Worldwide Distribution - Nationwide to CA, CO, FL, IN, MD, MN, NC, NY, OH, TX, UT & VA;  International: Canada, Wales
Hip Preservation System Signature Series PreBent Burs under the following labels: 1) PreBent Spherical Bur, 5.5mm x 19cm Catalog Number HPS-HB11, 2) PreBent Polishing Bur, 5.5mm x 19cm Catalog Number HPS-HB12 and 3) PreBent Oval Bur, 6.0mm x 19cm Catalog Number HPS-HB13  The ConMed Hip Preservation System Signature Series is intended to be used for resection of osseous tissue (bone) in arthroscopic and endoscopic surgical procedures
Metal shavings released from burs during use are due to contact between the bur and the hood of the PreBent Bur assembly.  During the manufacturing process an assembly error occurred which caused inadvertent mixing of two sizes of bearings.
Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.
Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 13, Femoral Stem,  Catalog Number 160-00-13; For use in primary total hip arthroplasty.
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Product Codes:  LPH, MEH, LWJ, JDI;  Catalog Number 160-00-13, Serial Numbers: 4333544, 4333545, 4333546, Exp.3/22/2021 and Serial Number 4335281,  Exp. 3/23/2021.
Novation Press-Fit Tapered, Standard Offset, HA Coated, 12/14 Taper,  Femoral Stem;  Catalog Number 160-10-16; For use in primary total hip arthroplasty.
Product Codes:  LPH, MEH, LWJ, JDI;  Catalog Number 160-10-16, Serial Number: 4256338, Exp. 1/27/2021.
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup),  Catalog Number 140-01-56;  For use in primary total hip arthroplasty.
Product Code: MRA,  Catalog Number 140-01-56, Serial Numbers:  4268399 and 4268400, Exp. 2/6/2021.
Novation Press-Fit Tapered, Standard Offset, 12/14 Taper, Size 14, Femoral Stem,  Catalog Number 160-00-14; For use in primary total hip arthroplasty.
Product Codes:  LPH, MEH, LWJ, JDI;  Catalog Number 160-00-14, Serial Number: 4252802, Exp. 1/25/2021.
Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11,   Femoral Stem;  Catalog Number 160-30-11; For use in primary total hip arthroplasty.
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup),  Catalog Number 140-01-54; For use in primary total hip arthroplasty.
Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility.
Distributed US (nationwide) and the countries of Canada, Austria, Belgium, Columbia, Croatia, France, Germany, Guadeloupe, Ireland, Italy, La Reunion,   New Zealand, Norway, Poland, Portugal, Saudi Arabia, South Africa, Spain,  Sweden and United Kingdom.
Compromised sterility due to breach of barrier
All lots beginning with 110000233562 through lot 120002651262X
All lots beginning with 110000142862 through lot 130002191062X
All lots beginning with 110001420362 through lot 15C151862X
All lots beginning with 110001358162 through lot 15C033262X
All lots beginning with 110000311162 through lot 15J101262X
All lots beginning with 100000010062 through lot 15J162962X
(10.2 cm x 10.2 cm), Sterile 10's in Soft Pouch; Item Number:  397310; Open mesh fabric intended to be used to inside the body or a surgical incision to control bleeding, absorb fluid, or protect organs.
All lots beginning with 110000037462 through Lot 120002259962
All lots beginning with 110000161662 through lot 15G255462X
All lots beginning with 110000463762 through lot 15K235262
All lots beginning with 110000476162 through lot 15J070162X
All lots beginning with 110000311262 through lot 15G162262X
All lots beginning with 100000009962 through lot 15J163262X
All lots beginning with 100000055262 through lot 15B223462X
Endoscope  ED-250XL5 Operations Manual: Cleaning, Disinfection
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Endoscope  ED-450XT5  Operation Manual: Cleaning, Disinfection and Storage
Endoscope; ED-530XT Operation Manual  'Operation and Preparation' and 'Cleaning, Disinfection and Storage'
Endoscope  ED-250XT5  Operations Manual: Cleaning Disinfection and Storage
Endoscope  ED-450XL5  Operation Manual: Cleaning, Disinfection and Storage
EVIS EXERA Duodenovideoscope Olympus TJF Type 160F/VF  used with an Olympus video system center, light source, documentation equipment monitors, Endo Therapy accessories and other ancillary equipment for endoscopy and endoscopic surgery within the duodenum.
