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U.S. Department of Health and Human Services

Enforcement Report - Week of July 29, 2015

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 36GQ40104 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. The American National Red Cross South Carolina Region
Biologics Blood and Blood Products for Reprocessing 36GQ40104 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. The American National Red Cross South Carolina Region
Biologics Red Blood Cells 71P792984 Class II Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed. LifeSouth Community Blood Centers, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 72H231424 Class II Blood product, which did not meet acceptable product specifications, was distributed LifeSouth Community Blood Center, Inc
Biologics Red Blood Cells Leukocytes Reduced W091012132067 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Oklahoma Blood Institute
Biologics Plasma Frozen within 24 hours (FP24) W091012132067 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Oklahoma Blood Institute
Biologics Platelets Pheresis Leukocytes Reduced 4479978, 4479978, 4489040, 4553576, 4553576, 4554484, 4554484, 4554484, 4555031, 4555383, 4555383, 4555999, 4555999, 4603337, 4627161, 4627161, 4628558, 4628558, 4634552, 4634552, 4635120, 4654004, 4654004, 4654317, 4654317, 4654317, 4655318, 4655318, 4655318, 4678181, 4678181, 4678615, 4694669, 4694669, 4694838, 4694838, 4694838, 4695877, 4695877, 4699129, 4731320, 4744482, 4748006, 4748006, 4759498, 4774340, 4774340, 4774340, 4813378,  ...
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Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Oklahoma Blood Institute
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 4489040, 4489040, 4503555, 4516285, 4555031, 4555031, 4603337, 4627161, 4635120, 4678615, 4699129, 4731320, 4731320, 4744482, 4813378, 4813857, 4815480, 4848931, 4848931, 4894320, 4894320, 4905995, 4910523, 4939187, 4940156, 4946060, 4946060, 5218045, 5272166, 5349059, 5408234, 5409531, 5409531, 7148099, 7179387, 7179479, 7179479, 7283030, 7283030, 7619040, 7619040, W091009129218 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Oklahoma Blood Institute
Biologics Red Blood Cells Leukocytes Reduced W128714061801 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Delta Blood Bank
Biologics Recovered Plasma W128714061801 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Delta Blood Bank
Devices Safety PICC Insertion Tray with Chloraprep®OneStep - Model #5026CL-9 - 12 pr case. Packaged for Physician use only. Lot#92414 Exp Date 11/1/15, Lot#100214 Exp Date 11/1/15 Lot#100914 Exp Date 11/1/15 Class II An INCORRECT item number is packed within the OUTSIDE "PIGGYBACKED" PACKAGE. The interior sealed STERILE KIT is correct and NO adverse issues affect that part of the item. The NON-STERILE OUTSIDE "PIGGYBACKED" PACKAGE mistakenly contains ITEM #8881579121 - Syringe prefilled, Saline Flush, 09% Sodium Chloride and is a NONSTERILE PRODUCT that CANNOT BE DROPPED INTO THE STERILE FIELD. Custom Healthcare Systems, Inc.
Devices Various OxyTOTE Portable Oxygen System regulators, Valve Integrated Pressure Regulator, one unit per package. Product Usage: Used to dispense Oxygen at prescribed flow rates to patients for therapeutic purposes and is designed to provide mobility with a self-contained supply of Oxygen. The recall affects all lot numbers (made prior to 10/01/2014) for the following Model Numbers: AAG-403; AAG-800; AAG-802; AAG-803; GTS-303; GTS-4206; GTS-600; GTS-603; JHR-900; JHR-LG-MTS-903; LAW-603; MNR-3000; MNR-600; MNR-800; MNS-602; MNS-603;; MNS-803; MNS-C803; MTR-100; MTR-300; MTR-500; MTR-600; MTR-700; MTR-800; MTS-303; MTS-403; MTS-501; MTS-502; MTS-503; MTS-505; MTS-601; MTS-602; MTS-603; MTS-803; OXC-503;  ...
