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U.S. Department of Health and Human Services

Enforcement Report - Week of September 2, 2015

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices MiniCap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp. Product Code: 5C4483. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture. Product Code: 5C4483; All Lots Class II Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex. Baxter Healthcare Corp.
Devices MiniCap Extended Life PD Transfer Set (6") with Twist Clamp. Product Code: 5C4482. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture. Product Code: 5C4482; All Lots Class II Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex. Baxter Healthcare Corp.
Devices MiniCap Extended Life PD Transfer Set. Product Code 5C4449. intended for use with Baxter Locking titanium adapter for peritoneal dialysis catheter in disconnect applications and in cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler set juncture. Product Code: 5C4449; All Lots Class II Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex. Baxter Healthcare Corp.
Devices CAPD Solution Transfer Set with Locking Connector. Product Code: 5C4160. intended for use with containers of DIANEAL peritoneal dialysis solution. Product Code: 5C4160; All Lots Class II Labeling Revision: Additional instructions for the use of peritoneal dialysis transfer sets including the sanitization the connection, healthcare provider monitoring of thyroid function, caution against reuse or reprocessing of the devices, warning against use if tip protectors are not in place, and advisement that the product does not contain natural rubber latex. Baxter Healthcare Corp.
Drugs Mucinex Fast Max Cold, Flu & Sore Throat, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, , Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-015-66, UPC 63824-01565-1 Lot #: Exp: MCF0048 7/31/2016 MCF0051 7/31/2016 MCF0052 8/31/2016 MCF0053 8/31/2016 MCF0054 8/31/2016 MCF0055 8/1/2016 MCF0056 8/31/2016 MCF0057 8/31/2016 MCF0058 8/31/2016 MCF0059 10/1/2016 MCF0060 8/31/2016 MCF0061 8/31/2016 MCF0062 8/31/2016 MCF0063 9/30/2016 MCF0064 9/30/2016 MCF0065 9/30/2016 MCF0066 9/30/2016 MCF0067 9/30/2016 MCF0068 9/30/2016 MCF0069 10/31/2016 MCF0070 10/31/2016 MCF0071 10/31/2016 MCF0072 10/31/2016 MCF0073 10/31/2016 MCF0074 10/31/2016 MCF0075 10/31/2016 MCF0076 10/31/2016 MCF0077 10/31/2016 Class I Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. Reckitt Benckiser LLC
Drugs Mucinex Fast Max Night Time Cold & Flu, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Diphenhydramine HCl Antihistamine/Cough Suppressant, Phenylephrine HCl Nasal Decongestant, 6 fl oz. (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-500-66, UPC 63824-50066-09 Lot #: Exp: MNT0003 7/31/2016 MNT0004 7/31/2016 MNT0005 7/31/2016 MNT0006 7/31/2016 MNT0007 7/31/2016 MNT0008 7/31/2016 MNT0009 7/31/2016 MNT0010 7/31/2016 MNT0011 7/31/2016 MNT0012 7/31/2016 MNT0013 7/31/2016 MNT0014 10/31/2016 MNT0015 10/31/2016 MNT0016 10/31/2016 MNT0017 10/31/2016 MNT0018 11/30/2016 MNT0019 11/30/2016 MNT0020 12/31/2016 MNT0021 12/31/2016 MNT0022 12/31/2016 MNT0023 12/31/2016 MNT0024 12/31/2016 MNT0025 12/31/2016 AA037 12/31/2017 AA060 1/31/2017 AA080 1/31/2017 AA097 1/31/2017 Class I Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. Reckitt Benckiser LLC
Drugs Mucinex Fast-Max Cold & Sinus, Maximum Strength, Acetaminophen Pain Reliever/Fever Reducer, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. by: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-016-66, UPC 63824-01665-8 Lot #: Exp: MCS0019 7/31/2016 MCS0020 7/31/2016 MCS0021 7/31/2016 MCS0022 8/31/2016 MCS0023 8/31/2016 MCS0024 9/30/2016 MCS0025 9/30/2016 MCS0026 9/30/2016 MCS0027 11/30/2016 MCS0028 10/31/2016 MCS0029 10/31/2016 MCS0030 12/31/2016 MCS0031 12/31/2016 MCS0032 12/31/2016 MCS0033 12/31/2016 Class I Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. Reckitt Benckiser LLC
Drugs Mucinex Fast Max Day Time Severe Cold and Fast-Max Night Time Cold & Flu Two - 6 fl oz (180 mL) bottles Total -12 fl oz (360 mL), For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-526-22 WO00726864 6/30/2016 WO00737979 1/31/2017 WO00740405 1/31/2017 WO00706571 7/31/2016 WO00707442 7/31/2016 WO00707443 7/31/2016 WO00707444 7/31/2016 WO00707822 7/31/2016 WO00709953 7/31/2016 WO00709955 6/30/2016 WO00720780 7/31/2016 WO00721052 7/31/2016 WO00721170 7/31/2016 WO00721171 7/31/2016 WO00726865 7/31/2016 WO00728864 7/31/2016 WO00728865 12/31/2016 WO00728866 12/31/2016 WO00730003 12/31/2016 WO00730004 12/31/2016 WO00735142 12/31/2016 WO00736753 12/31/2016 WO00737477 1/31/2017 WO00738556 12/31/2016 WO00739050 12/31/2016 WO00740406 1/31/2017 Class I Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. Reckitt Benckiser LLC
Drugs Mucinex Fast Max Severe Congestion & Cough, Maximum Strength, Dextromethorphan HBr Cough Suppressant, Guaifenesin Expectorant, Phenylephrine HCl Nasal Decongestant, 6 fl oz (180 mL) Bottle, For Age 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-014-66, UPC 6382401465-4 Lot #: Exp: MSC0049 8/31/2016 MSC0050 8/31/2016 MSC0051 8/31/2016 MSC0052 8/31/2016 MSC0053 8/31/2016 MSC0054 8/31/2016 MSC0055 8/31/2016 MSC0056 9/30/2016 MSC0057 9/30/2016 MSC0058 9/30/2016 MSC0059 10/31/2016 MSC0060 10/31/2016 MSC0061 10/31/2016 MSC0062 10/31/2016 MSC0063 10/31/2016 MSC0064 10/31/2016 MSC0065 10/31/2016 MSC0066 10/30/2016 MSC0067 11/30/2016 MSC0068 11/30/2016 MSC0069 11/30/2016 MSC0070 11/30/2016 MSC0071 11/30/2016 MSC0073 11/30/2016 MSC0074 11/30/2016 MSC0075 11/30/2016 MSC0076 11/30/2016 MSC0077 12/31/2016 MSC0078 12/31/2016 MSC0079 12/31/2016 MSC0080 12/31/2016 MSC0082 12/31/2016 Class I Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. Reckitt Benckiser LLC
Drugs Mucinex Fast Max Day Time Severe Congestion & Cough Night Time Cold & Flu, Maximum Strength, Two - 6 fl oz (180 mL) bottles Total - 12 fl oz (360 mL), For Ages 12+, Dist. by Reckitt Benckiser Parsippany, NJ 07054-0224, Made in India, NDC 63824-528-22-01, NDC 63824-528-22-00, UPC 63824-52822-9 Lot #: Exp: WO00707825 5/31/2016 WO00713226 7/31/2016 WO00715310 6/30/2016 WO00715505 7/31/2016 WO00721174 9/30/2016 WO00721177 10/31/2016 WO00726860 10/31/2016 WO00726862 6/30/2016 WO00726952 8/31/2016 WO00728861 6/30/2016 WO00728878 7/31/2016 WO00728879 9/30/2016 Class I Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. Reckitt Benckiser LLC
Drugs Mucinex Fast Max DM Max, Maximum Strength, Dextromethorphan HBr Cough Suppressant, 6 fl oz (180 mL) Bottle, For Ages 12+, Dist. By: Reckitt Benckiser Parsippany, NJ 07054-0224 Made in India, NDC 63824-019-66, UPC 63824-01966-9, UPC 63824-52622-5 Lot # : Exp: AA189 1/31/2017 MDM0036 9/30/2016 MDM0039 11/30/2016 MDM0042 11/30/2016 MDM0043 11/30/2016 MDM0044 11/30/2016 MDM0045 11/30/2016 MDM0046 11/30/2016 MDM0047 11/30/2016 MDM0048 11/30/2016 MDM0049 12/31/2016 MDM0050 12/31/2016 MDM0052 12/31/2016 MDM0053 12/31/2016 Class II Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing. Reckitt Benckiser LLC
Biologics Red Blood Cells Leukocytes Reduced W20221524619200M, W20221524619800A, W202215246207003, W20221524621000D, W20221525223800L, W20221525224000X, W20221525224200T, W20221525224600L, W20221524399000A, W202215257506007, W20221525900200N, W20221525900500H, W20221525900800B, W20221525901200J, W20221525902000J, W20221525902100H, W20221525134500V, W20221525135100Z, W20221525135900J, W20221525136100V, W20221525136900F, W20221525137300N, W20221524678000J, W202215246787005, W20221524679000F, W20221524679200B, W20221524679800*, W202215246439008, W20221524644400E, W202215246447008, W202215246448006, W20221524645200E, W20221524645400A, W202215246467000, W20221524683000V, W20221524683300P, W20221524683600J, W20221524683800F, W20221524684100P, W20221527509300M, W20221527509800C, W20221527510100H, W20221527510400B, W202215275107005, W20221525613400A, W202215256136006, W202215258154007, W202215258172003, W20221525818500U, W20221525819200W,  ...