New reprocessing instructions for the Olympus TJF-160/VF duodenoscopes, consisting of revised manual cleaning and high level disinfection procedures they plan to implement as well as a new cleaning brush (MAJ-1534), which is enclosed with the notification.
Models: TJF-160F and TJF-160VF, all serial numbers
Pneumatic Impactor, General Surgery, With Microaire Hose Connector     Professional Use, Medical Industry
MicroAire discovered that 20 suspect Impactor instruments ( MicroAire Pneumatic Impactor) were shipped to end users and were missing the lock and unlock symbol markings on them.
Nationwide Distribution to AZ, CA, CO, CT, FL, GA, LA, MD, MI, NJ, NY, PA, TX, VA, and WA.
AllergiEnd ST-9 Multiple Skin Test Applicator (Item 1000) and AllergiEnd ST-9 Multiple Well Test Tray (Item (1001). Contents: 8 applicators to perform up to 72 skin tests.  Perform a multi-site skin test to identify reactions to certain allergens using a non-invasive applicator that contains 70 different allergens and histamine
During an FDA inspection it was found that the products are marketed without a cleared 510k.
Product distributed nationwide an internationally to the following countries: Egypt, Bermuda, and United Arab Emirates
Fruit Tartlets, lemon flavor, 9 - 0.53oz (15 g) tartlets - Net Wt. 4.8 oz (135 g).  Manufactured in France.  Distributed by Ouhlala Gourmet Corp. dba Buddy Fruits, Coral Gables, FL
Products contain undeclared milk on finished product labeling
Fruit Tartlets, Raspberry flavor, 9 - 0.56oz (16 g) tartlets - Net Wt. 5.1oz (145 g).  Manufactured in France.  Distributed by Ouhlala Gourmet Corp. dba Buddy Fruits, Coral Gables, FL
AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI
Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments
Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.
Catalogue No: CEV669E.     All batch numbers distributed from January 2011 to February 17, 2016.
LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle,  Manufactured for Continuum Labs, Fort Lauderdale, FL
Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033
Worldwide distribution.  US states: VA, VT, UT, GA, NJ, and IL; Japan.
Ergon III Series Skyboom Monitor Bracket.  Part # 3FCM1 Flatscreen Bracket, single monitor mount, 27inch max. screen size
Potential for the weld to fail at the pivot point of the monitor bracket.  This weld failure could cause the display interface and bracket to fall from its mounted location, resulting in injury.
Nationwide distribution to Louisiana and Montana.
Laparotomy Pack Latex Free, part number 007725-7.  This is a custom convenience surgical instrument disposable kit.      There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.
These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.
General Surgery Pack, part number 006880-3.  This is a custom convenience surgical instrument disposable kit.      There are multiple component in this kit and the recalled item subject to recall is Medtronic Kerlix X-Ray Detectable Laparotomy Sponges.
Nationwide distribution to AZ, MS, NY, MO, FL, WI, TX, FL, and CA.
STAT-Check Resuscitation Bag  Manual Emergency Resuscitation Bag with Carbon dioxide gas analyzer  Intended for use in various clinical situations to provide respiratory support in the presence of reversible apnea commonly associated with respiratory arrest. The device should only be used by personnel trained in CPR procedures. The ACE/STAT-Check II is intended for use as an adjunct assessment tool for verification of successful ventilation / intubation in patients > 2.2 kilograms (5lbs.).