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Class I The firm has become aware of the possibility of ignition and rupture (explosion) of a compressed gas oxygen cylinder, which can cause serious injury and/or death. Western / Scott Fetzer Company
Biologics Fresh Frozen Plasma W128708180172 Class II Blood product, which tested repeatedly reactive for the antibody to Hepatitis B core antigen (anti-HBc), was distributed. Delta Blood Bank
Devices Polaris 4.75 TI Spinal System, 4.0 x 20 MM, Closed MAS, Closed Head Multiaxial Screw, Non-Sterile, Rx Only, REF 14-583020, Biomet Spine and Bone Healing Technologies. Spinal fixation component. Part Numbers: 14-582020, 14-582022, 14-582025, 14-582030, 14-582035, 14-582040, 14-582120, 14-582122, 14-582125, 14-582127, 14-582130, 14-582135, 14-582140, 14-582220, 14-582222, 14-582225, 14-582230, 14-582235, 14-582240, 14-582245, 14-582250, 14-592320, 14-582325, 14-582330, 14-582335, 14-582340, 14-582345, 14-582350, 14-582530, 14-582535, 14-582540, 14-582545, 14-582550, 14-582565, 14-582570, 14-582575, 14-583020, 14-583025, 14-583030, 14-583035, 14-583040, 14-583120, 14-583125, 14-583130, 14-583135, 14-583140, 14-583220, 14-583225, 14-583230,  ...
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Class II Multiaxial screws may not meet internal requirements related to fatigue strength. Compression testing result and surface treatment are out of specification. Biomet Spine, LLC
Devices PROBEAT WITH DISCRETE SPOT SCANNING SYSTEM Product Usage: Hitachis PROBEAT with DSSS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. No serial number or lot code. Each system is designed for a specific facility therefore no codes are needed for traceability Class II At a PROBEAT III site installed in Japan, the operator of the system found that the radiation was delivered inconsistent with the treatment plan and stopped the irradiation. As a result of the investigation, the company determined that the irradiation control system may be potentially affected when rebooting a part of the control system. Hitachi America, Ltd., Power Systems Division
Drugs Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-421-01. Lot #: DM11774, Expiry: 6/30/2015; Lot #: DM13056, Expiry: 10/31/2015;  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Lisinopril Tablets USP, 2.5 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-927-01) and B) 500 Count Bottles (NDC: 64679-927-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. A) Lot #: DM10573, Expiry: 4/30/2015; Lot #: DM11531, Expiry: 5/31/2015; Lot #: DM11532, Expiry: 5/31/2015; Lot #: DM11676, Expiry: 6/30/2015; Lot #: DM11677, Expiry: 6/30/2015; Lot #: DM12543, Expiry: 8/31/2015; Lot #: DM13333, Expiry: 11/30/2015; Lot #: DN10272, Expiry: 12/31/2015; Lot #: DN10405, Expiry: 12/31/2015; Lot #: DN10446, Expiry:  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Lamotrigine Extended-Release Tablets, 25 mg Tablets, 30 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-271-01. Lot #: DN10114, Expiry: 11/30/2015. Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count Bottles (NDC: 64679-720-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. A) Lot #: DM11488, Expiry: 4/30/2015; Lot #: DM12093,  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Zolpidem Tartrate Tablets, 5 mg Tablets, CIV, Packaged in 100 Tablet Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-714-01. Lot #: DM11802, Expiry: 6/30/2015; Lot #: DM11803, Expiry: 6/30/2015; Lot #: DM12273, Expiry: 7/31/2015; Lot #: DM12274, Expiry: 7/31/2015. Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-08), and C) 3 x 6 Tablet Card Cartons (NDC: 64679-961-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. A) Lot #: LM10712, Expiry: 4/30/2015; Lot #: LM10874, Expiry: 4/30/2015; Lot #: LM11040, Expiry: 5/31/2015; Lot #: LM11169, Expiry: 6/30/2015; Lot #: LM11401, Expiry: 6/30/2015; Lot #: LM12132, Expiry: 11/30/2015; Lot #: LN10039, Expiry: 12/31/2015; Lot #: LN10263, Expiry: 12/31/2015; Lot #: LN10276, Expiry: 12/31/2015; Lot #: LN10417, Expiry:  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Clarithromycin Tablets, USP, 500 mg Tablets, 60 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-949-01. Lot #: LM11172, Expiry: 6/30/2015; Lot #: LN10487, Expiry: 1/31/2016;  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and C) 1000 Count Bottles (NDC: 64679-937-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. A) Lot #: LM10806, Expiry: 5/31/2015; Lot #: LM11099,  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, For Repackaging Only, Packaged in 4500 Count Pouches, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-140-00. Lot #: LN11086, Expiry: 5/31/2015. Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Metoprolol Succinate Extended-Release Tablets, USP, 200 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0737-02) and B) 500 Count Bottles (NDC: 64679-0737-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA . A) Lot #: LN10978, Expiry: 4/30/2015; Lot #: LN11007, Expiry: 4/30/2015; Lot #: LN11013, Expiry: 4/30/2015; Lot #: LN11258, Expiry: 6/30/2015; Lot #: LN11259, Expiry: 6/30/2015; Lot #: LN11277, Expiry: 6/30/2015; Lot #: LN11317, Expiry: 6/30/2015. B) Lot #: LN11255, Expiry: 6/30/2015. Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 500 Count Bottles (NDC: 64679-516-03), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. A) Lot #: LN10896, Expiry: 4/30/2015; Lot #: LN10901, Expiry: 4/30/2015; Lot  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Zonisamide Capsules, 100 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0990-01. Lot #: LM10776, Expiry: 5/31/2015; Lot #: LM10781, Expiry: 5/31/2015;  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Amlodipine Besylate Tablets, 5 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-422-01) and B) 1000 Count Bottles (NDC: 64679-422-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. A) Lot #: DM11421, Expiry: 5/31/2015; Lot #: DM12956,  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Amlodipine Besylate Tablets, 10 mg Tablets, Packaged as A) 90 Count Bottles (NDC: 64679-423-01) and B) 1000 Count Bottles (NDC: 64679-423-02, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. A) Lot #: DM12975, Expiry: 10/31/2015; Lot #: DM12976, Expiry: 10/31/2015; Lot  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Lisinopril Tablets USP, 5 mg Tablets,Packaged in A) 100 Count Bottles (NDC: 64679-928-01), B) 500 Count Bottles (NDC: 64679-928-05), and C) 1000 Count Bottles (NDC: 64679-928-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. A) Lot #: DM10991, Expiry: 4/30/2015; Lot #: DM11226,  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Lisinopril Tablets USP, 10 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-929-01), B) 500 Count Bottles (NDC: 64679-929-05), and C) 1000 Count Bottles (NDC: 64679-929-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. A) Lot #: DM11197, Expiry: 4/30/2015; Lot #: DM11202,  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Lisinopril Tablets USP, 20 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-941-01), B) 500 Count Bottles (NDC: 64679-941-05), and C) 1000 Count Bottles (NDC: 64679-941-06), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. A) Lot #: DM11334, Expiry: 4/30/2015; Lot #: DM11551,  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Lisinopril Tablets USP, 30 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-953-01) and B) 500 Count Bottles (NDC: 64679-953-05), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. A) Lot #: DM11003, Expiry: 4/30/2015; Lot #: DM11094, Expiry: 4/30/2015; Lot #: DM11689, Expiry: 6/30/2015; Lot #: DM11873, Expiry: 6/30/2015; Lot #: DM11874, Expiry: 6/30/2015; Lot #: DM12402, Expiry: 8/31/2015; Lot #: DM12412, Expiry: 8/31/2015; Lot #: DM13440, Expiry: 11/30/2015; Lot #: DN10689, Expiry: 1/31/2016; Lot #: DN10693, Expiry:  