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Class II Blood products, collected in a manner lacking assurance of sterility, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma W20221524061900M W20221524062000 W20221524321600C W20221525472600V W20221525473400V W20221525474300T W202215246231003 W20221524623900O W20221524399000A W20221524678000J W20221524679200B W20221524679800 W20221524645200E W20221524683300P W20221524683300P W20221524683300P W20221524683300P W202215258154007 W202215258172003 W20221525818500U W20221525820000R W20221525820500H W20221527808100J W202215275518004 W202215275525006 W202215278246009 W202215260294005 W20221527846000Y W20221527846400Q W20221528700900J W20221528704400D W20221527475700R W20221527476200X W20221528459500 Class II Blood products, collected in a manner lacking assurance of sterility, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated W202215278086009 W20221527554500Z Class II Blood products, collected in a manner lacking assurance of sterility, were distributed. American National Red Cross (The)
Biologics Plasma Frozen within 24 hours (FP24) W20221524562700G W202215245647008 W20221523908500C W20221524060700U W20221524061300Y W20221524061600S W20221524322100I W20221524323900Z W202215257506007 W20221525901200J W20221525902000J W20221525902100H W20221525134500V W20221525135900J W202215246439008 W20221524683600J W20221527509800C W20221527510100H W202215275107005 W20221525613400A W202215256136006 W202215258235005 W20221527809300B W20221527554500Z W20221527554800T W20221527555600T W202215278166009 W20221527827700W W20221527833200D W20221527835500* W20221526025900B W20221527845500S W20221528701500N W202215274752000 W20221528461700J W20221528426500Z Class II Blood products, collected in a manner lacking assurance of sterility, were distributed. American National Red Cross (The)
Biologics Platelets Pooled Leukocytes Reduced W20221528035600J Class II Blood products, collected in a manner lacking assurance of sterility, were distributed. American National Red Cross (The)
Devices PTW UNIDOS webline: 1) REF T10023, 2) REF T10022 and 3) REF T10023 Firmware version 2.05. Dosimeter for radiation therapy, diagnostic radiology and health physics. serial numbers: **T10021: 000005, 000019, 000037, 000041, 000047, 000049, 000058, 000066, 000074, 000076, 000079, 000099, 000107, 000125, 000141, 000144, 000158, 000161, 000168, 000175, 000186, 000212, 000221, 000224, 000229, 000231, 000254, 000262, 000274, 000294, 000301, 000302, 000327, 000351, 000352, 000382, 000401, 000413, 000424, 000437, 000445, 000452, 000470, 000477, 000486, 000504, 000525,  ...
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Class II In some cases, especially with high dose-per-pulse-rates typical for particle (specifically proton) therapy, measuring errors can result. Individual measurement intervals can be lost that are not visible to the user when there is a high dose-per-pulse rate resulting in a too-low dose being displayed on the monitor. This could result in a radiation over-exposure. PTW-Freiburg
Food Rato Bhale Nepali Finger Chips Product of Nepal Weight: 200g (7.05 OZ) Imported by: Balajee Trade Link, LLC, PA USA Batch No. 01-15 On bag Batch No. 01-15 Class II Nepali Finger Chips contains undeclared tartrazine (yellow #5). Balajee Trade Link LLC
Devices RayStation 4.7, version 4.7.1, used with Structure Definition or Automatic Breast Planning. Radiation Therapy Treatment Planning System, for treatment planning and analysis of radiation therapy. software build numbers are 4.7.1.10 Class II Issue with the algorithm for ROI contraction in RayStation 4.7 when non-uniform contraction distances are used. The ROI contraction tool uses six distances as input: right/left, inferior/superior and posterior/anterior. These contraction distances are, in error, pairwise reversed, i.e. right is interpreted as left, inferior is interpreted as superior, and posterior is interpreted as anterior. RAYSEARCH LABORATORIES AB
Devices APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. This acetabular cup is intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. H5-12354: Lots - 20127 and 20167; H5-11356: Lot - 20097 Class II The device may have improper screw hole placement due to inaccurate location of the index line. Omnilife Science Inc.
Devices Offset Femoral Alignment Guide, 2mm x 6°; Product Code: KS 67022 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems Lot Numbers: MM0314R, VA0713, Z1111 Class II The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur. Omnilife Science Inc.
Devices Offset Femoral Alignment Guide 4mm x 6°; Product Code: KS 67024 Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems. Product Usage: The instrumentation has been designed to facilitate bone preparation and implantation of the Apex Knee or Apex Hip Systems Lot Numbers: MM0314R, VA0713, Z1111 Class II The markings on both versions of the OFFSET FEMORAL ALIGNMENT GUIDES are incorrect. Specifically, the markings on the alignment guides are reversed from the intended position that should provide proper alignment for the offset revision stems when used with the femur. Omnilife Science Inc.