Stat-check CO2 indicators are non-functional.  The indicator is yellow when not in use and should be purple when not in use.  The yellow indicates a 5% CO2 level, cardiac massage and ventiliation being performed correctly.  The color will not change during use and will not be an indicator of CO2 level or improper performance of cardiac message and ventilation.
Model SC9001B  Adult STAT-Check Resuscitation Bag w/ Inflatable Bag Reservoir & Mask  Lot numbers 303320 and 303612    Model SC9001C  Adult STAT-Check Resuscitation Bag w/ Corrugate Tube Reservoir & Mask  Lot number 303400    Model SC9001C-C  Adult STAT-Check Resuscitation Bag w/ Corrugate Tube Reservoir, Mask & Straight Connector  Lot numbers 303523 and 303791    Model SC8001B  Pediatric STAT-Check Resuscitation Bag w/ Inflatable Bag Reservoir & Mask  Lot number 303833
Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.
Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.
Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the expiry date on the product labeling.
1ml size Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) with lot numbers 6036120, 6032345 and 6023543.
Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling.
1ml size Novocastr Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) with lot numbers 6032734, 6033766, 6037153 and 6039088.
Worldwide Distribution --  US, to the following states: AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH, NJ, NV, NY, OH, OK, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY; and, the countries of ALBANIA, ALGERIA, ANGOLA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BANGLADESH, BELARUS, BELGIUM, BOLIVIA, BOSNIA AND HERZEGOVI, BRAZIL, BRUNEI, BULGARIA, CAMEROON, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CROATIA, CYPRUS, CZECH REPUBLIC, DENMARK, ECUADOR, EGYPT, EL SALVADOR, ESTONIA, ETHIOPIA, FINLAND, FRANCE, GAZA & JERICHO, GEORGIA, GERMANY, GREECE, GUATEMALA, HONDURAS, HUNGARY, INDIA, INDONESIA, IRAN, IRELAND, ISRAEL, ITALY, IVORY COAST, JAMAICA, JAPAN, JORDAN, KAZAKHSTAN, KENYA, KUWAIT, KYRGYZSTAN, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MACEDONIA, MALAYSIA, MALDIVES, MALI, MAURITIUS, MEXICO, MONTENEGRO, MOROCCO, NETHERLANDS, NEW ZEALAND, NIGERIA, NORWAY, OMAN, PAKISTAN, PARAGUAY, PERU, PHILIPPINES, POLAND, PORTUGAL, QATAR, REPUBLIC OF YEMEN, ROMANIA, RUSSIA, SAUDI ARABIA, SENEGAL, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SRI LANKA, SWEDEN, SWITZERLAND, TAIWAN, TANZANIA, THAILAND, TOGO, TRINIDAD & TOBAGO, TUNISIA, TURKEY, UAE, UKRAINE, UNITED KINGDOM, URUGUAY, VENEZUELA, VIETNAM and ZIMBABWE.
The ARCHITECT Estradiol Kit     Intended to measure estradiol, an estrogenic steroid, in plasma.
Interaction of Fulvestrant with the ARCHITECT Estradiol assay, leading to falsely elevated estradiol results in patients treated with Fulvestrant.
Product List Number 07K7220 with Lot #: 55900UI01with expiration date of 04/23/2016, Lot #: 55908UI01 with expiration date of 04/29/2016, Lot #: 55941UI00 with expiration date of 04/23/2016, Lot #: 57929UI00 with expiration date of 07/16/2016, Lot #: 57931UI01 with expiration date of 07/27/2016, Lot #: 60105UI00 with expiration date of 10/02/2016 and Lot #: 61106UI00 with expiration date of 11/27/2016.    Product List Number 07K7225 - Lot #: 55900UI00 with expiration date of 04/23/2016, Lot #:  55908UI00 with expiration date of 04/29/2016,  Lot #:  57929UI01 with expiration date of 07/16/2016, Lot #: 57931UI00 with expiration date of 08/27/2016, Lot #: 60105UI01 with expiration date of 02/10/2016, Lot #: 61106UI01 with expiration date of 11/27/2016 and Lot #:  62263UI00 with expiration date of 11/27/2016.
