Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16027
Hospira has received reports of Malfunction S205 Backup Battery Failure alarms in Symbiq v3.13 pumps. This issue to an incorrect installation of components on some of the Power Supply Controller (PSC) Boards distributed prior to September 2012. On pumps where incorrect installation of components has occurred, the backup battery power discharges and subsequently, the battery cannot be charged. Because of the battery depletion, or lack of charge, a visual and audible warning alarm, S205, is displayed. An S205 alarm is intended to notify the customer that the coin call battery, powering the backup buzzer, may need to be charged or replaced.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids; Product List Number 16026
Distributed within the United States, Canada, Mexico, Puerto Rico and Columbia
Used for the temporary relief of joint and muscle pain.
Products manufactured with the SPT cord have a known failure mode of sparking,causing smoke, fire and burns.
Whole Foods Market North Atlantic Kitchen
Whole Foods Asparagus Pea & Ricotta Salad, 10 Ounces
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
7-ELEVEN FRESH TO GO CHOCOLATE CHUNK COOKIE, NET WT. 4 OZ., UPC 052548558741; Manhattan UPC: 052548570668 --
The finished cookie product may contain undeclared peanuts.
Best By Dates: Friday 0422, Saturday 0423, Sunday 0424
7-ELEVEN FRESH TO GO SUGAR COOKIE WITH M&M CHOCOLATE CANDY, NET WT. 4 OZ., UPC 052548558765; Manhattan UPC: 052548570644
7-ELEVEN FRESH TO GO OATMEAL RAISIN COOKIE, NET WT. 4 OZ., UPC 052548558758; Manhattan UPC: 052548570651
Frontera Texas Original Taco Skillet Sauce with mild red chile + cumin 8 oz. pouch
Product may have undeclared soy from soy sauce.
VitaTops Apple Crumb, NET WT. 2 oz. (55g), packed in a clear plastic film and sold frozen in cases of 12 units, 24 units, or variety packs.  The affected lots were sold in case of 24 units per case.
The affected lots of VitaTops Apple Crumb contain undeclared milk.
Lots 16 075 C and 16 078 C (stamped on top of film)
US Distribution to the states of : AL, AK, FL, IN, TN & TX
15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415   Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia
1) Spectra Lot# GC091702 (Epimed manufacturing lot # 2801501, Sterile Lot # 12157181)  2) Spectra Lot# GC101871 (Epimed manufacturing lot # 3211503, Sterile Lot # 12157445)  3) Spectra Lot# GC101897 (Epimed manufacturing lot # 3161501, Sterile Lot # 12157325)
Worldwide Distribution - US including CA, IN, PA, and Internationally  to Canada, Korea, and Japan.
Comfort 5+5 Pack w/110cm Tube & 17mm Cann. UPC# 3-89110-14147-7; Comfort 5+5 Pack w/60cm Tube & 17mm Cann. UPC# 3-89110-14127-9; Comfort 5+5 Pack w/110cm Tube & 13mm Cann. UPC# 3-89110-14143-9; Conform 5+5 Pack w/60cm Tube & 13mm Cann. UPC# 3-89110-14123-1  The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
AC TenderLink 13/30 10 pcs; AC TenderLink I 13/60 10 pcs; AC TenderLink I 13/80 10 pcs; AC TenderLink I 17/110 10 pcs; AC TenderLink I 17/30 10 pcs; AC TenderLink I 17/60 10 pcs; AC TenderLink I 17/80 10 pcs; AC TenderLink I 13/110 10 pcs  The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
, Paradigm  The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
US Distribution to: AL, IL, OK, MN, MA and WI.
Affected Pain Control Tray Component (5% Lidocaine Hydrochloride and 7.5% DExtrose Injection, USP)    Injection of anesthetics to provide regional anesthesia
B. Braun Medical Inc. is voluntarily recalling specific lots of their Custom Spinal Anesthesia Tray which contains a drug component, 5% Lidocaine Hydrochloride and 7.5 % Dextrose Injection, USP that Hospira Inc. has recalled because the drug product does not meet the specification for color throughout shelf life.