Devices SEDASYS® Computer-Assisted Personalized Sedation System, SEDPRU01. An integrated physiological monitoring and drug delivery system intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures. Intended to provide physician-led teams with a means of administering 1% propofol (10 mg/mL) injectable emulsion to sedate patients > 18 (ASA I-II) undergoing esophagogastroduodenoscopy (EGD) and colonoscopy procedures. Model #SEDPRU01 Class I Ethicon has found that disinfecting methods not specified in the Instructions For Use (IFU) have led to the degradation of the plastic material of the SEDASYS System Control Unit. Ethicon Endo-Surgery Inc
Devices Wheel caster set screw for Ferno iNX Wheeled Stretcher. Ferno iNX Wheeled Stretcher for pre-hospital patient transport. Serial #s: 15F001703, 15F001704, 15F001705, 15F001706, 15F001707, 15F001708, 15F001709, 15F001710, 15F001711, 15F001712, 15F001713, 15F001714, 15F001715, 15F001716, 15F001717, 15F001719, 15F001720, 15F001721, 15F001722, 15F001723, 15F001724, 15F001725, 15F001726, 15F001727, 15F001729 & 15F001730. Class II The firm discovered an improperly installed set screw in one caster arm assembly on a unit in production. The screw assists in preventing the bearing cup on the caster assembly from backing out of the caster arm during use. Ferno-Washington Inc
Drugs Cyanocobalamin 500 mcg/mL Injectable, 1 mL pre-filled syringe, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 05152015@2, Exp 06/29/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/1 mg/10 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 05112015@19, Exp 06/25/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Methylcobalamin 5000 mcg/mL Injectable, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 05152015@4, Exp 06/29/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 9 mg/1 mg/0.1 mg/10 mcg/mL, 2 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 05192015@17, Exp 07/03/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Papaverine/Phentolamine/PGE-1 Injectable, 30 mg/2 mg/20 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 05282015@7, Exp 07/13/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Papaverine/Phentolamine/PGE-1 Injectable, 10 mg/0.6 mg/10 mcg/mL, 2.5 mL vials, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 05112015@3, Exp 06/25/15; 06012015@12, Exp 07/17/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Papaverine/Phentolamine/PGE-1 Injectable, 20.8 mg/1.4 mg/14 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 06042015@9, Exp 07/19/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Vancomycin 25 mg/mL Opthalmic Solution, packaged in a) 10 mL bottle and b) 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: a) 06042015@15, Exp 06/18/15; 06052015@3, Exp 06/19/15; b) 06082015@21, Exp 06/22/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Doxcycline/0.9% NaCl 150 mg/150 mL IV, 150 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 05122015@13, Exp 06/15/15; 05262015@17, 06082015@11, Exp 07/06/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Tobramycin 14 mg/mL Ophthalmic Solution, 15 mL bottle, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 06082015@20, Exp 06/22/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Doxycycline/0.9 % NaCl 100 mg/100 mL IV, 100 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 05142015@21, 05192015@22, 05282015@16, 06022015@18, 06102015@16, Exp 07/06/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs 17-Hydroxyprogesterone 250 mg/mL Injectable, 5 mL multi-dose vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 03182015@8, Exp 07/31/15; 05112015@7, Exp 09/24/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Hydroxocobalamin (Preserved) 10,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 06082015@5, Exp 07/24/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Papervine/Phentolamine/PGE-1 Injectable, 30 mg/0.5 mg/30 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 06022015@5, Exp 07/17/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Doxycycline/0.9% NaCl 150 mg/250 mL IV, 250 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 0513215@12, 05192015@1, 05222015@14, 05222015@15, 05282015@17, 06012015@18, 06022015@19, 06052015@23, Exp 07/06/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Dexamethasone 24 mg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 05012015@1, Exp 06/15/15; 06022015@14, Exp 07/17/15; 06112015@10, Exp 07/26/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Morphine/0.9 % NaCl 1 mg/mL IV, 250 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 06042015@11, Exp 07/19/15; 06102015@3, Exp 07/25/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Glycerin (v/v) 72% Injection, 25 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 05122015@6, Exp 06/26/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Phenol 6% Injectable, 30 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 06032015@16, Exp 07/18/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Methadone 10 mg/mL Injection, 10 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 05012015@5, Exp 06/16/15; 05152015@10, Exp 06/30/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Papaverine/Phentolamine/Atropine/PGE-1 Injectable, 75 mg/2.5 mg/0.1 mg/75 mcg/mL, 2.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 04202015@18, Exp 06/04/15; 05192015@16, Exp 07/03/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Doxycycline/0.9% NaCl 300 mg/500 mL IV, 500 mL bag, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 05142015@20, Exp 07/06/15; 05282015@15, Exp 07/06/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Hydroxocobalamin (Preserved) 1,000 mcg/mL Injectable, 1 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 06102015@15, Exp 07/25/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Lidocaine/Sodium Chloride 0.4%/20% Injectable, 5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 05072015@4, Exp 06/21/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Drugs Methylcobalamin 1,000 mcg/mL Injectable, 1.5 mL vial, Rx only, Liberty Drug Compound Center, 195 Main St., PO Box 267, Chatham, NJ 07928. Lot #: 05072015@7, Exp 06/21/15 Class II Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product. Liberty Drug & Surgical
Biologics Source Plasma LB0510454; LB0509774; Class III Blood products, in which quality control and distribution/failure to quarantine units due to medical history, were distributed. BPL Plasma, Inc.
Biologics Red Blood Cells W020014105408; Class III Blood products, which donor screening/donor record incomplete or incorrect, were distributed. Walter Reed National Military Medical Center
Biologics Fresh Frozen Plasma W020014105408; Class III Blood products, which donor screening/donor record incomplete or incorrect, were distributed. Walter Reed National Military Medical Center
Devices Carepak Sheer Adhesive Bandages 50 Sterile Bandages Assorted Sizes Model #141168; Lots #s 00013359, 00020722 and 00028721. Class II Contain 0.1% Benzalkonium Chloride in the 5/8 bandages inside the assortment which is not listed as an active ingredient in the product label. ASO, LLC
Food Caesar Salad, #5.56 (2,522g) "INGREDIENTS: Romaine Lettuce, Caesar Dressing (Soybean oil, water, distilled vinegar, Romano cheese (pasteurized part skim milk, cheese culture, salt, enzymes),*****" *ALLERGENS** Fish, Milk, Wheat Product #74810 TC 11741319 BEST USED BY: 7/6/15,  ...
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Class I The firm failed to declare the allergen eggs on their labels. Fresh Unlimited Inc
Food Kale Chicken Caesar Pasta Salad, 3.87# (1.757g) INGREDIENTS: COOKED TRI-ROTINI PASTA***CAESAR DRESSING (Soybean Oil, Water, Distilled Vinegar, Romano Cheese*** ALLERGENS: FISH, MILK, SOY, WHEAT 74910 TC 11731319 BEST USED BY: 7/7/15, TC 11752319 BEST USED BY: 7/7/15, TC 11781319 BEST USED BY: 7/10/15, TC 11812319 BEST USED BY: 7/12/15, TC 11822319 BEST USED BY: 7/12/15, TC 11832319 BEST USED BY: 7/15/15, TC 11841319 BEST USED BY: 7/16/15. 74917 TC 11752319 BEST USED BY: 7/7/15, TC  ...
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Class I The firm failed to declare the allergen eggs on their labels. Fresh Unlimited Inc
Food Kale Caesar Pasta Recovery Salad, 3.375# (1530g) INGREDIENTS: COOKED TRI-ROTINI PASTA***CAESAR DRESSING (Soybean Oil, Water, Distilled Vinegar, Romano Cheese*** ALLERGENS: FISH, MILK, WHEAT Product #74916  TC 11752319 BEST USED BY: 7/7/15, TC 11781319 BEST USED BY: 7/10/15, TC 11801319 BEST USED BY: 7/12/15, TC 11812319 BEST USED BY: 7/12/15, TC 11821319 BEST USED BY: 7/12/15, TC 1184319 BEST USED BY: 7/15/15, TC 11872319 BEST USED BY: 7/18/15. Class I The firm failed to declare the allergen eggs on their labels. Fresh Unlimited Inc
Devices OPD-Scan III Refractive Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. Opthalmic: The OPD-Scan III is a diagnostic instrument that is indicated for use for Mapping of refractive error distribution of the eye by measurement and analysis of spherical power, cylindrical power, and cylinder axis. Software versions: 1.00.08 1.05.07 1.10.01, 1.01.02 1.06.02 1.11.02, 1.02.01 1.07.01 1.12.03, 1.03.02 1.08.01 1.13.01, 1.04.03 1.09.01. Class II Software bug was found where there was no difference in Total and Corneal high-order aberrations, but differences were found in Internal high-order aberrations. Nidek Inc
Devices CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266 210813065 210813066 220813066 230813067 270813067 270813068 270813069 280813069 280813070 290813070 021013082 031013082 031013083 031013084 041013084 071013084 071013085 111013090 111013091 141013091 231013091 241013091 241013092 281013093 060114109 070114109 290114001 300114001 300114002 100214003 100214004 110214004 130214004 010414020 010414021 250314017 260314017 260314018 270314018 270314019 310314019 310314020 070514029 120514029 120514030 130514030 140514030 010714048 300614047 020714048 020714049 030714049 090914066 100914066 110914066 110914067 150914067 160914068 170914068 170914069 021014077 231014084 231014085 271014085 271014086 281014086 201114092 211114092 091214099 091214100 150115006 160115006 220115006 220115007 230115007 100215012 110215012 110215013 050515029 050515030 060515030 070515031 Class II Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month shelf life. Advanced Sterilization Products
Drugs Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA Lot #: a) 11957A, Exp 04/2017; b) 11956A, Exp 04/2017 Class III Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station KVK-Tech, Inc.
