cut Cookie Dough, Net Weight 24.61 lbs/11.16 kgs and 23.44 lbs/10.64 kgs.
Oatmeal Raisin, TranSmart Frozen Pre-cut Cookie Dough, Contains Approx. 120 Cookies, Net Weight 22.5 lbs (10.22 kgs).
Chocolate Chip, Frozen Pre-cut Cookie Dough, Net Weight: 24.61 lbs/11.17 kgs and 23.44 lbs/10.63 kgs.
TranSmart, Sugar Cookie, 240  1.5 oz. Cookies, Net Weight: 22.5 lbs/10.21 kg.
Chocolate Chip, TranSmart, Frozen Pre-cut Cookie Dough, Net Weight 22.5 lbs (10.22 kgs).
4 oz. Cranberry Nut Crunch Cookie Dough, TransSmart, Net Weight 24 lbs (10.88 kg).
TranSmart, 4 oz. Oatmeal Raisin Walnut Cookie Dough, Net Weight 24 lbs (10.88 kg).
1 oz. Dutch Cupboard, Oatmeal Raisin Cookie Dough, Net Weight: 22.5 lbs (10.20 kg).
TranSmart, White Chocolate Chip Fudge Cookie, 240  1.5 oz. Cookies, Net Weight: 22.5 lbs/10.21 kg.
TranSmart, Ginger Cookie, 300-1.2oz Cookies, Net Weight 22.5 lbs/10.22 kg (Frozen).
Chocolate Chip Cookie, Net Weight: 21 lbs (9.53 kgs).
Oatmeal Raisin, Frozen Pre-cut Cookie Dough, Net Weight 23.44 lbs/10.63 kgs and 24.61 lbs (11.16 kgs)
1.25 oz. TranSmart, Chocolate Chip Cookie Dough, Net Weight: 23.44 lbs. (10.63 kg).
TranSmart, 12 Chocolate Chip Message Cookie, 24/24 ounce chocolate chip cookies in Bakeable Plastic Pans with Domes, Net Weight 36 lbs/16.33 kg.
7 Eleven, Sugar Cookie (2.2 oz. Pucks), Net Weight 33 lbs (14.96 kg), Manufactured by; CSM Bakery, Tucker, GA 30084.
7 Eleven, Oatmeal Raisin Cookie (2.2 oz. Pucks)/ Net Weight 33 lbs (14.96 kg), Made in the USA By: CSM Bakery, Inc., Tucker, GA 30084.
Dutch Cupboard, Sugar Cookie Dough, 360  1.1 ounce cookies, Net Weight: 24.75 lbs/11.24 kgs.
0.5 oz. TranSmart, Mini Chocolate Chip Cookie Dough, Net Weight 22.5 lbs (10.20 kgs).
TranSmart, Sugar Cookie Dough, 576/0.75 ounce cookies, Net Weight 27 lbs/12.26 kgs and 96/4 ounce cookies, Net Weight 24 lbs/10.9 kgs.
TranSmart, Brownie Milk Chocolate Chip Cookie, 180  1 ounce cookies, Net Weight: 11.25 lbs/5.10 kg.
FLIK, ZT Thin & Crispy Chocolate Chip Cookies, Contains 300 cookies weighing approximately 1.2 oz, Net Weight 22.5 lbs (10.2 kg), Manufactured for FLIK International, Rye Brook, NY 10573.
Cinnabon Caramel Pecan, 3 oz. Cookie, Net Weight 23.45 lbs. (10.63 kg).
TranSmart, 1.2 oz. Sugar Cookie, Net Weight: 22.5 lbs (10.2 kg).
Brill, New Cookie, Chocolate Chunk, No Thaw, 160-2.75 oz. Cookies, Net Weight 27.5 lbs. (12.47 kg), Produced for Chick-Fil-A, Inc., Manufactured by: CSM bakery Products NA, Inc., Tucker, GA 30084.
TranSmart, Chocolate Chip Cookie, 240  1.5oz cookies, Net Weight 22.5 lbs/10.21 kg.
TransSmart, Brownie Cookie, 300  1.2oz Cookies, Net Weight 22.5 lbs/10.22 kg.
Candy Frozen Cookie Pucks 0.75oz, Keep Frozen, Net Weight 27 lbs (12.24 kg).
7 Eleven, Chocolate Chunk Cookie (2.2 oz Pucks), Net Weight 33 lb (14.96 kg).
2 oz. TranSmart, Macadamia White Chocolate Cookie Dough, Net Weight 30 lbs (13.6 kg).