Product distributed to the following states: AL, CA, CT, FL, IL, LA, MA, MD, MI, NM, NY, OH, OR, TX, WA,  WY. Distributed worldwide to Canada, Colombia, France, Hong Kong.
Balanced Guru Calming Masque, Organic Calendula & Echinacea Facial Masque, 4 oz and 1 oz.
Tested positive for microbial contamination.
Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ  07054, NDC 16252-570-30.
Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
Lot #: 1136091A, Incorrectly Labeled Exp: 03/18
Mindray DS USA, Inc. dba Mindray North America
TD60 display Telemetry Transmitter, SHENZHEN Mindray Bio-Medical Electronics Co., LTD, Mindray Building, Keji 12th Road South, Hi-Tech Industrial Partk, Nanshan, Shenzhen, 518057 P.R. China
Mindray has become aware that the TD60 Display Telemetry Transmitter used with the BeneVision Central Station may crack on the bezel surrounding the display and also the transmitter may not power on or will power on but display an error message.
Glucose Tolerance Beverage- Orange 50 gram Concentration, Liquid 4/Pack of 6 bottles, 24/case  Accessory  to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured glucose load of either 50 grams, 75 grams or 100 grams. After the glucose load is consumed, measurements of blood glucose are drawn at specific time intervals to determine potential defects in insulin secretion and/or insulin action. Insulin is the hormone produced by the pancreas that moves glucose from the bloodstream into cells. 50 gram glucose loads are typically administered for the initial screening of gestational diabetes. 75 gram glucose loads are typically administered for the diagnosis of diabetes mellitus. 100 gram glucose loads are typically administered for the diagnosis of gestational diabetes.
Out of Specification Microbiological test results
Item Number: 10-O-050  Lot Number: 51426  Expiration Date: 05/2018
Fruit Punch Glucose, 100 Gram Concentration, Liquid,  4/Pack of 6 Bottles, 24/cs  Accessory to an In Vitro Diagnostic Oral Glucose Tolerance Test (OGTT) in the evaluation of diabetes mellitus and related disease conditions. Oral Glucose Tolerance Drinks provide a premeasured glucose load of either 50 grams, 75 grams or 100 grams. After the glucose load is consumed, measurements of blood glucose are drawn at specific time intervals to determine potential defects in insulin secretion and/or insulin action. Insulin is the hormone produced by the pancreas that moves glucose from the bloodstream into cells. 50 gram glucose loads are typically administered for the initial screening of gestational diabetes. 75 gram glucose loads are typically administered for the diagnosis of diabetes mellitus. 100 gram glucose loads are typically administered for the diagnosis of gestational diabetes.
Item Number: 10-FP-100  Lot Number: 49936  Expiration Date: 11/2017
Product was distributed to IA, CA, NH, WA, FL, NJ, IL, MA, TX, IN, NY, ND, PA, WI, TN, CO, and MN as well as through internet sales.
Aura Cacia Relaxing Lavender Milk and Oat Bath, packaged in 9.75 oz plastic jars UPC 0-51381-90317-6,1.75 oz foil pouches UPC 0-51381-90307-7, and 49.6 g foil pouches (with Canadian labeling) UPC 0-51381-30307-5, Distributed by Frontier Natural Products Co-op Norway, IA
1221 units (9.75 oz  jars), 8,565 units (1.75 oz. packets)  [American labeling], 815 units (49.6g packets) [Canadian labeling]
Products tested high for microbial contamination.
Worldwide Distribution - US including CA, GA, FL, and TX. Internationally to Australia.
Visualase Visualization Stylets PN 020-2301. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches.  The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile.  The visualization stylet is constructed of titanium and used during Visualase laser ablation procedures by inserting it into intracorporeal catheter lumens for improved catheter stiffness and MRI visualization during procedures
Medtronic Navigation, Inc. announces a voluntary field action for the Visualase Visualization Stylets and Visualase Body Accessory Kit because when the Visualization Stylet is placed in the magnetic field of a magnetic resonance imaging system it pulls and/or bends toward the field.