U.S. Including: CA, CT, MA, MD, NY, NJ, OK, TX, and WA
Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 098, (Maharashtra) India.
CGMP Deviations: active pharmaceutical ingredient intermediates failed specifications.
Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC 68180-633-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-633-01.
Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 68180-611-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA.
HAWAIIAN DELIGHT ING: IMITATION SOUR DRESSING, PEACHES, PINEAPPLE, MANDERIN ORANGES, SUGAR CHERRIES KEEP REFRIGERATED NET WT. 4.5 LB. & 9 LB. (4.06KG) (2.03KG) F.L. HARTER & SONS INC. CINCINNATI, OHIO 45211
96 CS/2/4.5 lb containers + 139 cs/2/9lb containers
The firm failed to include the allergens, Milk and Soy, on the label.
SPINACH DIP ING: VEGETABLE SOUP MIX, MAYONAISE, SOUR CREAM, SPINACH, WATER CHESTNUTS, DRY ONIONS KEEP REFRIGERATED NET WT. 5LB. (KG) F.L.HARTER & SONS INC. CINCINNATI, OHIO 45211
PASTA SALAD ING: PASTA, ITALIAN DRESSING, DRY ONIONS, PARSLEY, RED PEPPERS, PARMESON CHEESE, SPICES. CONTAINS MILK KEEP REFRIGERATED NET WEIGHT 5LB.(2.26KG.) F.L. HARTER & SONS INC. 3778 FRONDORF AVE. CINTI OH. 45211
US: AL, AR, CA, CO, FL, GA, IN,IA, KY, MD, MA, MI, MN, MO, NV, NJ, NC, OH, OK, OR, PA,, SC, TN, TX, VA, WA, WV, WI.    Canada
Reprocessed Microline Scissor Tips intended to be used with a reusable hand piece and designed for minimally invasive and open surgical procedures to facilitate cutting, preparation, mobilization, and coagulation of tissue. Model #'s MIC3112, MIC3122, MIC3132, MIC3142, MIC3152, MIC3162.
Sterlilmed is recalling all unexpired Scissor Tips because of a potential manufacturing defect that can possibly result in a patient injury.
Nationwide Distribution to AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, , ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and Puerto Rico.
Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2,  Device listing # D011374, All serial numbers and lots are affected.  The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use
Discrepant patient results on Dimension Vista Intelligent Lab Systems.  Siemens Healthcare confirmed a software defect which, in a very specific set of circumstances, results in the Dimension Vista System omitting an aliquot probe rinse between sample aspirations when processing tubes in Sample Racks that are front loaded on the Dimension Vista System.
Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2,  Device listing # D011374, All serial numbers and lots are affected.  The Dimension Vista System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Dimension Vista chemical and immunochemical applications use photometric, turbidimetric, chemiluminescence, nephelometric and integrated ion-selective multisensor technology for clinical use
Baptist Health Medical Towers Pharmacy and Infusion Services
Deferoxamine 2 grams/51 mL NS cassette, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
70% Ethanol-lock Solution, 2 mL Syringe, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Water for Injection 1000 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas
Ascorbic Acid 500 mg (1 mL) Syringe, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Ceftriaxone 2 gram in 100 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Meropenem 2 grams in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Vancomycin 1 grams in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Clindamycin 900 mg in 100 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
1/2 Normal Saline 2000 mL + Sodium Acetate 80 mEq., FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Deferoxamine 4 grams/NS 101 mL Cassette, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
0.9% Sodium Chloride a) 500 mL b) 2000 mL and c) 3000 mL bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Vancomycin 1750 mg in 270 mL 0.9% NS bag,FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Vancomycin 1000 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Vancomycin 2 grams in 540 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Daptomycin 650 mg in 50 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Vancomycin 750 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Ceftriaxone 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Piperacillin-Tazobactam 10.125 grams/NS 307 mL BAG, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Milrinone 200 mcg/mL in  a) D5W-300 mL, b) D5W-400 mL, c) D5W-500 mL and d) D5W-600 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
a) 15 bags, b) 15 bags, c) 15 bags, d) 4 bags
Dobutamine 2000 mcg/mL in a) D5W-500 mL, b) D5W-750 mL, c) D5W-1000 mL, d) D5W-1750 mL Bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
a) 10 bags, b) 23 bags, c) 9 bags, d) 6 bags
Piperacillin-Tazobactam 13.5 grams/NS 322 mL bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
TPN 1, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas
Sodium Chloride 0.9% 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Hydromorphone 2 mg/mL (500 mg in 250 mL NS) bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Nafcillin 12 grams in 322 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
TPN 2, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock Arkansas
Cefazolin 6 grams in 292 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, Arkansas
D5 1/2 NS 1000 mL with Electrolytes bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Remicade 600 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Vancomycin 1250 mg in 250 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Ceftriaxone 2 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Deferoxamine 3300 mg/20 mL Sterile Water for Injection syringe, FOR SUBCUTANEOUS USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Vancomycin 500 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Nafcillin 3 grams in 277 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Invanz 1 gram Add-Vantage in 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Vancomycin 1500 mg in 270 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Piperacillin-Tazobactam 9 grams/NS 302 mL bags, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Ertapenem 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bag, FOR IV USE ONLY, Baptist Health Medical Towers Pharmacy & Infusion, Little Rock, AR
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
AK, AL, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC,  ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, Australia, Puerto Rico
Life's Qik Fix 70 Plant Minerals Plus 80 Additional Nutrients 180 Vegetable Capsules Dietary Supplement Manufactured Exclusively For: MAGZUMA NUTRITION Overland Park, Kansas 66210 www.magzuma.com 1-888-306-8855 or 1-913-624-9676
Dietary Supplements contain undeclared milk and soy.
Angel Wings Complete Daily Multi with 146 nutrients including Anti-aging and Superfruit Antioxidants and 75 Plant Derived Minerals 120 Capsules UPC: 0-16158-01225-3 Liquid Assets, Inc. Tulsa, OK 74116 1-888-497-4535 www.ExceptionalProducts.org; Magzuma Zuma Supreme Daily Wellness 147 Whole Food Nutrients Anti-aging and Superfruit Antioxidants 120 Vegetable Capsules Dietary Supplements, MagZuma, LLC. 7300 W. 110th St., Suite 700 Overland Park, Kansas 66210 TEL: 888.306.8855
US: ALL STATES IN CONTINENTAL USA INCLUDING DC AND PR EXCEPT DE.    OUS:  UNITED ARAB EMIRATES, AUSTRIA BELGIUM, CANADA, CHINA, GERMANY, DENMARK, SPAIN, FINLAND, FRANCE, GREAT BRITAIN, HONG KONG, IRELAND, INDIA, ITALY, JAPAN, LUXEMBOURG, MAURITIUS, NEW CALEDONIA, NEW ZEALAND,  PANAMA, PORTUGAL, SAUDI ARABIA, SWEDEN, SINGAPORE, TAIWAN, VIET NAAM, SOUTH AFRICA.
must be removed to activate the Flow Stop.    However, after attaching the reservoir to the pump, the user can still remove the  reservoir from the pump and prime it by holding the Flow Stop in the open position.
Smiths Medical became aware that under delivery of medication may occur on CADD Administration Sets with Flow Stop.
Devices with an expiration date on or before March 2021
U.S. distribution to the following; CA, TX, OR, IA, MN, CO    No foreign distribution.