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Lisinopril Tablets USP, 40 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-942-01), B) 500 Count Bottles (NDC: 64679-942-05), and C) 1000 Count Bottles (NDC: 64679-942-02), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. A) Lot #: DM11040, Expiry: 4/30/2015; Lot #: DM11463, Expiry: 5/31/2015; Lot #: DM11497, Expiry: 5/31/2015; Lot #: DM11498, Expiry: 5/31/2015; Lot #: DM12126, Expiry: 7/31/2015; Lot #: DM12132, Expiry: 7/31/2015; Lot #: DM12172, Expiry: 7/31/2015; Lot #: DM12176, Expiry: 7/31/2015; Lot #: DN10325, Expiry: 12/31/2015; Lot #: DN10892, Expiry:  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Zolpidem Tartrate Tablets, 10 mg Tablets, CIV, Packaged in A) 100 Count Bottles (NDC: 64679-715-01) and B) 500 Count Bottles (NDC: 64679-715-04), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. A) Lot #: DM11608, Expiry: 5/31/2015; Lot #: DM11609, Expiry: 5/31/2015; Lot #: DN10190, Expiry: 12/31/2015. B) Lot #: DM11186, Expiry: 4/30/2015; Lot #: DM11607, Expiry: 5/31/2015; Lot #: DM13298, Expiry: 10/31/2015; Lot #: DN10188, Expiry: 12/31/2015; Lot #: DN10189, Expiry: 12/31/2015. Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64679-964-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. A) Lot #: LM10739, Expiry: 4/30/2015; Lot #: LM10991,  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Azithromycin Tablets, USP, 600 mg Tablets, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-962-01. Lot #: LN10991, Expiry: 4/30/2015; Lot #: LN11381, Expiry: 7/31/2015. Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), and C) 1000 Count Bottles (NDC: 64679-936-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. A) Lot #: LM10708, Expiry: 4/30/2015; Lot #: LM10859,  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Famotodine Tablets, USP, 20 mg Tablets, For Repacking Only, Packaged in 6500 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0374-09. Lot #: LN11320, Expiry: 7/31/2015; Lot #: LN11341, Expiry: 8/31/2015. Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Famotodine Tablets, USP, 10 mg Tablets, For Repacking Only, Packaged in 50,000 Count Drums, Over the Counter. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0972-00. Lot #: LM10826, Expiry: 5/31/2015; Lot #: LM10999, Expiry: 5/31/2015;  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Lansoprazole Delayed-Release Capsules, USP, 15 mg Capsules, Packaged in 30 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0669-01. Lot #: LN11008, Expiry: 4/30/2015. Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Lansoprazole Delayed-Release Capsules, USP, 30 mg Capsules, Packaged in A) 30 Count Bottles (NDC: 64679-0670-01), B) 90 Count Bottles (NDC: 64679-0670-07), and C) 1000 Count Bottles (NDC: 64679-0670-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. A) Lot #: LN10933, Expiry: 4/30/2015; Lot #: LN10935, Expiry: 4/30/2015; Lot #: LN11063, Expiry: 4/30/2015. B) Lot #: LN10987, Expiry: 4/30/2015; Lot #: LN11415, Expiry: 6/30/2015. C) Lot #: LN10986, Expiry: 4/30/2015; Lot #: LN11414, Expiry: 6/30/2015. Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0736-02), B) 500 Count Bottles (NDC: 64679-0736-03), and C) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0736-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC, 20 Waterview Blvd. Parsippany, NJ 07054 USA . A) Lot #: LN11010, Expiry: 4/30/2015; Lot #: LN11011,  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Metoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bottles (NDC: 64679-0735-03), C) 4000 Count Pouches, For Repacking Only (NDC: 64679-0735-08), and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0735-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. A) Lot #: LN10967, Expiry: 4/30/2015; Lot #: LN10968, Expiry: 4/30/2015; Lot #: LN10969, Expiry: 4/30/2015; Lot #: LN11076, Expiry: 4/30/2015; Lot #: LN11077, Expiry: 4/30/2015; Lot #: LN11078, Expiry: 4/30/2015; Lot #: LN11126, Expiry: 