Recalling Firm
American National Red Cross, Penn Jersey Region
American National Red Cross ARC Blood Services N.E. Region
Bausch & Lomb Inc- Greenville Solutions Plant

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
US Nationwide - OR, FL, MA, TX, CO, OK, IL, and MO
Worldwide Distribution -- USA, including the states of AL, CA, FL, GA, IL, IN, KS, LA, ME, MA, MI, MN, MS, MO, NV, NJ, NM, NY, OH, PA, RI, SC, TN, TX, UT, VA, WV, and WI; and countries of Canada, Germany, and Ireland.
Worldwide Distribution - All states in USA. OUS: List not provided at this time.
North Carolina; Arizona; New Jersey; California; Oklahoma
Worldwide Distribution-USA (nationwide) and the countries of Austria Belgium Bulgaria Cyprus Czech Republic Denmark Estonia Finland Finland France Fren.Polynesia Germany Great Britain Greece Guadeloupe Hungary Iceland Ireland Israel Italy Latvia Lithuania Luxembourg Malta Martinique Netherlands Norway Poland Portugal Qatar Reunion Romania Russian Fed. Serbia Slovakia Slovenia Spain Sweden Switzerland Turkey Unit.Arab Emir.
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Canada, China, EU, Mexico, Russia, Singapore, South Africa, South Korea, Taiwan and United Arab Emirates.
Western Oregon and 1 consignee in Washington
Worldwide Distribution-USA (nationwide) and the countries of Japan, China, Germany, Australia, Thailand, Sri Lanka, South Africa, UAE, Saudi Arabia, Korea, and Taiwan.
Nationwide Distribution including DC and VA.
The product was distributed to AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, KS, KY, LA, MA, MD, ME, MT, NC, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI AND WV.
Distribution US nationwide, including Michigan and a distributor in Colorado.
Worldwide Distrubution ; USA INCLUDING CA, NY, GA, NC, AL, NJ, CT, WA, NY, LA, Il, MA and Internationally to China, Australia, Canada, France, Great Britain, Hong Kong, Thailand, Singapore,and Brazil.
Product was shipped to the following states: AL, AR, GA, IL, IN, KY, MI, MS, MO, OH, SC, TN & WV.
Worldwide Distribution - USA Nationwide in the states of NM, ND, RI, and VT and the countries of Australia, Singapore, Thailand, Central and Eastern Europe, Western Europe, Middle East, & Panama.
Worldwide Distribution - USA (Nationwide) and Internationally to Panama and Singapore.
Distributed to all Wegmans stores in 6 states: MA, MD, NJ, NY, PA, VA
FL, GA, IN, MD, MI, MS, NC, NJ, NY, OH, PA, SC, TN, TX, VA and Puerto Rico
US Nationwide Distribution - AL, AZ, AR, CA, CO, FL, GA, ID, IN, IA, KS, KY, LA, MA, MI, MN, MS, MO, MT, NH, NJ, NM, NY,NC, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VA, WA, WV, WI.

Product Description
SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Body Fusion Device in spinal fusion surgery. Product Usage: The S-Lift Lock Shaft SI50001 mates with SI50002, Implant Inserter, to aid in securing the implant to the whole implant inserter assembly, SI50000.
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister (NDC 66582-320-30), b) 90 count blister (NDC 66582-320-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister (NDC 66582-321-30), b) 90 count blister (NDC 66582-321-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC 66582-322-30), b) 90 count blister (NDC 66582-322-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 66582-323-30), b) 90 count blister (NDC 66582-323-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889
Cattlyst 50G is a Type A Medicated Article packaged in 50 lb (22.68 kg) multiwall paper bag with protective barrier ply.
ADVIA Centaur XP Immunoassay system, an automated in vitro diagnostic analyzer. Catalog # 078-A011-03 - ADVIA Centaur XP, Catalog # 078-A011R03 - ADVIA Centaur XP refurb.
Nonabsorbable Surgical Suture, U.S.P., Sterile - Do Not Resterilize, Deknatel. Indicated for use in soft tissue approximation.