Devices 0.9% Sodium Chloride Injection, USP, 10mL in 12mL., Single use, Rx only, Sterile Solution. KH04143,exp. 07/2016; KH04145, exp. 08/2016; KH04153, exp. 11/2016; KH04155, exp. 12/2016 Class II Procedures for the acceptance and control of in-process product have not been adequately established. MRP, LLC dba AMUSA
Food Kale Crisps Zen Nori product is seaweed flavored dehydrated kale chip, sold under brand Veggie Evolution, each poly pouch has a net weight 1.5 oz. There are six packages per case. UPC is 7 13757 57480 8. The product's label is read in part: "***VEGGIE EVOLUTION***KALE CRISPS***ZEN NORI***NET WT 1.5 OZ (43g)***INGREDIENTS: KALE, LEMON JUICE, UNREFINED TOASTED SESAME OIL, TAMARI, SESAME SEEDS, ONION, APPLE JUICE, GARLIC,WAKAME SEAWEED, RAISINS***ALLERGEN STATEMENT: MADE IN A FACILITY THAT USES DAIRY PRODUCTS***". Best if Used By dates between 071815 and 022116 The codes represent expiration dates from 07/18/2015 to 02/21/16. Class I Kale Crisps Zen Nori is recalled due to undeclared SOY. Soybean is a sub-ingredient of the ingredient "Tamari" and soy is not declared on label. It Takes A Village Foods, LLC
Food Kale Crisps Lemon Parmesan sold under brand Veggie Evolution, each plastic package has a net weight 1.5 oz. There are six packages per case. UPC is 7 94504 69431 4. The product's label is read in part: "***VEGGIE EVOLUTION***KALE CRISPS***LEMON PARMESAN***INGREDIENTS: KALE, LEMON JUICE, EXTRA VIRGIN OLIVE OIL, PARMESAN CHEESE, FRESH GARLIC, SUNFLOWER SEEDS & SEA SALT***ALLERGEN STATEMENT: MADE IN A FACILITY THAT USES DAIRY PRODUCTS***". Best if Used by Date codes between 071815 and 032716. The codes represent expiration dates from 07/18/2015 to 3/27/16. Class II Kale Crisps Lemon Parmesan is recalled because label declared Parmesan cheese but milk is not declared. It Takes A Village Foods, LLC
Food Vegetable Crisps Lemon Parmesan sold under brand Veggie Evolution, each poly pouch has a net weight 2 oz. There are 6 packages per case. UPC is 7 36211 15015 8. The product's label is read in part: "***VEGGIE EVOLUTION***VEGETABLE CRISPS***LEMON PARMESAN***INGREDIENTS: CARROTS, CABBAGE, ONIONS, LEEKS, KALE, LEMON JUICE, EXTRA VIRGIN OLIVE OIL, APPLE, PARMESAN CHEESE, GARLIC, SUNFLOWER SEEDS, SEA SALT***ALLERGEN STATEMENT: MADE IN A FACILITY THAT USES DAIRY PRODUCTS***". Best if Used by Date codes between 071815 and 032716. The codes represent expiration dates from 07/18/15 and 03/27/16. Class II Vegetable Crisps Lemon Parmesan is recalled because label declared Parmesan cheese but milk is not declared. It Takes A Village Foods, LLC
Biologics Cryoprecipitated AHF, Pooled W137515000052; Class II Blood product, which was labeled with an incorrect expiration date, was distributed. Lane Memorial Blood Bank
Biologics Source Plasma GL0539452; Class II Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed. DCI Biologicals Greenville, Inc
Biologics Red Blood Cells Leukocytes Reduced W051515044099; Class III Blood product, component preparation/component not prepared in accordance with specifications, was distributed. Innovative Blood Resources
Food Vic's All Natural Original White Popcorn, Net Wt. 1-1/8 oz (32g), UPC 46555-00062 Best By Date: 09DEC2015 Manufacture Code: 5195M75 Class I One lot of Vic's Original White Popcorn 1-1/8oz size bags contains an undeclared milk allergen. White Cheddar Popcorn, a product containing milk, was distributed in packaging for a different product, Original White Popcorn. Barrel O' Fun Snack Foods, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036515249586; Class II Blood product, in which donor gave history which warranted deferral or follow up and was not deferred or follow up questions was not asked, was distributed. LifeShare Blood Centers
Biologics Plasma Frozen within 24 hours (FP24) W036215465332; Class II Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed. Belle Bonfils Memorial Blood Center
Devices iChemVELOCITY Automated Urine Chemistry Catalog No. 800-3049, 800-3050, 800-3079, 800-3080, 800-3530, 800-7167, 800-7190, 800-7713,800-7714, 800-7719, 800-7720. An in vitro diagnostic device used to automate the urine chemistry analysis profile using iChemVELOCITY Urine Chemistry Strips. All Serial Numbers Class II Iris International is recalling the iChemVELOCITY systems because they do not maintain the on-board strip stability claim of 5 days at 18-28 degrees celsius at 20-80% relative humidity (RH) as stated in the iChemVELOCITY product labeling. Iris Diagnostics
Devices Covidien Argyle Infant Heel Warmers (no tab) Item Code: MH00002N Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling Lot Codes: 312209X 313033X 313304X 314307X 315108X 318417X 322119X 322514X 322817X Class II Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations Covidien LLC
Devices Covidien Argyle Infant Heel Warmers (with tab) Item Code: MH00002T Product Usage: Intended for application of the right amount of heat to an infants heel for blood sampling. Lot Codes: 309907X 310604X 310704X 312110X 312329X 313034X 313615X 314212X 314308X 317921X 318904X 320714X 320715X 321312X 321423X 321712X 321812X 321826X 321903X 322120X Class II Infant Heel warmers may break during activation resulting in spillage of the contents on patients or healthcare worker causing potential skin/eye irritations Covidien LLC
Devices cobas b 123 Fluid Pack COOX REF 05169992001 200 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COHb, MetHb), and oxygen saturation (SO2). The cobas b 123 POC system calculates derived parameters. Depending on the equipment configuration of the instrument, the Sensor Cartridge and the Fluid Pack used, the following parameters are measured in human whole blood and QC materials. cobas b 123 Fluid Pack COOx Catalog 05169992001, lot numbers 21446113 (exp 8/8/2015), 21446123 (exp 8/18/2015), 21446153 ( exp 9/18/2015), 21446183 (exp 9/19/2015), and 21446203 (exp 10/01/2015) Class II Roche Diagnostics has confirmed an issue causing low PO2 results for patient samples and QC material on the cobas b 123 POC systems. Several customers reported QC failures of the PO2 parameter on cobas b 123 POC systems, affecting primarily Levels 1 and 2. These QC failures are caused by a calibration issue with the PO2 parameter. Detection of this issue is not guaranteed given QC results can be below mean values, but still within 2 standard deviations (SD) limits. There is potential for erroneously low PO2 results in patient samples, especially in blood samples with PO2 values below 50 mmHg. Roche Diagnostics Operations, Inc.
Devices cobas b 123 Fluid Pack COOX REF 05170036001 400 Product Usage: The cobas b 123 POC system is a fully automated POC system for whole blood in vitro measurement of pH, blood gases (B3G), electrolytes NAT, K+, iCaWt (ISE), hematocrit (THct), metabolites (GLu, Lac) total hemoglobin (tHb), hemoglobin derivatives (O2Hb, HHb, COHb, MetHb), and oxygen saturation (SO2). The cobas b 123 POC system calculates derived parameters. Depending on the equipment configuration of the instrument, the Sensor Cartridge and the Fluid Pack used, the following parameters are measured in human whole blood and QC materials. cobas b 123 Fluid Pack COOx Catalog 05170036001, lot numbers 21446113 (exp 9/5/2015), and 21446153( exp 9/24/2015) Class II Roche Diagnostics has confirmed an issue causing low PO2 results for patient samples and QC material on the cobas b 123 POC systems. Several customers reported QC failures of the PO2 parameter on cobas b 123 POC systems, affecting primarily Levels 1 and 2. These QC failures are caused by a calibration issue with the PO2 parameter. Detection of this issue is not guaranteed given QC results can be below mean values, but still within 2 standard deviations (SD) limits. There is potential for erroneously low PO2 results in patient samples, especially in blood samples with PO2 values below 50 mmHg. Roche Diagnostics Operations, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W036514084356 (double collection) Class II Blood products, collected from an ineligible donor, were distributed. LifeShare Blood Centers
Drugs ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva Parenteral Medicines, Inc., Irvine, CA. NDC 073-3019-11 (individual vial), NDC 0703-3019-12 (carton of five). Lot # 31317857B, Exp 08/15 31317859B, Exp 12/15 31317920B, Exp 12/15 31317957B, Exp 12/15 31318136B, Exp 12/15 31318138B, Exp 12/15 Class I Presence of Particulate Matter: silcone rubber and fluorouracil crystals found floating in solution Teva Pharmaceuticals USA
Biologics Source Plasma 2090243321, 2090243656, 2090243967, 2090244272, 2090244643, 2090244952, 2090245302, 2090245588, 2090245980, 2090246261, 2090246630, 2090246935, 2090247202, 2090247529, 2090247795, 2090248485, 2090248782, 2090249198, 2090249499, 2090249960, 2090250276, 2090251022, 2090251444, 2090251749, 2090252490, 2090252727, 2090253192, 2090253417, 2090253829, 2090254035, 2090254462, 2090254694, 2090255155, 2090255365, 2090255863, 2090256113, 2090256577, 2090256819, 2090257299, 2090257556, 2090258048, 2090258330, 2090258867, 2090259153, 2090259723, 2090259988, 2090260517, 2090260779, 2090261341, 2090261608,  ...