Visualase Body Accessory Kit PN 020-3000. The individual components within the Visualase Body Accessory Kit are packaged in Tyvek pouches.  The packaged devices are then placed into a cardboard box which is labeled with the Body Accessory Kit label. Labeled sterile.  The visualization stylet is constructed of titanium and used during Visualase laser ablation procedures by inserting it into intracorporeal catheter lumens for improved catheter stiffness and MRI visualization during procedures.
US Distribution to the following states: CA , CO , FL , GA, GA , IL , MA, MA , MD , MI, MO , NC , NE , NJ , NY, NY , OH, OK , PA, TX  and WA.
Rigid Suction Canister 3000 CC and 2000 CC.
Risk of implosion when the Rigid Suction Canister is subjected to excessive negative pressure during use.
RIGID CANISTER 2000 cc and 3000 cc with product code OR220 and OR230. Affected Lot Numbers 9961601xxxx through 9961604xxxx
Product Number 3102071 Ceiling Bracket, Arch 71 White with use on ceiling  installed rail systems: Multirall 200, Likorall 200, 242, 243, 250,  and LikoGuard L and XL.
Ceiling Bracket 71 was  shipped with a larger center hole. A potentially  hazardous situation exists that if the Ceiling Bracket 71  with a larger center hole is used for a concrete ceiling  Ultra System installation with the M8 screw and the safe  working load is exceeded, the system could fall.
manufacturing date between Dec 01, 2015- Apr 14, 2016
Empowr PS Knee System Box Cut Guide;  Used to make the housing resection for the post of the posterior stabilized implant.
It has been discovered that during Empowr PS Total Knee replacement, while chiseling for bone removal in the box area, femoral chipping has occurred in surgery. The current design of the captured box cut guides can create an instance where the surgeon is not fully completing the box cut on the side.
U.S. distribution nationwide.  No foreign distribution
Reprocessed Pressure Tourniquet Cuff (PTC)    Tourniquet cuffs are single- or dual-bladder inflatable cuffs connected to a tourniquet system via a hose assembly. When wrapped around a limb and inflated, tourniquet cuffs apply an adequate amount of pressure on the arterial blood flow in a limb to create a bloodless surgical field.  Tourniquet cuffs are available in a variety of sizes to accommodate a wide range of limb circumferences.
Issue with the process for detection of leaking Pressure Tourniquet Cuffs (PTC). Leaking PTC devices may result in excessive blood loss requiring surgical or medical intervention or systemic leakage of local anesthetic during Bier Block requiring medical intervention.
Heater Cooler Unit    Usage:  The Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.
There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.
HCU 30 Base Unit 100-120 V, Model Number 704629 I 70103.4371  HCU 30 Base Unit Canadian/US, Model Number 705501 I 70103.4653  HCU 30 Base Unit 200-240 V, Model Number 939001 I 70102.8718  All serial numbers are affected.
Nationwide and Australia, Belgium, Canada, China, Cyprus, France, Germany, India, Italy, Japan, Korea, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Singapore, South Africa, Spain, Switzerland, Thailand, Turkey, United Arab Emirates
Some Bipolar shells were manufactured with an out of specification retainer groove.
Wedgewood  Pharmacy Cyclosporine 0.2%  in Corn Oil Ophthalmic Solution 15 ml Drop-Tainers, white LPDE sterile
Routine sterility testing of Cyclosporine 0.2%  in Corn Oil Ophthalmic Solution 15 ml  indicated that the finished ophthalmic solution returned a positive result.
Lot # 000-00731315 Beyond Use Date 02/12/2017 CYCLOS-OPH057VC
Desoximetasone Cream USP, 0.05% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1271-7
Failed Stability Specifications: The subject lots exhibited OOS results for Homogeneity test (Moderate separation).
Desoximetasone Cream USP, 0.25% 100 g, Rx only, mfd. by Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532; NDC 51672-1270-7
Nu-Quench Lime Bar Mix 32 Oz. packaged in plastic bottle, 12 bottles per case
CO, CT, DC, FL, GA, MA, MD, NJ, NY, OH and PA
Select Recipe Buttermilk Ranch Dressing, Net contents: 1 GAL (3.79 L), 4 X 1 GAL
Oasis is recalling several lots of the Select Recipe Buttermilk Ranch Dressing and the Garden Harvest Buttermilk Ranch because they were shipped with an incorrect label not listing Soy Lecithin as an ingredient in the ingredient statement or elsewhere on the display panel.