Teleflex Medical, Research Triangle Park, NC, Braided Polyester Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; Tevdek II, Green Braided PTFE Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP Sterile, Deknatel; Tevdek II, White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Silky II Polydek White Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable surgical Suture, USP, Sterile, Deknatel; Silky II Polydek, Green Braided PTFE, Impregnated Polyester Fiber, Nonabsorbable Surgical Suture, USP, Sterile, Deknatel; Polylene Green Braided Polyester Suture Nonabsorbable surgical Suture, USP, Deknatel; Bard FIXT Braided Polyester, Green PTFE Rx Only, Teleflex Research Triangle Park, NC USA, Assembled in Mexico. Indicated for use in soft tissue approximation.
Teleflex Medical, Research Triangle Park, NC, Polypropylene, Rx Only, Sterile, Distributed by Boston Scientific, Natick, MA; CAPIO Green Braided Coated Polyglycolic Acid Suture, Synthetic Absorbable Surgical Suture SUP, RX Only, Teleflex; Deklene II Polypropylene Blue Monofil, Blue Monofilament Polypropylene Suture, Nonabsorbable Surgical Suture USP, Deknatel; Deklene MAXX, Blue Monofilament Polypropylene suture Nonabsorbable Surgical Suture USP, Deknatel. Indicated for use in soft tissue approximation.
Fixt Suture Bonded Plus Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture, Sterile, Rx Only, Teleflex Medical. Indicated for use in soft tissue approximation.
Bard Fixt Suture Braided Polyester, Rx Only, Teleflex Medical, Research Triangle Park, NC USA Assembled in Mexico. Indicated for use in soft tissue approximation.
Deknatel Teleflex Medical Stainless Steel 2 (metric 5) Monofilament Stainless Steel Suture, Nonabsorbable Surgical Suture, U.S.P. Used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.
Deknatel Teleflex Medical Silk Black Braided Silk Suture Nonabsorbable Surgical Suture U.S.P. Indicated for use in soft tissue approximation.
Medtronic SynchroMed II Implantable Drug Infusion Pump, Model 8637-20, 8637-40. The implantable Medtronic SynchroMed II programmable pumps are part of an infusion system that stores and delivers a prescribed drug to a specific site. The implanted infusion system consists of a SynchroMed II pump and a catheter.
Metformin Hydrochloride Tablets USP 500 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134 NDC 24658-290-05
Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134, NDC 24658-0292-05
Blood and Blood Products for Reprocessing
Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 10310308 (100 tests) Cat No. 00203473 SMN 10331250 (Ref) (500 tests) Cat No. 09132781 SMN 10340209 (Ref) (2500 tests) For in vitro diagnostic use in the quantitative determination of folate in serum or red blood cells using the ADVIA Centaur and ADVIA Centaur XP systems
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 762 ( 76 '' bed w/ 2 motors); 763 (3 motors); 763 A ( 3 motors, autocontour) 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 799, 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
RetractaBed , Clinical Contour, Med - Mizer Inc..... Model SS 801, 802, 803, 803A: 80 '' bed with 1, 2, or 3, motors and autocontour 120 V, ...Max Safe Working Load 450 LBS. Acute/Longterm Care AC Powered Adjustable Bed for geriatric care.
Red Blood Cells (Apheresis) Leukocytes Reduced
Alere Triage BNP Test For the Beckman Coulter Access Family of Immunoassay Systems, Model Number 98200, Lot Numbers: 329599, 331265. The Alere Triage BNP test is a two-site immunoenzymatic (sandwich) assay. A sample is added to a reaction vessel with mouse monoclonal anti-human BNP antibody-alkaline phosphatase conjugate and paramagnetic particles coated with mouse Omniclonal anti-human BNP antibody. BNP in human plasma binds to the immobilized anti-BNP on the solid phase, while the mouse anti-BNP conjugate reacts specifically with bound BNP. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. A chemiluminescent substrate, Lumi- Phos* 530, is added to the reaction vessel and light generated by the reaction is measured with a luminometer. The light production is directly proportional to the concentration of BNP in the sample. The amount of analyte in the sample is determined from a stored, multi-point calibration curve. The Alere TriageR BNP test is intended for use with the Beckman Coulter Access Family of Immunoassay Systems for the In Vitro quantitative measurement of B-type natriuretic peptide (BNP) in plasma specimens using EDTA as the anticoagulant. The test is intended to be used for the following indications: as an aid in the diagnosis of congestive heart failure (also referred to as heart failure) as an aid in the assessment of severity of congestive heart failure for the risk stratification of patients with acute coronary syndromes for the risk stratification of patients with heart failure
the BREAD STOP Country White Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
the BREAD STOP Amaranth 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
the BREAD STOP Oatmeal Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
the BREAD STOP Honey Wheat Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
the BREAD STOP Sourdough Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
the BREAD STOP Wheat Sourdough 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
the BREAD STOP Flaxseed Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
the BREAD STOP Spelt and Millet Bread 24 oz. The bread is packaged in a plastic bag and twist tie, with the label inside the bag.