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Class II Source Plasma, collected from an inelgible donor, was distributed. Biomat USA, Inc.
Devices HardyCHROM MRSA Cat no: G307 Lot no: H15155 Expires: 2015-08-13 Container Type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage: 2-8C on receipt. Light Sensitive. In Vitro Diagnostic. www.HardyDiagnostics.com Cat no. G307 Lot no. H15155 Class II Hardy Diagnostics is recalling HardyCHROm MRSA due to a report of the potential for breakthrough of the methicillin-sensitive Staphylococcus aureus (MSSA) QC strain, ATCC 29213 on the identified lot. Hardy Diagnostics
Devices Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm Reprocessed by Stryker Sustainability Solutions Product Usage: The Reprocessed Ethicon ENDOPATH® XCEL Universal Trocar Stability Sleeve is a sterile single patient use device with a radiolucent sleeve. The trocar sleeve contains two seals that accommodate instruments 5mm in diameter. Together, these two seals minimize gas leakage when instruments are inserted or withdrawn through the trocar. A stopcock valve is compatible with standard luer lock fitting and provides attachment for gas insufflation and desufflation. The stopcock is in the closed position when it is parallel to the sleeve. Lot number 3574704 UDI Code: (01)00885825014421(17)180310(10)3574704 Model Number: CB5ST (labeled as CB5LT) Class II Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while the devices inside of the packaging were 75mm models (CB5ST). Stryker Sustainability Solutions
Biologics Fresh Frozen Plasma W036815112605, W036815126898, W036815190473 Class III Blood products, which were labeled with the incorrect product type, were distributed. OneBlood, Inc.
Biologics Blood and Blood Products for Reprocessing W036815017741, W036815030668 Class III Blood products, which were labeled with the incorrect product type, were distributed. OneBlood, Inc.
Food Kroger Ground Cinnamon UPC 11110 70034 NEW WT. 18.3 oz Plastic container Sell by: May 19 18PS4 Class I The products were recalled because a container of Kroger Garlic Powder tested positive for Salmonella during routine FDA retail sampling. Out of an abundance of caution, the firm is recalling all items produced on the filling line between sanitation cycles. The Kroger Co
Food Kroger Garlic Powder UPC 11110 70039 NEW WT 24.7 OZ Plastic Container Sell by: May 18 17PS4 Class I The products were recalled because a container of Kroger Garlic Powder tested positive for Salmonella during routine FDA retail sampling. Out of an abundance of caution, the firm is recalling all items produced on the filling line between sanitation cycles. The Kroger Co
Food Kroger Black Pepper Coarse Ground UPC 11110 70041 NET WT 17.1 oz plastic container Sell by: May 18 18PS4 & Sell by: May 19 18PS4 Class I The products were recalled because a container of Kroger Garlic Powder tested positive for Salmonella during routine FDA retail sampling. Out of an abundance of caution, the firm is recalling all items produced on the filling line between sanitation cycles. The Kroger Co
Food Kroger Bac'n Buds ARTIFICIAL BACON FLAVORED CHIPS 14.1oz plastic container UPC 0 11110 70025 4 Sell by: May 20 18PS4 Class I The products were recalled because a container of Kroger Garlic Powder tested positive for Salmonella during routine FDA retail sampling. Out of an abundance of caution, the firm is recalling all items produced on the filling line between sanitation cycles. The Kroger Co
Devices 3.0/4.0 Cannulated Drill Bit; a component of the Tiger Cannulated Screw System The Tiger Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only. Lot 1363-01 Class II The cannulation of the 3.0/4.0 Cannulated Drill Bit inner diamter is too small to allow for the guide wire to pass completely through. Trilliant Surgical Ltd.
Devices Tiger Cannulated Tray Lid Part # 210-00-001-1 NON-STERILE; Combined Tiger/Headless Screw Part # 210-99-101 NON-STERILE; These are components of the Tiger Cannulated Screw System and the Tiger Headless Cannulated Screw System The Tiger Cannulated Screw Fixation System and the Tiger Headless Cannulated Screw Fixation System implants are intended for fixation of fractures, non-unions, arthrodesis and osteotomies of the small bones in the hand and foot. The implants and guide wires are intended for single use only. Lot Numbers ALU120514552473 and 45479 Class II Sterilization tray lids for the Tiger and Tiger Headless Cannulated Screw Systems were reported to occasionally be difficult to remove from the sterilization tray. Trilliant Surgical Ltd.
Devices Concave Reamer Head, 16 mm; Concave Reamer Head, 18 mm; Concave Reamer Head, 20 mm; Concave Reamer Head 22 mm; Convex Reamer Head, 16 mm; Convex Reamer Head, 18 mm; Convex Reamer Head 20 mm; Convex Reamer Head 22 mm, used with Gridlock Plating system, for use in trauma and reconstructive procedures in small bones. TSL000145, TSL000162, TSL000699, TSL000146, TSL000163, TSL000700, TSL00147, TSL000164, TSL000701, TSL000702, TSL000148, TSL000165, TSL000706, TSL000149, TSL000166, TSL000688, TSL000150, TSL000167, TSL000707, TSL000708 Class II The cannulation of the Concave and Convex Reamer Heads may be too small to allow the Guide Pin to freely pass through. Trilliant Surgical Ltd.
Devices Guardian Real-Time Monitor, Model No. CSS7100. Indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the purpose of improving diabetes management. GLU100968U GLU102603U GLU102604U GLU102606U GLU102611U GLU102633U GLU105144U GLU104941U GLU105216U GLU113873U KIT207482U KIT207495U KIT209292U KIT209308U KIT209282U KIT209297U KIT207481U KIT207491U KIT207494U KIT209284U KIT227732U KIT227735U KIT227740U KIT227746U KIT229227U KIT229224U KIT237462U KIT207486U KIT241304U KIT241308U KIT241292U KIT242887U KIT210467U KIT210465U KIT242885U KIT242888U KIT242890U KIT242893U KIT210485U KIT254775U KIT254779U KIT247924U KIT258441U KIT249491U KIT263472U KIT226461U KIT258451U KIT249497U KIT249498U KIT259531U KIT265811U KIT258445U KIT267592U KIT267602U KIT255788U KIT267584U KIT267573U KIT267597U KIT267576U KIT267599U KIT265806U KIT259534U KIT265804U KIT270748U KIT270754U KIT270759U KIT269538U KIT269540U KIT269535U KIT270765U KIT270767U KIT270769U KIT270773U KIT273802U KIT280803U KIT280805U KIT280806U KIT280807U KIT280808U KIT280816U KIT286957U KIT280818U KIT280819U KIT280804U KIT300938U KIT300907U KIT300911U KIT300929U KIT300967U KIT300970U GLU118597U KIT309260U KIT309261U KIT309259U KIT309270U KIT309282U KIT311088U KIT311073U KIT311064U KIT311092U KIT311065U GLU118509U KIT312757U KIT312761U KIT312763U KIT312766U KIT312769U KIT312774U KIT312781U KIT321125U KIT323925U KIT323927U KIT321128U KIT323921U KIT329501U KIT328377U KIT328379U KIT328381U KIT329497U KIT322588U KIT323920U KIT326942U KIT326943U KIT326946U KIT326949U KIT326950U KIT311082U KIT311067U KIT311081U KIT326951U KIT326952U KIT331688U KIT331679U KIT307592U KIT352678U KIT352679U KIT352681U KIT352682U KIT352686U KIT352688U KIT352694U KIT346026U KIT346034U KIT346046U KIT346048U KIT346054U KIT346055U KIT352685U KIT352693U KIT346012U KIT331691U KIT354998U KIT364697U KIT364723U KIT364769U KIT364801U KIT364703U KIT364706U KIT364775U KIT364778U KIT364779U KIT364781U KIT364790U KIT364793U KIT364799U KIT364709U KIT364719U KIT354993U KIT364711U KIT369439U KIT369438U KIT369442U GLU120263U KIT367592U GLU118506U KIT355018U KIT355019U KIT355022U GLU121754U KIT369467U KIT369449U KIT367590U KIT369452U KIT369456U KIT375329U KIT375325U KIT373272U KIT373290U KIT355014U KIT375324U KIT375328U KIT367608U KIT373294U KIT373295U KIT311093U KIT364715U KIT355017U KIT364707U KIT423531U KIT373292U KIT423522U KIT426662U KIT426673U KIT423499U KIT426632U KIT423525U KIT434576U KIT433527U KIT433525U KIT434587U KIT434586U KIT434591U KIT434597U KIT440490U KIT440501U KIT436247U KIT446569U KIT434603U KIT442371U KIT442376U KIT445016U KIT440488U KIT445039U GLU124286U KIT442329U KIT426641U KIT426661U KIT446576U KIT442379U KIT442398U KIT355016U KIT445048U KIT443807U KIT443764U KIT426642U KIT442336U KIT445047U KIT445019U KIT442332U KIT442343U KIT442353U KIT442365U KIT443752U KIT436245U KIT442381U KIT442408U KIT445029U KIT440494U KIT440497U KIT440489U KIT440499U KIT440506U KIT440492U KIT440505U Class II Medtronic MiniMed is recalling the Guardian Real-Time Continuous Glucose Monitoring System because it has a language translation error that impacts the Finnish language. Specifically, the Monitor has a Finnish translation error in Predictive Alerts setting: the on-screen Finnish translation for LOW/HIGH is reversed as HIGH/LOW. Medtronic MiniMed Inc.