Garden Harvest Buttermilk Ranch, Net contents: 1 GAL (3.8 L), 4 X 1 GAL.
HANDS-OFF Infusion Port Thermodilution Catheter consists of the Arrow IPTD thermodilution catheter enclosed in a contamination shield (Arrow Cath-Gard) with integral flushing/balloon test chamber, enabling the practitioner to prepare, test, and insert the catheter without exposing it to external contamination.
Red Blood Cells, collected from a donor who was allowed to donate without documentation regarding history of travel to a Zika endemic risk area, were distributed.
Apheresis products, collected from a donor who traveled to a Zika endemic area were distributed.
***HOLLANDAISE SAUSE***Use on chicken, seafood and vegetables***.
Hollandaise Sauce was recalled due to presence of mold.
Texas, Maryland, California, Illinois, and Canada
BELGIAN BOYS MINI PANCAKES, NET WT. 10.6 oz (300g), 36 Count, UPC 857290005204, Product of The Netherlands --- Produced exclusively for Belgian Boys, 140 Carolyn Blvd., Farmingdale, NY 11735
US: 240 cases (12 units per case); Canada: 240 cases (12 units per case)
The product/lot contains undeclared milk.
The product contains undeclared sulfites based on sampling and analysis by New York State Department of Agriculture and Markets and private laboratory testing.
Lot # 20, Production Codes DA:169Z  P:0618 (ink jet printed on the jar lid); Lot # 21, Production Code P:Q0303 (ink jet printed on the jar lid);  Item # 61002 (on case label)
Product distributed to: CT. DE. MA. NH. NJ. NY. PA. RI. VA. and VT.  and online through Amazon.com and Walmart.com
Chocolate Chip Cookie Dough Bar 1.6 oz, 5 count carton
Product may be contaminated with Listeria monocytogenes.
UPC 6 32674 85579 4, Enjoy by Aug 22 2017 and Lot Code NF082216A.
Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.
Subpotent Drug: concentration of product is less than labeled amount.
distributed in AK, AR, CA, CT, MD, NJ, NY, OR, PA, TX, and WA
The Stone Ground Peanut Butter Chocolate Bar, Net wt. 2.5 oz. UPC 8 55966 00107 9.
The Stone Ground Peanut Butter Chocolate Bar is recalled due to undeclared soy lecithin.
The Most Awesome Chocolate Bar Ever, Net wt. 1.5 oz. UPC 8 55966 00178 9.
The Most Awesome Chocolate Bar Ever is recalled due to undeclared wheat.
Blood products, in which donor screening/deferral screening not done or incorrectly performed, including incorrect ID used during search,prior deferral due to testing were distributed.
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 products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed
Colorado and Kansas. No Canadian, VA/govt/military or other foreign consignees.
Organic 2oz Micro Greens. Clear Plastic Clamshell. Keep Refrigerated
Osage Gardens announces a voluntary recall of Organic 2oz Micro Greens due to a positive test for Salmonella.
Worldwide Distribution - US including AK, IL, OH and Internationally to:  ARGENTINA  AUSTRALIA  AUSTRIA  BELGIUM  BRAZIL  CANADA  CHILE  CZECH REPUBLIC  ECUADOR  EGYPT  FRANCE  GERMANY  GREECE  HUNGARY  INDIA  IRAN  ISRAEL  ITALIA  JAPAN  MEXICO  NETHERLANDS  NORWAY  PERU  PHILIPPINES  POLAND  RUSSIA  SERBIA  SINGAPORE  SLOVAKIA  SOUTH AFRICA  SOUTH KOREA  SPAIN  SWEDEN  SWITZERLAND  THAILAND  TUNISIA  TURKEY  UK  URUGUAY  VIETNAM.
Guider Softip XF;  GUIDER/40DEG XF/6FR/90CM, Model number: H965100420.    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.