Shimadzu Digital Radiography X-Ray System, Catalog No. DAR-8000f. This device is intended to be used for radiography in the hospital with X-ray devices.
Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25
Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11
CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 30-count bottle, Rx only, Manufactured by: Wockhardt Limited, Mumbai, India; Distributed by: Wockhardt USA LLC., 20 Waterview Blvd., Parsippany, NJ 07054, USA; NDC 64679-735-09, UPC 3 64679 73509 1.
INOmax DSIR, model 10007, Nitric Oxide Delivery System, with Software version 3.0.0. The INOmax DS delivery system delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and a comprehensive alarm system. The primary targeted clinical setting is the Neonatal Intensive Care Unit (NICU) and secondary targeted clinical setting is the transport of neonates.
Bissinger's Dark Chocolate Bunny Ears, 1 oz, individually wrapped in clear plastic with an ingredient card insert and packaged in a 24-ct. ''point of purchase'' display case. UPC 846107009785 (individual unit UPC 846107009788) Product number 16593. Bissinger's Handcrafted Chocolatier, St. Louis, MO.
AlloFuse DBM Putty 5cc, Catalog No. 90038005 AlloFuse is indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloFuse is indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender.
Archer Farms Brand Chocolate Hazelnut Swirl Gelato (Italian Ice Cream), 30 FL OZ. plastic tub, frozen. Product of Italy UPC 085239-703618
Variant II beta-thalassemia Short Program Model Numbers 270-2103 (250 tests) and 270-2154 (500 tests), Bio-Rad Laboratories, Inc. in vitro diagnostic. The Variant II Hemoglobin testing system uses the principals of high performance liquid chromatography (HPLC) for the separation and determination of normal and abnormal hemoglobin.
PRIVATE SELECTION SWEET STRAWBERRY SORBET, Labeled in part: ''INGREDIENTS: WATER, SUGAR***DISTRIBUTED BY, THE KROGER CO., CINCINNATI, OHIO 45232***SELL BY AUG 11 15 3948 00:48 LIA'' 0 11110 52108 8
Refill Kit 8551/856X (includes Models 8561, 8562 and 8564) for use with Medtronic Implantable Programmable Infusion Pumps. Product Usage: The Refill Kits are intended for use in refilling Medtronic programmable, implantable infusion pumps with the exception of Medtronic MiniMed infusion pumps.
Product Brand Name: Alere INRatio2 PT/INR Professional Test Strips Model Number: 99008G2 Product Usage: Usage: Indications for use: The Alere INRatio2 PT/INR Monitoring System (Professional Use), consisting of the INRatio2 Monitor and INRatio2 PT/INR test strip, is used for quantitative determination of international normalized ratio (INR) in fresh, capillary whole blood to monitor the effect of warfarin therapy on clotting time by health care professionals. The Alere INRatio2 PT/INR Monitoring System (Professional Use) is intended for use outside of the body (in vitro diagnostic use). The Alere INRatio2 PT/INR Monitoring System (Professional Use) is not intended to be used for screening purposes. Limitations: The Alere INRatio2 PT/INR Monitoring System (Professional Use) is not intended for use in patients who are transitioning from heparin treatment to warfarin therapy.
12-Instrument Sterilization Tray; Product Usage: The 12-Instrument Tray is used to hold and protect surgical instruments during the sterilization process. Specifically, this tray is used for the Conquest Manual Instrument line. The tray consists of an interlocking tray and lid which are perforated to allow for the passage of sterilizing agent from outside the tray to the inside of the tray where the devices are held. The tray features silicon device holders that secure devices during the sterilization process.