Food THE ORIGINAL CHICKEN FRY MIX FROM THE MAKERS OF LOUISIANA BRAND HOT SAUCE, NET WT. 9 oz. (255g), BRUCE FOODS CORPORATION, EL PASO, TEXAS, UPC 1760002733 Lot code: 491162 Class II Products may be contaminated iwth peanut protein. Bruce Foods Corporation
Food LOUISIANA CHICKEN WING SEASONING, HERBS AND SPICES, ADD FLAVOR TO CHICKEN, NET 3.0 OZ (85g), BRUCE FOODS CORPORATION, UPC 1760002153 Lot Code: 49123 Class II Products may be contaminated iwth peanut protein. Bruce Foods Corporation
Food "LOUISIANA" WING KIT containing CHICKEN WING SEASONING, HERBS AND SPICES, ADD FLAVOR TO CHICKEN, NET 3.0 OZ (85g), BRUCE FOODS CORPORATION, UPC 1760002153 (wing seasoning) Kit Code: 191260, Lot Code (CHICKEN WING SEASONING): 49123 Class II Products may be contaminated iwth peanut protein. Bruce Foods Corporation
Biologics Red Blood Cells Leukocytes Reduced W042215008657R Class III Blood product, collected using a shaker device for which the quality control results were not documented, was distributed. Blood Systems, Inc. dba UBS -Coast
Devices BD CD56 PE Cy 7: NCAM16.2 ASR Analyte Specific Reagent, Catalog number 335809 Hematology: The CD 56 antigen promotes homophilic adhesion in neurons and may be involved in homophilic adhesion of NK cells. Catalog number 335809; Lot numbers 4300708, 4304864, 5013643; all with expiry dates of 31 OCT 2015 Class II Three lots of CD56 PE Cy 7, Catalog number 335809, contain a low amount of HLA-DR PE antibody which could result in an unexpected staining pattern. Becton, Dickinson and Company, BD Biosciences
Devices Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position. Model EIZ51, serial number range - ZRS-042132 to ZRS-042157. Class II Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant. Sunrise Medical (US) LLC
Devices Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system with Dynamic Backrest option. Provide mobility to persons limited to a sitting position. Model EIZ4-2, serial number range - IRS-046185-IRS-063437 and IRSE-058994 to IRSE-063928. Class II Quickie IRIS and Zippie IRIS tilt-in-space wheelchairs with MONO Backrest System with Dynamic Backrest may break over time resulting in a fall or injury to occupant. Sunrise Medical (US) LLC
Devices Dimension Vista® ²2-Microglobulin Flex® Reagent Cartridge (B2MIC); Product Usage: The B2MIC method is an in vitro diagnostic test for the quantitative measurement of ²2-Microglobulin in human serum, heparinized plasma, EDTA plasma and urine on the Dimension Vista® System. Measurements of ²2-Microglobulin aid in the diagnosis of active rheumatoid arthritis and kidney disease. Lot Number 15037MA ExpDate 2016-07-14 Class II Customers are receiving a high number of Abnormal Assay Errors or are not able to calibrate B2MIC when using Flex reagent cartridge B2MIC lot 15037MA. In failure mode, there is the potential for falsely depressed beta2-Microglobulin results on the Dimension Vista system due to assay reagent contamination. Siemens Healthcare Diagnostics, Inc.
Devices Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion Part Number: 03.501.080 Lot numbers: 3783492 3783913 3788496 3822332 7516728 7606881 7635218 7653178 7659168 7666085 7671934 7679825 7689244 7694377 7700691 7705157 7720599 7738572 7738573 7740498 7742713 7767497 7797648 7803768 7806881 7818677 7818682 7821672 7827088 7831855 7833606 7858407 8068078 8130898 8130975 8145793 8159386 8166417 8186954 8207769 8209190 8215969 8215999 8241958 8290959 8290968 Class II The end cap may loosen and detach making the instrument non-functional. No injuries reported. Synthes (USA) Products LLC
Devices Philips DigitalDiagnost Release 4.0.3, Release 4.1/4.1.1. excluding systems with SP1 Product Usage: The DigitalDiagnost is intended for use in generating radiographic images of human anatomy by qualified/trained doctors or technicians. DigitalDiagnost Class II The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal due to a defect in the Microsoft Windows 7 operating system. Philips Electronics North America Corporation
Drugs Topicort (desoximetasone) Topical Spray, 0.25%, 100 mL Bottles, Rx Only. Mfd by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada, L6T 1C1, Dist by: TaroPharma, Hawthorne, NY 10532. NDC: 51672-5281-7. Lot #: C4177-14965, Expiry: February 2016; Lot #: C4178-14965, Expiry: February 2016. Class III Failed Impurities/Degradation Specifications: Out of specification results for impurities testing was obtained at the 6 and 9 month time points. Taro Pharmaceuticals, Inc.
Drugs oxyTOCIN 15 Units added to 250 mL 5% Dextrose Injection USP, packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K2677, NDC# 61553-777-02. Lot #: 15041113S, Exp 04/23/15 Class I Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter. Pharmedium Services, LLC
Drugs EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP (4 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6244, NDC# 61553-244-61. Lot #: 15033045S, Exp 05/03/15 Class I Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter. Pharmedium Services, LLC
Drugs HEPARIN Sodium Injection USP, 12,500 USP Units added to 250 mL 5% Dextrose Injection USP (50 units per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K0418, NDC# 61553-418-02. Lot #: 15041123S, 15041003S, Exp 04/16/15 Class I Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter. Pharmedium Services, LLC
Drugs EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP (64 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6618, NDC# 61553-618-61. Lot #: 15033060S, Exp 05/03/15 Class I Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter. Pharmedium Services, LLC
Drugs HEPARIN Sodium Injection USP 25,000 USP Units added to 250 mL 5% Dextrose Injection USP (100 units per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K0419, NDC# 61553-419-02. Lot #: 15041038S, Exp 04/16/15 Class I Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter. Pharmedium Services, LLC
Drugs EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP (16 mcg per mL), packaged in 250 mL bags, Rx only, PharMEDium Services, LLC, 12620 W. Airport Blvd #130, Sugar Land, TX 77478, Service Code 2K6119, NDC# 61553-119-61. Lot #: 15033030S, 15033031S, Exp 04/26/15; 15026051S, Exp 05/03/15 Class I Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter. Pharmedium Services, LLC
Food Fisher Brand chopped walnuts, packaged in 10 ounce, polyethylene stand-up bag with zipper. The bag is blue with white lettering. Best By 3/23/16 HC1 and 3/23/16 HC2 Class I A bag of Fisher Walnuts sampled by the FDA, tested positive for Salmonella. John B. Sanfilippo & Son Inc.