Macadamia Nut Cookie With White Drops, Frozen Pre-cut Cookie Dough, Net Weight: 23.44 lbs/10.64 kgs. And 24.61 lbs/1/16 kgs.
Cinnabon Cinnamon Chip, 3 oz. Cookie, Net Weight 23.43 lbs (10.63 kg).
Macadamia Nut Cookie with White Drops, TranSmart, Frozen Pre-cut Cookie Cough, Net Weight 22.5 lbs (10.22 kgs).
TranSmart White Chunk Macadamia Nut, 168  2.5 oz. Cookies, Net Weight: 26.25 lbs 11.91 kg.
Chocolate Chip with Colored Candy Pieces, Frozen Pre-cut Cookie Dough, Net Weight; 24.61 lbs/11.17 kgs. and 23.44 lbs/10.64 kgs.
4 oz. Macadamia Nut Cookie Dough, TranSmart, Net Weight 24 lbs/10.9 kg.
TranSmart Gourmet Mini Bites Wedding Cookie, 576, .75oz cookies, Net Wt 27 lbs/12.26 kg.
ARBYS Salted Caramel Chocolate Cookie, Net Weight 22.96 lbs (10.41 kg).
12 RND M.C. (No Trans), For Bake, Net Weight 46.2 lbs/20.96 kg.
0.5 oz. TranSmart, Mini Chocolate Chip Cookies with M&Ms, Net Weight 22.5 lbs (10.20 kg).
0.5 oz. TranSmart, Mini Sugar Cookie Dough, Net Weight 22.5 lbs (10.20 kg).
0.75 oz. TransSmart, Gourmet Mini Bites, Brownie Cookie Dough, Net Wt: 27 lbs (12.24 kg).
Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0.75% in a 30 mL Single Dose Vial, Rx only, Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-472-37
Presence of Particulate Matter: Glass particulate found in sterile injectable product
Lab testing revealed the recalled product tested positive for trace amounts of peanuts.
Rose Red Organic Ginger Steam Filter Bag & Organic Ground Ginger Steam packaged in a poly-lined corrugated carton; 40 lb case  bulk pack 40 lbs
A positive result was discovered for Salmonella in Rose Red Filterbag Ginger and Organic Ground Ginger.
Gourmet Cranberry Crunch Cookies, UPC 0007203695600, 4 Ct (Pack 24/4 Ct)
12 Inch Message Cookies, UPC 0007203695587, 1 Pk (Pack 24/1 Ct)
Gourmet White Chocolate Macadamia Cookies, UPC 0007203695132, 4 Ct (Pack 24/4 Ct)
Gourmet Oatmeal Raisin Walnut Cookies, UPC 0007203695193, 4 Ct (Pack 24/4 Ct)
12 Count Sugar Cookies, UPC 0007203695601, 12 Ct (Pack 25/12 Ct)
Vancomycin Hydrochloride for Injection, USP, 10 g, 100 mL vial, Rx only, Hospira, Lake Forest, IL, NDC 0409-6510-01
Presence of Particulate Matter: Cardboard
White Cupcakes with Pink Icing, UPC #10074865110140
White Cupcakes with Yellow Icing, UPC #10074865110157
White Cupcakes with White Icing, UPC #10074865110102
White Cupcakes with Blue Icing, UPC #10074865110164
Brookshire Brothers LTD-Central Bakery Plant
Fresh Harvest Ice NET WT 8 LB and Fresh Harvest Ice NET WT 16 LB packaged in clear plastic bags
Red Blood Cells, Leukocytes Reduced, Irradiated
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
Blood product, collected from a donor who had traveled to a malarial endemic area, was distributed.
Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe).  For flushing of IV catheters and IV tubing only.
Certain lots of Heparin Lock Flush, USP Syringes (5 ml Fill in 10 ml Syringe) failed Anti-Factor IIa assay for potency during testing of retention samples for heparin potency.
Genzyme Corporation / Genzyme Biosurgery
Hectorol (doxercalciferol injection) 2 mcg/1mL, Rx only,  Manufactured by: Genzyme Biosurgery Corporation 500 Kendall Street, Cambridge, MA 02142, NDC 58468-0126-1
Labeling: Wrong barcode. An incorrect bar code was noted on the vial label of Hectorol 2 mcg/1mL vial.
Apheresis Red Blood Cells, Leukocytes Reduced
Blood products, mislabeled and/ or missing labeling  information, were distributed.
Apheresis Fresh Frozen Plasma, Irradiated
Blood products, in which labels applied to blood units or products incorrect or missing information, were distributed.