Giraffe Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
Panda iRes Infant Warmers integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
Panda Freestanding Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
Panda Wall-Mount Infant Warmers, integrated with Nellcor SpO2. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
Nellcor SpO2 Upgrade kit, consists of a Nellcor SpO2 circuit board, an OEM part manufactured by a third party supplier; and an integral component of the Nellcor SpO2 device. Controlled infrared heat to neonates who are unable to thermo-regulate based on their own physiology with integrated monitoring feature used for continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (measured by a SpO2 sensor).
TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue.
Scale label printed with ''EASTER BREAD NET WT 17oz (1.06lb)'' UPC 0 77890 32431 8, packaged in clear plastic bag
Joseph Lamelas Atrial Lift System, Model Number MI-ALS-001. A single surgical instrument or tool for retraction of the atrial wall tissue in cardiac surgery.
Bausch & Lomb, Biotrue, Multi-purpose contact lens solution, 10 fl.oz., Sterile.
Medline Skintegrity Moisturizing Lotion, made with oatmeal, aloe & vitamin e, 2 & 4 oz btls, Manufactured in USA for Medline Industries, Inc., Mundelein, IL 60060 UPC 0 80196 75401 7
Verdex Fresh Snow Peas packed in 10 pounds cartons, keep refrigerated, Lot # 2161100811 product from Guatemala
Mar Cor Purification, Central Water Platform (CWP), 102, 104 and 106. Product Usage: The CWP is a Central reverse osmosis system with the intended use of producing water for dialysis of multiple patients.
Mangiacotti - Lemon Verbena Hand Sanitizer Spray, alcohol free, 0.5 fl. Oz., 15 mL spray bottle, UPC 870678005306, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703.
Mangiacotti - Lavender Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005313, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703 .
Mangiacotti - Ocean Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005320, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
Mangiacotti - Clementine Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005337, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
Mangiacotti - Pomegranate Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005344, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.
Mangiacotti - Ginger Lime Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005351, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.

Code Info
S-Lift Lock Shaft Part number; SI50001 Revisions: A, B Lots: 42613, 2478901R, 42615, 7625701
Lot Number: HC220009; Expiries: October 2015
All serial numbers of Catalog # 078-A011-03 - ADVIA Centaur XP and Catalog # 078-A011R03 - ADVIA Centaur XP refurb.
This Medical Device Correction notification affects all SynchroMed II pumps.
Kit Lots ending in and exp date: 219 Exp. Date 25 March, 2014; 222 Exp Date 12 May, 2014; 224 Exp Date 04 August, 2014; 225 Exp Date 04 August, 2014; 226 Exp Date 12 September, 2014; 227 Exp. Date 06 October, 2014
Model Number: 98200. Lot/Unit Codes: Lot #329599, K329599 (Distributed OUS), 331265 and K331265 (Distributed OUS). Expiration date, or Expected shelf life: 10/31/14 and 12/31/14
This is a small white sticker placed on the outside of the bag containing the bread and represents an expiration date. All product produced prior to April 4, 2014 and date codes 4-10 are being recalled.
Printed on the edge lid code: L13-102 BEST BY: 12OCT2014
Catalog number: 270-2103 (250 tests; Reorder pack lot number: 64005302, Expiration: 4/2015; Catalog number: 270-2154 (500 tests) Reorder pack lot number: 64005207, Expiration: 6/2015; 64004750, Expiration: 11/2015