Devices CARESTREAM DRX-EVOLUTION X-Ray System Product Usage: The device is a permanently installed diagnostic X-ray system for general radiographic x-ray imaging including tomography. The tomography feature is not to be used for imaging pediatric patients. Software versions 5.6 and greater and 5.7 (current releases); Serial Numbers: 5029, 5569, 4067, 4754, 4131, 4100, 4096, 4076, 4569, 4570, 4588, 4670, 4767, 4879, 5266, 5393, 5408, 5442, 5572, 5573, 5555, 5556, 5563, 4146, 4679, 4702, 4703, 4704, 4801, 5090, 5154, 4787, 4069, 4074, 4344, 4085, 4058, 4084, 5470,  ...
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Class II Carestream became aware of an issue with its DRX Evolution System v5.7 DIRECTVIEW Software v5.6 and v5.7. It has been determined that there is a software defect that impacts image alignment when using the automatic stitching option for long length images. The defect could cause stitching inconsistencies which may go undetected on a radiograph. Carestream Health Inc
Devices PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound Product Codes: ASK-02041-SEH1 CA-05052-HP CDC-34052-VPS EU-05552-HPMSB ASK-04001-DU4 CA-05052-HPX CDC-35041-VPS FR-04041 ASK-04052-AC CDC-02041-MK1A CDC-35052-VPS FR-04041-CF ASK-05041-LM4 CDC-04041-HPK1A CDC-35541-VPS FR-05041 ASK-05052-SFL CDC-04052-HPK1A CDC-35552-VPS FR-05041-CF ASK-05541-MS2 CDC-05041-HPK1A EU-04041-HP FR-05541-CF ASK-05541-MS3 CDC-05052-HPK1A EU-04041-HPMSB PI-01451-LS ASK-15552-LM2 CDC-05541-HPK1A EU-04052-HPMSB PI-01451-LS5 ASK-15552-MS3 CDC-05542-PK1A EU-05041-HPMSB PK-01451-WS ASK-35041-JHVA CDC-05552-HPK1A EU-05052-HPMSB PK-01451-WSSP CA-05041-HP CDC-15552-HPK1A EU-05541-HP UK-05041-HPMIN CA-05041-HPX CDC-34041-VPS EU-05541-HPMSB lot numbers: 23F14H0517 23F14J0077 23F15F0662 71F14M0678 71F15A1660 23F14L0941 23F15C2282 23F14H0328 71F15A0395 71F15B1938 23F14B1232 23F14D0456 23F14C0598 71F15C0214 71F15D0235 23F15A1523 23F14C0059 23F14F1505 71F15D0053 71F14L1345 23F14A1779 23F14E1213 23F14K1025 71F15D1075 71F15D1077 23F14G1295 23F14G1470 23F15B0400 23F14C0576 71F15E0455 23F14J0973 23F14H1111 23F14F1507 23F14F0115 71F14K1571 23F14M0791 23F14J0613 23F14M0440 23F14G1130 71F14F1786 23F15A1171 23F15A0149 23F14F0364 23F14F0504 71F14G1690 23F14H0848 23F15D0507 23F14L0838 23F14D0713 71F14F1844 23F14F0370 23F14J1512 23F14H0331 23F14C0575 71F14E2043 23F15C2435 23F15C0302 23F15B0401 23F14D0724 71F14K0639 23F14L0090 23F15B0399 23F15D0938 23F14E1493 71F15B1937 23F14G1072 23F14C1096 23F15D0313 23F14F0716 71F14L0577 23F14M0774 23F14H1112 23F14D0281 23F14M1010 71F14L1347 23F15D0622 23F14C0640 23F14E1325 23F15D1420 71F15A1302 23F14H0920 23F14F1497 23F14G0091 71F14H0351 71F15B0662 23F14J1382 23F15A1857 23F14D0282 71F14H0947 71F15D0681 23F15A0038 23F15D0830 23F14H0498 71F14G0365 71F14J1860 23F15C1236 23F14G1471 23F14H1312 71F14H1396 71F14F1785 23F14E1373 23F14M0038 23F14D0285 71F14J0869 71F15A0300 23F14E1124 23F14J1312 23F14B1144 71F14K0082 71F15C2011 23F14F0441 23F15A1604 23F14G0095 71F14F1358 23F14J0437 23F14G1226 23F15B2002 23F14H1314 71F14K0622 23F14K0406 23F15B0065 23F15E1025 23F14E1469 71F14K1332 23F14B0935 23F14J1546 23F14A1419 23F14E1261 71F15A1289 23F14H1535 23F14L0882 23F14C0643 23F14J1390 71F15C1137 23F15A0278 23F15C1237 23F14F1504 23F14E1262 71F15A1984 23F15D0907 23F14H0301 23F14J0221 23F14H0510 71F15B0638 23F14F0326 23F14E1093 23F14J1513 23F14B1128 71F15D0272 23F14K1016 23F14J0415 23F14L1144 23F14C0473 71F15A0152 23F14G1587 23F14B0844 23F14E0791 23F14D0308 71F14M0141 23F15A1813 23F14L0810 23F14E0406 23F14J1391 71F15D1059 23F14D0042 23F14K1361 23F14E1215 23F14F0780 23F14D0217 23F15D0284 23F14M0484 23F14G1458 23F14H0512 23F14D1125 23F14J0358 23F14L0187 23F15D1232 71F14K0081 23F14B1013 23F14F0106 23F15D0881 23F14J0617 71F14J1087 23F14F0510 23F15A0388 23F14J1048 23F14K0537 71F14K0628 71F14K1569 23F15D0046 23F14J0076 23F15A0695 71F14L0323 71F15D0052 71F14G0670 23F15D0882 23F14L1146 71F15D0234 71F14J1086 71F14K1035 23F15F0193 23F15C0992 71F14L0762 71F14H0374 71F14K0409 23F15A0691 71F15B0648 71F14K1198 71F14L1351 Class II the catheter peel-away component hub tabs may prematurely detach. One injury reported. Arrow International Inc
Drugs Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Marketed by: UNICHEM PHARMACEUTICALS (USA), INC. Rochelle Park, NJ 07662, NDC 29300-128-10 Lot #: GHYL15028, Exp April 2018 Class II Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets. Unichem Pharmaceuticals Usa Inc
Devices Synthes Trauma Ex-Fix System (Small, Medium, Distraction Osteogenesis (DO) and Large) ; (S) intended to stabilize and provide treatment for fractures of the small bones, such as the hand, wrist, forearm, foot, and ankle; (M) for the construction of an external fixation frame for the treatment of pediatric and adult fractures; )L) for use to provide treatment for long bone and pelvic fractures that require external fixation; and (DO) for fracture fixation (open and closed),pseudoarthrosis or non-unions of long bones, limb lengthening by epiphyseal or metaphysical distraction, correction of bony or soft tissue deformities and correction of segmental bony or soft tissue defects in adult and pediatric patients. All Lot Numbers of Part Numbers: 390.002 390.003 390.004 390.005 390.007 390.008 390.009 390.010 390.011 390.013 394.79 394.791 394.792 394.793 394.80 394.81 394.82 394.83 394.84 394.85 394.86 394.87 394.88 394.89 394.90 394.91 394.92 03.301.010S 03.301.011S 03.301.012S 03.301.013S 292.40 292.41 390.026 390.027 390.028 390.029 390.030 390.031 390.032 390.033 390.034 390.035 390.036  ...
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Class II Labeling changes were made related to MR conditions that align with standard definitions for MR Safe, MR Conditional, and MR Unsafe. This recall identifies additional Trauma External Fixation System part numbers that should be considered MR Conditional. One serious injury reported. Synthes (USA) Products LLC
Devices Central Line >34 Weeks Kit. Cardiology department. The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, nutrients, or blood products over a long period of time, usually several weeks or more. A catheter is often inserted in the arm or chest through the skin into a large vein. The catheter is threaded through this vein until it reaches a large vein near the heart. Central Venous Catheter Kit for patients >34 weeks old with the coding below were affected. Lot Numbers: 14DB9277 and 14PB2878 Unit No: DYNDC1987A Expiration Date: 06/2015 Serial No: N/A UPC code: N/A Class II The print plate artwork for this lot was found to state: Central Line <34 Weeks Kit displaying an incorrect sign in front of the 34. The description for this device should have stated Central Line >34 Weeks Kit. The defect may lead to the product to be used on patient population that is <34 weeks rather than intended population of >34 weeks. Medline Industries Inc
Devices ExacTrac 6.0.x Patient Positioning System, Radiation therapy. Intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures. Affected are ExacTrac versions 6.0.0 through 6.0.5 (v. 6.0.0, 6.0.1, 6.0.2, 6.0.3, 6.0.4, 6.0.5). Serial numbers/lot numbers are not applicable for a software version. Software revisions of the ExacTrac software have a specific software version number. Model/catalogue numbers: 70359-01 EXACTRAC 6.0  ...