1478 devices, all models and lot numbers.
Firm became aware of potentially defective Guider Guide Catheters due to a manufacturing non-conformance that could lead to hub leaks in the resulting product.
Guider Softip XF;  GUIDER STRAIGHT XF 5F 100CM, Model number: M003101640.  Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.
Guider Softip XF;  GUIDER MPXF 5F 100CM, Model number: M003101630.    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.
1478 devices, all models and lot numbers
Guider Softip XF;  GUIDER 40XF 5F 90CM, Model number:M003100620 .    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.
Guider Softip XF;  GUIDER/40XF/8FR/90CM, Model number: H965100440 .    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.
Guider Softip XF;  GUIDER/MP XF/6FR/90CM, Model number: H965100460.    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.
Guider Softip XF;  GUIDER/ST XF/6FR/100 cm, Model number:M003101500 .    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.
Guider Softip XF;  GUIDER MPXF 5F 90CM, Model number: M003100630.    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.
Guider Softip XF;  GUIDER/40 DEG XF/6FR/100 cm, Model number: M003101420.    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.
Guider Softip XF;  GUIDER/MP XF/7FR/90CM, Model number: H965100470.    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.
Guider Softip XF;  GUIDER/40DEG XF/7FR/90CM, Model number: H965100430 .    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.
Guider Softip XF;  GUIDER/MP XF/8FR/100 cm, Model number: M003101480.    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.
1478 devices total, all model numbers and lots.
Guider Softip XF;  GUIDER/ST XF/8FR/90CM, Model number: H965100520.    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.
Guider Softip XF;  GUIDER STRAIGHT XF 5F 90CM, Model number: .  M003100640.  Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.
Guider Softip XF;  GUIDER/40 DEG XF/7FR/100 cm, Model number: M003101430 .    Cardiology:   Boston Scientific Guider Softip XF Guide Catheters are intended to facilitate the  placement of interventional devices into the neurovascular system.
Blood products, collected from an unsuitable donor due to a donor screening deviation, were distributed.
Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, Rx only, Manufactured in Canada By:  Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL  35811
Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), Rx only, Manufactured in Canada By:  Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL  35811
Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), Rx only, Manufactured in Canada By:  Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL  35811
Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, 6 blisters (NDC 0603-7609-17), Rx only, Manufactured in Canada By:  Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL  35811
Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), Rx only, Manufactured in Canada By:  Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL  35811
Blood product collected from a donor for whom donor suitability was not adequately determined, was distributed.
West TN Regional Blood Ctr, Inc dba Lifeline Blood Services
Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Worldwide Distribution -- USA, to AL, CA, CT, FL, GA, IA, ID, IL, IN, KY, MI, MN, MS, NC, NE, NJ, NY, OH, OK, PA, RI, SC, SD, TX, VA, WA, WY, and Puerto Rico; and, to the countries of AUSTRALIA, CANADA, CHILE, CZECH REPUBLIC, FRANCE, MEXICO, NETHERLANDS, PANAMA, SAUDI ARABIA, SWITZERLAND, TAIWAN, and UNITED KINGDOM.
Xhibit Central Station, Model 96102.      Intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters.
343 units (287 units in the US and 56 units outside the US)
The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display.  Desaturation, high, and low limit alarms work normally.
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
Apheresis product, in which quality control for residual WBC count was not performed, was distributed.
Aurora Area Blood Bank Dba Heartland Blood Centers
Platelet product, for which quality control and distribution did not meet specifications, was distributed.
Apheresis Red Blood Cells, Leukocytes Reduced
RBC product, for which quality control and distribution of product did not meet specifications, was distributed.
Blood products, collected from a donor who did not have a complete physical examination, were distributed.
Source Plasma, collected from an ineligible donor, was distributed.
Human tissue allograft, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, was distributed.
Apheresis product collected from a donor who traveled to a malaria endemic area, was distributed.
Apheresis product, associated with a unit that was found to contain a leak, was distributed.
Flour Tortillas 12 count, Net Wt. 25oz (732g)
Fanega Mexican Foods is recalling flour tortillas because they contain undeclared wheat.
Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.
Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.