BS9SEN BS9SES BSAVX8 BSAVX9 BSAW3A BSAY0P BSAY0U BSAY15 BSAY18 BSAY1A BSAY1E BSAY1F BSAY1N BSAY1U BSAY1X BSAY3C BSAY3F BSAY3N BSAY3V BSAY3X BSAY5D BSAY5H BSAY8S BSAY9C BSAY9G BSAY9J BSAY9R BSAYAR BSAYAU BSAYB1 BSAYBW BSAYBX BSAYC3 BSAYC9 BSAYCB BSAYCC BSAYCD BSAYGV BSAYGX BSAYGY BSAYGZ BSAYH0 BSAYH4 BSAYH6 BSAYIG BSAYJC BSAYJD BSAYOW BSAYOZ BSAYPM BSAYPU BSAYR5 BSAYSA BSAYSJ BSB993 BSB9AG BSB9AJ BSB9AR BSB9AX BSB9B9 BSB9BD BSB9BE BSB9BK BSB9D6 BSB9D7 BSB9DB BSB9DE BSB9JK BSB9JU BSB9KG BSB9KU BSB9KY BSB9NW BSB9NX BSB9NY BSB9NZ BSB9P3 BSB9P6 BSB9PA BSB9PE BSB9PG BSB9PK BSB9PL BSB9PR BSB9PY BSB9R0 BSB9R3 BSB9R5 BSB9R7 BSB9R9 BSB9RC BSB9RL BSB9RY BSB9RZ BSB9S2 BSB9S3 BSB9S5 BSB9SJ BSB9SY BSB9SZ BSB9T4 BSB9T8 BSB9TA BSB9TD BSB9TG BSB9TJ BSB9TM BSB9TS bsb9tu BSB9TX BSB9TZ BSB9U1 BSB9X6 BSB9X7 BSB9X8 BSB9X9 BSB9XA BSB9XF BSB9XG BSB9XR BSB9XX BSB9Y6 BSB9Y7 BSB9YB BSBCUJ BSBCUS BSBCV1 BSBCV2 BSBCVB BSBCWP BSBOTA BSBOTE BSBOU2 BSBOU8 BSBPTL BSBXTL BSBXTT BSBXTX BSBXU1 BSBXUO BSCE5J BSCEC4 BSCEC5 BSCEC6 BSCEE5 BSCEEC BSCEED BSCEEF BSCEEH BSCEEJ BSCEEW BSCEHH BSCEHN BSCEHR BSCEHW BSCEHX BSCEHZ BSCEKP BSCEKT BSCEKV BSCM9V BSCMA8 BSCMA9 BSCMAD BSCZPT BSCZPU BSCZPW BSCZPY BSCZR6 BSCZR7 BSCZR9 BSCZRC BSCZRO BSCZRP BSCZRW BSD0B1 BSDOAK BSDOAT BSDOAU BSDOAY BSDOAZ BSEJGJ BSA41K BSAY0K BSAY21 BSAYA0 BSAYBC BSAYBH BSAYBN BSB9PX BSB9RR BSB9SB BSB9TH BSB9SA BSB9AV BSBCV5 BSCZRJ BSCZRY
Lot GK2127 (twin packs), SKU: 623588, GK2131 (twin packs), SKU: 623500, STL2019, (6 pk shelf display containing GK2131, SKU: 629743 and STL2025 (6 pk shelf display containing GK2127), SKU: 629743.

Product Quantity
5,900 units total (1,679 domestically & 4,221 internationally)
1,401 cs/36/2 oz bottles & 78 cs/36/4 oz bottles

Reason for Recall
It has been verified through field use that there are two possible breakages that may occur when using SI50001 Revision D Lock Shaft Inserter, possibly resulting in instrument fragments entering the sterile field: Impact Cap: The impact cap on the Lock Shaft Inserter can shear off under high-impact force during insertion and removal. Pin: The pin used to guide the Lock Shaft Inserter into the mating SI50002 Implant Holder can shear off under high-impact force during insertion and removal.
Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Lot HC220009 was mislabeled with the manufacturing date and the expiration dates inverted.
Instrument Cover Gas Spring failures. Over time, the gas spring may lose its effectiveness and fail to support the cover in its full or partially open position. This may lead to the cover falling.
Product does not meet minimum needle attachment strength requirements; thus, the needle can become detached from the suture during use.
This recall provides important new information regarding overinfusion associated with the Medtronic SynchroMed II Implantable Pump. Overinfusion can result in a life-threatening overdose and can also result in drug withdrawal due to premature emptying of the pump. Due to the low reported rate of occurrence of this issue and the inability to predict which pumps may be at risk, Medtronic is not recommending prophylactic replacement of pumps. This communication is based on information available to date and was developed in collaboration with clinical experts. Medtronic continues to investigate this issue and we are committed to providing updates as more information becomes available.
Defective container: Product distributed without inner seal on bottles.
Blood product, labeled leukoreduced which did not meet the requirements for a leukoreduced product, was distributed.
Blood products, possibly contaminated by air during collection, were distributed.
Blood product, inappropriately stored in one platelet bag instead of two, was distributed.