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Class II ExacTrac 6.0 Patient Positioning System: Display of potentially incorrect Digitally Reconstructed Radiograph (DRR) for x-ray correction and verification. Brainlab AG
Devices Salto Talaris Tibial Guide, Part # MJU333 ,Tray/Kit Code YKAL11, Non sterile. Orthopedic Manual Surgical Instrument Lot #14F005 Class II Tornier has initiated a voluntary recall for the Salto Talaris Tibial Guide (part number MJU333) due to a complaint that occurred during physician training, that the guide cannot be assembled to the Salto Talaris Talar Pin Setting guide. This issue will cause the impossibility the time of putting the Talar pin in the guide. Tornier, Inc
Drugs Bactroban (mupirocin calcium) Nasal Ointment, 2% 1g tube, Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1526-11 Lot #: C704202, Exp 11/2016; Lot #: C706532, Exp 12/2016; Lot #: C713177, Exp 1/2017; Lot #: C716567, Exp 2/2017, Lot #: C720097, C720098, Exp 3/2017 Class II Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process. GlaxoSmithKline, LLC.
Drugs Bactroban Ointment (mupirocin calcium), 2% 22g tube ,Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. NDC 0029-1525-44 Lot #: C698039, Exp 03/2016 Class II Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process. GlaxoSmithKline, LLC.
Drugs Bactroban Cream (mupirocin calcium), 2%, a) 15g tube ( NDC 0029-1527-22), b) 30g tube (NDC 0029-1527-25), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. 15 g: Lot #: C695549, Exp 03/2016; 30 g: Lot #: C707836, Exp 7/2016; C718209, Exp 9/2016. Class II Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process. GlaxoSmithKline, LLC.
Drugs Mupirocin Calcium Cream, 2%, a) 15g tube (NDC 66993-942-15),b) 30g tube (NDC 66993-942-31), Rx only, Manufactured by Glaxo Operations UK Ltd, Harmire Road, Barnard Castle, UK for GlaxoSmithKline PO Box 1217 Zebulon, NC 27597-1217. Lot #: C690076, C693373, Exp 2/2016; Lot #: C701378, C701376, Exp 4/2016; Lot #: C704164, Exp 5/2016; Lot #: C713687, Exp 8/2016; Lot #: C719467,C718203, Exp 9/2016; Lot #: C723641, Exp 10/2016; Lot #: C683884, Exp 12/2016; Lot #: C697653, Exp 3/2016; Lot #: C710477, Exp 7/2016 Class II Penicillin Cross Contamination and Presence of Foreign Substance. Product was contaminated with penicillin and foreign substances during manufacturing process. GlaxoSmithKline, LLC.
Devices LX3 Floor Stand for Endure Luxite Envision Optical System; Endure LuxOR Q-Vue. Product Usage: The LX3 Microscope Floor Stand is an accessory to the LuxOR Opthalmic Microscope and the LuxOR Opthalmic Microscope with Q-VUE 3-D Assistant Visualization and provides a portable suspension system for the microscope that integrates an AC power module and microscope controls (Primary Control Panel and connectivity of foot controllers) All units LX3 Microscope Floor Stands manufactured prior to July 2015 (Serial Numbers 1402548501X to 1502857606X) Class II Alcon is initiating a voluntary recall of all LX3 Microscope Floor Stands after receiving reports concerning loss of functionality due to issues with the cabling between the power, host and illumination modules, potentially causing the system to display a system message, and/or resulting in illumination failure. Alcon Research, Ltd.
Devices Otto Bock Healthcare Products GmbH Genium X3 Model Number: 3B5-2, Manufacturer Otto Bock Healthcare Products GmbH. Intended to be used solely for lower limb prosthetic fittings. Serial Number 201528049, manufactured on 01 July 2015 Class II Otto Bock Healthcare Products GmbH is recalling the new Genium X3 knee joint prosthesis due to issues with the resistance-control of the hydraulics, which may fail under conditions. Otto Bock Healthcare Product
Devices Centricity PACS-IW with Universal Viewer Product Usage: The Centricity PACS-IW with Universal Viewer is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. Used in Radiology. Model Number: Centricity PACS-IW with Universal Viewer Version 5.0 through 5.0 SP7 Codes: 2090255-001 UV 6.0 Web Client Media Kit. 05 Jun 15 to present Class II Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1. GE Healthcare
Devices Centricity Universal Viewer Product Usage: The Centricity Universal Viewer Version 6.0 software is a picture archiving and communications system, a device that provides one or more capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. Its hardware components may include workstations, digitizers, communications devices, computers, video monitors, magnetic, optical disk, or other digital data storage devices, and hardcopy devices. The software components may provide functions for performing operations related to image manipulation, enhancement, compression or quantification. Used in Radiology. Model Number: Centricity Universal Viewer Version 6.0 software Codes: 2090255-001 UV 6.0 Web Client Media Kit. 05 Jun 15 to present Class II Images from the Centricity PACS-IW with Universal Viewer and Centricity Universal Viewer may be missing when a system parameter MapRoute is set to a value greater than 1. GE Healthcare
Drugs Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/10 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-323-30. Lot #: C403575, Expiry: 10/2015 Class III Subpotent Drug: Subpotent atorvastatin. Dr. Reddy's Laboratories, Inc.
Drugs Amlodipine besylate and Atorvastatin calcium Tablets, 2.5 mg/20 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-320-30. Lot #: C403574, Expiry: 10/2015 Class III Subpotent Drug: Subpotent atorvastatin. Dr. Reddy's Laboratories, Inc.
Drugs Amlodipine besylate and Atorvastatin calcium Tablets,2.5 mg/40 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-317-30. Lot #: C402341, Expiry: 08/2015 Class III Subpotent Drug: Subpotent atorvastatin. Dr. Reddy's Laboratories, Inc.
Drugs Amlodipine besylate and Atorvastatin calcium Tablets, 5 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-319-30) and b) 90 Count Bottles (NDC: 43598-319-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. a) Lot #: C403577, Expiry: 10/2015; b) Lot #: C403577, Expiry: 10/2015. Class III Subpotent Drug: Subpotent atorvastatin. Dr. Reddy's Laboratories, Inc.
Drugs Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/20 mg, Packaged in a) 30 Count Bottles (NDC: 43598-318-30) and b) 90 Count Bottles (NDC: 43598-318-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India a) Lot #: C404592, Expiry: 11/2015. b) Lot #: C404592, Expiry: 11/2015 Class III Subpotent Drug: Subpotent atorvastatin. Dr. Reddy's Laboratories, Inc.
Drugs Amlodipine besylate and Atorvastatin calcium Tablets,10 mg/40 mg, Packaged in a) 30 Count Bottles (NDC: 43598-315-30) and b) 90 Count Bottles (NDC: 43598-315-90), Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. a) Lot #: C409650, Expiry: 05/2016; Lot #: C409652,Expiry: 05/2016. b) Lot #: C409652, Expiry: 05/2016 Class III Subpotent Drug: Subpotent atorvastatin. Dr. Reddy's Laboratories, Inc.
Drugs Amlodipine besylate and Atorvastatin calcium Tablets, 10 mg/80 mg, 30 Count Bottles, Rx Only. Manufactured by Dr. Reddy's Laboratories Limited, Bachupally - 500 090 India. NDC: 43598-313-30. Lot #: C404595, Expiry: 11/2015 Class III Subpotent Drug: Subpotent atorvastatin. Dr. Reddy's Laboratories, Inc.
Biologics Cornea 05192015044OS; 05192015044OD; Class II Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Mid-America Transplant Services
Biologics Cornea 05122015023OS; 05122015023OD; Class II Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Mid-America Transplant Services
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