STAAR AQ Cartridge-FP,  guide and delivery system for Intraocular lenses.
The STAAR AQ Cartridge-FP may malfunction and may crack during loading or delivery of the IOL (Intraocular Lenses).
Blood and Blood Products for Reprocessing
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Blood product, which was collected from a donor who traveled to malarial endemic areas, was distributed.
Central Texas Regional Blood & Tissue Center
Blood products, which did not meet the acceptable product specifications, were distributed.
LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones.
Product incorrectly packaged.  The labels on the outside of the box and on the LCP Dia-Meta Volar Distal Radius Plate inside the box are correct; however, the preprinted box which contains the LCP-Dia-Meta Volar Distal Radius Plate is incorrect.  The box is preprinted for a 4.5 mm LCP Condylar Plate - Distal Femur.
Lot Number 9890811, Catalog ID 02.110.115S
Distributed in the states of CA, CO, FL, GA, IL, IN, KS, MD, NC, NY, PA, SC, VA, WA, and WI.
BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Potential for polystyrene particulate presence.
BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot.
Distributed to Publix retail stores in AL, FL, GA, NC, SC, & TN
Publix Deli, Wheatberry Salad,  sold in 3.5 oz clamshell, 1 lb Grab and Go kit, and Chef Select custom order behind the deli counter.  Received at retail store as a 12.75 lbs kit.  Ingredients are combined at retail store.  Manufactured for Publix Supermarkets in Lakeland, FL
Potential contamination with Listeria monocytogenes.
All lot codes, all expiration dates.  last ship date 04/30/2016.
NATIONWIDE and FOREIGN CONSIGNEES: Japan, Taiwan, Thailand and South Korea.
Cordis PRECISE (R)  RX Nitinol Stent System (Biliary)
4,400 units in US; 3,100 units to Foreign Countries
Inability to deploy the stent or partial stent deployment.
Catalog Number:  P05030RXB, Lot Number: 17241836; Catalog Number: P09030RXB, Lot Number:  17241838; Catalog Number: P07030RXB, Lot Number : 17291878;  Catalog Number: P07040RXB, Lot Number:  17291879;  Catalog Number: P06040RXB, Lot Number:  17415243.
Cordis PRECISE (R) PRO RX Nitinol Stent System (Carotid)
4,400 units in US and 3,100 units in Foreign Countries
Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.
AVEA GDE upgrade kit, 12284-PMN  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
CareFusion has identified a potential risk associated with AVEA Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).
Gas Delivery Engine (GDE), 16650A  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
AVEA  Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14)  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
AVEA GDE/UIM upgrade kit, 12283-PMN  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Gas Delivery Engine (GDE)-1st Generation, 16222-001-99  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
AVEA Standard with Compressor ventilator, 17312-xx  (xx = 0 - 14)  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
TCA Board, 16542A  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
AVEA  Comprehensive ventilator, 17310-xx  (xx = 0 - 14)  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14)  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
AVEA Standard ventilator, 17311-xx  (xx = 0 - 14)  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14)  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
Gas Delivery Engine (GDE)-refurbished, R16650A  A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
US Distribution to states of: CO, FL, IL, MI, NJ, NY, SC, TX, and VA.
TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws    The FS2030 Depth Gauge is used by the physician to determine the correct screw length when implanting a 2.0 or 2.5mm TS Series screw for the Ti6 Internal Fixation System.
Blood product, altered in a manner that possibly compromised sterility, was distributed.
Blood products, which did not meet the acceptable product specifications for release, were distributed.
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, in which quality control and distribution of products did not meet specifications, were distributed.
Worldwide Distribution -- US, including the states of AL, AZ, CA, CO, FL, GA, IL, MD, MI, MO, NM, NY, OH, TX, UT, and VA; and, the country of Dominican Republic.
The Red Head 2 Reusable Fat Harvesting Canister, Product # RH-2, Non-Sterile.     Intended for use in aspirating subcutaneous fatty tissue in patients desiring aesthetic body contouring and autologous fat collection.
During an FDA inspection it was found that the products are marketed without a cleared 510k, nor is approved for multiple use.
Undeclared allergens; wheat, soy and tree nuts (almonds).
U.S. consignees: Nationwide; Foreign Consignees: China, Japan, Russia, Italy and England.
Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape.     This particular Ariol software application is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed paraffin-embedded tissue specimens immunohistochemically stained for Estrogens Receptors or Progesterone Receptors (ER/PR). ER/PR results are indicated for use as and aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.
An issue during the manufacturing process caused systems to have an improperly activated Windows 7 OS, even though a valid Windows 7 license was associated with each manufactured system.