Pronutri  Re-VITA-lize  Tropical Orange Dietary Supplement  32 oz.
Undeclared whey protein which contains the allergens milk and soy lecithin.
Blood product, which did not meet acceptable product specifications, was distributed.
Blood products, collected from a donor, whose suitability to donate was not adequately determined, were distributed.
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
US: IN, MI, TX.  OUS: GERMANY, FRANCE, ITALY, SWITZERLAND.
Torque Limiting Adapter:  Torque Limiting Attachment, Non Sterile, Distributed by Zimmer.    PRECIMED, Torque Limiting Adaptor, Non Sterile..    Customer Number/Model:  00-2360-080-00   T10232,  T116245   T116245, TLA025-25   TLA025-25,  00-2360-080-05   T10233, MAC21003 T116430, TLA025-30 TLA025-30,  MAC21001   T112972, MAC21001   T13621, TLA025-20   TLA025-20.
Greatbatch Medical has initiated a global Field Recall  for Torque Limiting Devices. Greatbatch identified through laboratory testing that the required sterility assurance level (SAL) of 10-6 is not  achieved on torque limiting devices when subjected to steam sterilization cycles identified in the Instruction  For Use (IFU) provided with the device.
Torque Limiting Handle:  PRECIMED, T-Handle Torque, Non Sterile.    Handle:  Customer Number/Model:  MCL120014   T14000,  TLT911-50-S20   TLT911-50-S20,   TLT911-15-S01   TLT911-15-S01,  TLTS0007-20-S19   TLTS0007-20-S19,   TLT911-35-S01   TLT911-35-S01.
Torque Limiting Screwdriver:    Greatbatch Medical, Torque Limiting Driver, Non Sterile, Rx Only.     PRECIMED, Non Sterile.    Zimmer,  Non Sterile, Rx Only.    Screwdriver:  Customer Number/Model:  804-03-038 T11623, T14001   T14001, MTO35173507   T14378, MTO375173506   T14379, MTO35173505   T14380, MTO35175303   T8127.
Blood and Blood Products for Reprocessing
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Ingenuity Core Computed Tomography X-ray Systems,       Product Usage:  Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
The firm became aware of a problem where the system may not map Varian drive after CT user logout/login.
Ingenuity Computed Tomography X-ray Systems    Product Usage:  Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Brilliance 64 Computed Tomography X-ray Systems    Product Usage:  Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Ingenuity Core 128 Computed Tomography X-ray Systems    Product Usage:  Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Walnut Delights 6 Pack  Net Weight: 9 oz.  PLU #69690  UPC: 2 69690 20399 7  Giant Eagle, LLC, Pittsburgh, PA
Giant Eagle discovered that the scale label fails to declare the milk ingredient. The allergen statement does not declare the milk allergen.
Pecan Tassie - 6 Pack  PLU# 77997  Net Wt. 5 OZ.    Sell By (dates up to) May 03, 2016    Giant Eagle, Inc., Pittsburgh, PA
Small Cookie Tray, PLU # 9793  Net Wt. 45 oz; . and  Medium Cookie Tray, PLU #9794  Net Wt 90 oz.;  and   Large Cookie Tray, PLU #9795  Net Wt. 144 OZ.    Sell by: (dates up to 5/4/2016)    Giant Eagle, Inc., Pittsburgh, PA
Giant Eagle discovered that the ingredient statement for Pecan Tassies fails to declare the milk ingredient. The allergen statement does not declare the milk allergen.
KS, NV, TX, CA, ID, FL, MA, MI, NJ, AZ, NH, SC, UT, WA
Firebird NXG Spinal Fixation System Set Screw Driver used to insert a set screw into a spinal fixation construct.  Rx Only Provided non Sterile.
There is a possibility that the subject set screw driver could disengage from the torque limiting handle when the counter torque wrench is allowed to contact the counter torque handle.