Serum controls may go out of range low with the ADVIA Centaur Systems Folate assay and a shift in whole blood patient may result with kit lots ending in 219 and 223
All configurations of the SS Retractabed, Clinical Contour, made prior to June 7 2008 may have had insufficient welding on the foot cross tube. This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame. If the weld on the tube breaks, it can lead to bed collapse or the rollers coming out of the channel on the bed preventing bed high/low and contour functionality from occurring.
All configurations of the SS Retractabed, Clinical Contour, made prior to June 7, 2008 may have had insufficient welding on the foot cross tube. This tube is responsible for holding the two support rails together when using the foot side rails and keeps them from separating from the frame. If the weld on the tube breaks, it can lead to bed collapse or the rollers coming out of the channel on the bed preventing bed high/low and contour functionality from occurring.
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
Blood products, collected in a manner that compromised the sterility of the units, were distributed.
Alere San Diego, Inc. initiated recall of Alere Triage BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, Lots 329599 and 331265, because these lots may not recover within range when tested using certain commercially available controls.
An anti-stick spray containing soy lecithin was used during the manufacture of several varieties of bread and soy was not declared as an ingredient on the product labeling.
Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances.
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.
Device with Sample Interference Notes (SIN) enabled not cleared for US marketing.
Failed Dissolution Specifications: failure of dissolution test observed at nine month time point.
An anomaly impacts the monitoring system of INOmax DSIR Plus (software 3.0.0). When the integrated pneumatic backup switch is activated with low or no gas flow through the injector module, an intended NO cell failure alarm will occur. In addition, an unintended NO2 cell failure alarm may also occur. The NO/NO2 cell failure alarms are caused by an average NO/NO2 circuit concentration greater than 200 ppm/25 ppm respectively over a 10 second period.
Milk chocolate bunny ears are packaged in dark chocolate packaging. The ingredient statement does not list milk.
Product contains undeclared peanut protein
There is an issue with the buffers which impacts the quantification of the Hemoglobin F peak. Calibration and Quality control are likely to fail if the affected lots are used.
The firm was notified of the presence of undeclared milk in the product.
Some refill kits in the affected lots may contain an extension tubing set that is occluded and healthcare professionals may be unable to aspirate or fill the SynchroMed pumps. There is no problem with the Lioresal Intrathecal (baclofen injection) contained in the affected drug refill kits. There have been no patient injuries beyond additional needle sticks associated with this issue.
Alere San Diego is initiating a voluntary recall for the Alere INRatio2 PT/INR Professional Test Strips. This action is being initiated as a result of several complaints of patients who had a therapeutic or near-therapeutic INR with the Alere INRatio2 PT/INR Professional Test Strip but a significantly higher INR (outside of therapeutic range) when performed by a central laboratory.
Gravity sterilization parameters provided in the 12 Instrument Sterilization reprocessing guide did not fully consider all worst-case scenarios during validation testing.
Medical device software may be defective and may cause user-set alarm limits to result in false positive or false negative Oxygen saturation and pulse rate alarm notifications to the caregiver.
The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that may occur during transport of the product in extreme cold weather conditions, in conjunction with mechanical impact.
Wegmans Food Markets, Inc. has initiated a voluntary recall of all Wegmans Easter Bread (braided loaf) 17 oz., UPC 0 77890 32431 8 (all code dates) because it contains egg, which are not declared on the label.
The support arm attached with an adhesive to the body of the blade is detaching while attempting to engage the visor component.
Out of specification results for one of the two disinfectants.
Kutol Products Company is voluntarily recalling the affected products as they were found to be out of specification for Aerobic Plate Count and presence of gram negative bacteria. Specification for Aerobic Plate Count is < 100 cfu per gram with results for both affected product lots being Too Numerous To Count (TNTC). Specification for gram negative bacteria is ''negative'' with results for both affected product lots being ''positive'' for gram negative bacteria. The gram negative bacteria was identified as pseudomonas aeruginosa.
Unapproved fungicide residue detected on random sample. Carbendizam at 28 ppb
Mar Cor Purification manufactured Central Water Plant (CWP) reverse osmosis system, models 102, 104 and 106. This correction has been initiated due to a potential situation with a specific lot of the water inlet solenoid valve. The potential exists that the water inlet solenoid valve could cease to function. If this occurs, CWP will stop producing reverse osmosis water.
Recombivax HB, one lot with the potential for a crack to have occurred in the vial, was distributed.
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.