Nitrofurantoin Oral Suspension, USP, 25 mg/5 mL, FOR ORAL USE ONLY, URINARY TRACT ANTIBACTERIAL, Rx Only , 240 mL bottle, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Mfg. by: Sun Pharmaceutical Industries, Inc., Bryan, Ohio 43506, NDC 57664-239-32
Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to administer aerosolized medication from most pressurized Metered Dose Inhalers(pMDIs).
Product had torn/loose seal around the mouthpiece.
Blood products, collected from a donor who disclosed travel history to a malarial endemic area, were distributed.
Nationwide Distribution to AZ, CA, CO, GA, IL, KS, KY, MA, MD, MO, OH, PA, TN, and TX.
Dome Centric component (Reference 01.04227.005) from the Anatomical Shoulder (AS) System 2.0.  The Dome Centric connects the Humeral Stem to the Humeral Head and allows setting an inclination and retroversion positioning.  The Anatomical Shoulder System is intended for long-term implantation into the human shoulder joint in primary or revision, total or hemi shoulder arthroplasty. The system is intended to relieve pain and restore function in patients with adequate bone stock to support the prosthesis.
In some cases it has been difficult or not possible to disassemble the adjusted Dome Centric from the AS Humeral Rasp after initial positioning of the AS Humeral Trial Head which resulted in the whole construct of the Dome Centric with the still assembled AS Humeral Rasp taken out of the humeral canal. This could cause a delay in surgery time or the surgeon could decide to close the wound without finishing the surgery,  increasing the infection risk or second use of anesthesia necessary.
Stryker Medical Division of Stryker Corporation
Distributed US (nationwide) and the countries of Australia, Canada, Hong Kong, Spain, Switzerland, and United Kingdom.
are powered ambulance cots are designed to support and transport a maximum weight of 700 lb. (318 kg) in pre-hospital and hospital environments.
Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only.  Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30.
Labeling: Incorrect Or Missing Lot and/or Exp Date: Some expiries and lot numbers are missing.
Lodrane D (Brompheniramine maleate 4 mg and Pseudoephedrine HCl 60 mg) Capsules, 60-count bottles, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ  08807, UPC 0 00950 86006 8.
Labeling: Not Elsewhere Classified: correctly labeled bottles were packaged in cartons that were mislabeled with an incorrect active ingredient, phenylephrine rather than pseudoephedrine, on the carton face and carton top.
AL, AZ, CA, CO, DC, FL, GA, IN, KS, KY, MD, MI, NE, NV, NY, OH, OK, TX, WA
Piccolo Composite Tibia and Femoral Nailing Systems - Ball Tip Guide Wire for fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.
Firm received complaints where the Piccolo Composite Ball Tip Guide Wire penetrated the internal package, and thus compromised the product sterility.
Worldwide Distribution - US Nationwide and the countries of  China and Malaysia.
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10528956    Product Usage:  The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
The bracket that is used to lift the cover has bolts that were not welded in potentially causing the cover to fall down during service.
Biograph mCT-S(64) 4R, MATERIAL NUMBER 10248672    Product Usage:  The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT S(20) - 3R, MATERIAL NUMBER 10507786    Product Usage:  The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
BIOGRAPH mCT S(20) - 4R, MATERIAL NUMBER 10528958    Product Usage:  The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.
Pramipexole Dihydrochloride Extended Release  Tablets, 0.375 mg, Rx Only, 30 count bottles, Manufactured By: Par Pharmaceutical Companies, Inc., Chestnut Ridge, NY 10977, NDC 10370-251-11
Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.
Alabama; Puerto Rico; Tennessee; Virginia; Georgia
Blood products, collected in a manner with a potential for air contamination, were distributed.
Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only,  Manufactured by Sandoz  Inc., Princeton, NJ 08540, NDC 0185-0630-01
Labeling: Incorrect or Missing Package Insert
Blood products, collected from a donor with a history of Viral Hepatitis, were distributed.
Apheresis Platelet products for which pH testing was invalid, were distributed.
Apheresis Platelets, Leukocytes Reduced, Irradiated
Apheresis products, in which quality control for residual WBC count was not performed, were distributed.
Custom Tubing Set BEQ-TOP-24100 (Small Patient ECC Pack) was identified as possessing a level of endotoxin that exceeded the regulatory limits.
Blood products, collected from a donor who received a piercing within one year of donation, were distributed.
Oklahoma Blood Institute - Sylvan N Goldman Center
Apheresis products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Blood products, collected from a donor for whom eligibility was inadequately determined, were distributed.