Distributed in the US to the states of AR, CA, DC, MI, MA, MN, NC, NM, NY, PA, SC, TN, TX, WA and WV.
During a recent Ohio site inspection by the FDA it was discovered that warning statements needed to be included with the product shipment.
U.S. distribution to the following; CA, TX, NV, NY, Puerto Rico    Foreign distribution to the following; Canada
New Life  Nature's Blend   100% Multivitamin Juice  32oz.
Undeclared whey protein which contains milk and soy lecithin.
Choice Products.  Xtreme Fiber Detox  Net. Wt. 1lb  Net Wt. 8oz.
Ivory Teff Flour, Bulk 25 lb. bags, is recalled due to a potential contamination with Salmonella.
205782-1026S.  Expiration Date April 11, 2017  Plant Code: B9911
US Nationwide Distribution in the states of: AL, AR, AZ, BC, CA, CO, CT, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN. TX, UT, VA, VT, WA, WI, WV and Puerto Rico
Non-Vented Dispensing Pin with Luer Lock Ultrasite Valve    Product Usage:    Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
11,000 units available in commercial channels
BBMI recently identified a potential for a tear in the outer blister packaging on a limited number of units.  The tears have been identified in the blister package paper, where the unit label writing is located.
Non-Vented Dispensing Pin with One-Way Valve and Luer Lock Ultrasite Valve    Product Usage:  Used for aspiration of medication from inverted bags or semi-rigid containers. Interavenous delivery of transferred medication(Device is not intended for direct infusion)
Approximately 11,000 units available in commercial channels
Fresh Long Chili Peppers, Raw,  10 lb box.  Imported from Dominican Republic.
No lot codes used by recalling firm or grower
Code 2013 Spicy Mac & Cheese Bites Breaded Macaroni & Monterey Jack Cheese O 'Steen Meat Specialties Inc. 2126 N. Broadway Oklahoma City, OK 73103 Phone (405) 236-1952 KEEP FROZEN Net Weight 10 LBS.  UPC: 7-49616-02013-1
distributed in the US including AZ, CA, FL, IL, KS, MA, MD, MN, NC, NH, NY, OH, OK, PA, VA, WA, WA DC,and WI and in Canada and Singapore.
Replacement HEPA filter for Natus Sterile-Drier Model 43 and Model 44.  Filter Catalogue Part Number: 54343, 54344, and 100105-01.
The replacement HEPA Filters have been manufactured with sealant that may not be properly cured. Improperly cured sealant can emit a toxic gas when heated, and can drip down during use, contaminating the interior chamber of the Sterile Drier and its contents.
Product may have been mispackaged and contain undeclared wheat and soy.
Product was shipped to the following states: AL, AR, AZ, CA, CO, GA, ID, IL, IN, KS, KY, LA, MI, MO, MS, MT, NC, NE, NM, NV, OH, SC, TN, TX, UT, VA, WV & WY.
Kroger CRANBERRY DELIGHT TRAIL MIX NET WT 14 OZ  INGREDIENTS: DRIED CRANBERRIES ***ALMONDS, SUNFLOWER SEEDS*** UPC 0 11110 89869 2 DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202
The firm was notified by their supplier that the product may be contaminated with Listeria monocytogenes.
Kroger SALAD TOPPERS Roasted & Salted Sunflower Kernels NET WT 3.5 OZ (99G) INGREDIENTS: SUNFLOWER KERNELS, COTTONSEED AND/OR SUNFLOWER OILS, SALT DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202 UPC 0 11110 02127 4
Kroger SALTED SUNFLOWER KERNELS 6 oz (170g) INGREDIENTS: SUNFLOWER KERNELS, COTTONSEED AND/OR SUNFLOWER OILS, SALT. DISTRIBUTED BY THE KROGER CO CINCINNATI, OHIO 45202 UPC 0 11110 61877 1
Worldwide distribution. US nationwide, Mexico, and Korea.
Miltex Premium Grade Self-Lock Chisel Blade Handle, Catalogue No. 4-405, manual surgical instrument.
One lot of self-lock chisel blade handles have a wider slot that holds the chisel blade that may result in the inability to firmly secure the blade in the handle.
Sulfacetamide Sodium Ophthalmic Solution, USP, 10%, Sterile, Rx Only, 15 mL bottles, Mfd. by: Akorn, Inc., Lake Forest, IL 60045 --- NDC 17478-221-12
Lack of Assurance of Sterility; some lots failed Antimicrobial Effectiveness Testing on stability
Lot# 5A17A, Expiry 06/16  Lot# 5K21A, Expiry 03/17  Lot# 6A08A, Expiry 06/17
Nationwide Distribution to AL, AZ, CO, IA, WI, PA, TN, MA, TX, MI, FL, MS, LA, and CA.
Model number 3502.  All units.  Units entered commercial distribution between April 30, 2014 and July 24, 2014
Distributed US (nationwide) including Puerto Rico and in the Bahamas, Canada, and Singapore.
COSEAL Surgical Sealant Kit, 8 mL, Product Code: 934072;  For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Potential for incomplete dissolution of the polyethylene glycol (PEG) component during the reconstitution of the product, which may affect the consistency of the hydrogel formation during use.
COSEAL Surgical Sealant Kit, 2 mL, Product Code: 934070; For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
COSEAL Surgical Sealant Kit, 4 mL, Product Code: 934071;  For use in vascular reconstructions to achieve adjunctive hemostasis by mechanically sealing areas of leakage.
Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, GA, IL, IN, KY, MI, MN, MO, MT, NV, NH, NJ, NY, NC, OK, OR, PA, SD, TX, VA, WA, WI, and the countries of: Alger, Antiqua & Barbuda, Argentina, Australia, Austria, Belarus, Botswana, Brazil, Bulgaria, Canada, China, Columbia, Croatia, Cyprus, Czech Republic, Ecuador Egypt, Estonia, France, Germany, Greece, Hong Kong, India, Indonesia, Iran,  Israel, Italy, Japan, Lithuania, Malaysia, Malta, Mexico, Morocco, Nabibia, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Russia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka,Sweden, Switzerland, Thailand, Turkey, United Kingdom, Ukraine, Venezuela, Zimbabwe
Monaco RTP System    Product Usage:  The Monaco system is used to make treatment plans for patients with prescriptions for external beam radiation therapy.
(CFS) checkbox is selected, the Y jaws will snap to the port shape when they should remain where they were defined.
Plasma products, for which donor eligibility determinations were inadequately performed, were distributed.
Worldwide distribution. US, Australia, Austria, Belgium, Chile, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Monaco, Netherlands, Norway, Puerto Rico, Portugal, Qatar, Romania, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, and United Kingdom.
SEAL,IS4000 PORTS,12MM&STAPLER,BOX of 10; Model numbers: 470380-04, 470380-05, 470380-06; Part number:470380.  The da Vinci Xi Surgical System cannula seal is used with the cannula accessory and provides sterile disposable cap for each cannula. When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the instrument is inserted during a surgical procedure.
Potential for particulates in insufflation stopcocks on the da Vinci Xi Surgical System cannula seals. The particulates could be introduced into the cannula  lumen when insufflation is connected during a surgical procedure.
SEAL,IS4000 PORTS,5MM-8MM,BOX of 10; Model numbers: 470361-03, 470361-04, 470361-05, 470361-06; Part number: 470361.  The da Vinci Xi Surgical System cannula sterile single use disposable cap for each cannula . When attached to the cannula, the seal maintains insufflation when the cannula is empty and when the instrument is inserted in the patient during a surgical procedure.
American National Red Cross Southeastern Michigan Region
Apheresis Platelets, Leukocytes Reduced, Irradiated
Apheresis product, for which the residual white blood cell count testing was not performed, was distributed.