5/31/2015; Lot #: LN11127, Expiry: 5/31/2015; Lot #: LN11326, Expiry:  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Metoprolol Succinate Extended-Release Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0734-02), B) 500 Count Bottles (NDC: 64679-0734-03), C) 8000 Count Pouches, For Repacking Only (NDC: 64679-734-08) and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0734-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. A) Lot #: LN11050, Expiry: 4/30/2015; Lot #: LN11053,  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Zonisamide Capsules, 50 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0946-01. Lot #: LM10769, Expiry: 4/30/2015; Lot #: LM10770, Expiry: 4/30/2015;  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Zonisamide Capsules, 25 mg Capsules, Packaged in 100 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0945-01. Lot #: LM10763, Expiry: 4/30/2015; Lot #: LM10764, Expiry: 4/30/2015;  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Captopril Tablets, USP, 25 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0903-01) and B) 1000 Count Bottles (NDC: 64679-0903-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. A) Lot #: LM10843, Expiry: 5/31/2015; Lot #: LM11331, Expiry: 7/31/2015; Lot #: LM11332, Expiry: 7/31/2015; Lot #: LM11376, Expiry: 7/31/2015; Lot #: LM11583, Expiry: 8/31/2015; Lot #: LM11987, Expiry: 11/30/2015; Lot #: LN10065, Expiry: 12/31/2015; Lot #: LN10066, Expiry: 12/31/2015; Lot #: LN10334, Expiry:  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Captopril Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0904-01) and B) 1000 Count Bottles (NDC: 64679-0904-02), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. A) Lot #: LM11093, Expiry: 6/30/2015; Lot #: LM11335, Expiry: 7/31/2015; Lot #: LM11336, Expiry: 7/31/2015; Lot #: LM11461, Expiry: 8/31/2015; Lot #: LM11462, Expiry: 8/31/2015; Lot #: LM11579, Expiry: 8/31/2015; Lot #: LM11778, Expiry: 9/30/2015; Lot #: LM11995, Expiry: 11/30/2015; Lot #: LN10029, Expiry: 11/30/2015; Lot #: LN10071, Expiry:  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Drugs Captopril Tablets, USP, 100 mg Tablets, Packaged in 100 Count Bottles, Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-0905-01. Lot #: LM11354, Expiry: 7/31/2015; Lot #: LM11355, Expiry: 7/31/2015;  ...
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Class II CGMP Deviations: Firm did not adequately investigate customer complaints. Wockhardt Usa Inc.
Devices Covidien Devon Light Gloves, Sterile-Single Units A disposable, sterile, single-use cover for compatible surgical light handles. Catalog/Number/Description 31140208 3611 LIGHT GLOVE 31140216 3613 LIGHT GLOVE 31140257 3612 LIGHT GLOVE Lot number begins 508xxxx or lower Class II Devon Light Gloves contain splits or holes compromising the sterility Covidien LLC
Devices Delivery/C-Section, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 56479 7335-SMC C-Section Kit 31404851 7382-OTO2 Delivery Kit 52000076E 7339-ES C-SECTION DELUXE PACK 52000082E 7335-HUV DELIVERY KIT Lot number begins 508xxxx or lower Class II Devon Light Gloves contain splits or holes compromising the sterility Covidien LLC
Devices Mini-Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description 31141479 K-1842-S OR Mini Kit 31141487 K-1560-S3 OR Mini Kit 31141495 K-1530-S3 OR Mini Kit 31141537 K-1940-S OR Mini Kit 31141552 K-1920-S OR Mini Kit 31141560 K-1200-S3 OR Mini Kit 31141578 K-1840-S OR Mini Kit 31141586 K-1660-S OR Mini Kit 31141602 K-1630-S OR Mini Kit 31141610 K-1615-S OR Mini Kit 31141628 K-1614-S OR Mini Kit 31141651 K-1560-S OR Mini Kit 31141669 K-1530-S OR Mini Kit 31141677 K-1200-S OR Mini Kit 31141784 K-1960-S OR Mini Kit 31141859 K-1615-S3 OR Mini Kit 31141875 K-1940-S3 OR Mini Kit 31145025 7496-8 MINI-PLUS KIT 31145397 7497-8 MINI-PLUS KIT 31145413 7497-88 Mini-Plus Kit 31150470 7496-PUP MINI PLUS KIT 50000148 K-1920-COE MINI-KIT 50047403 7496-HCS MINI-PLUS KIT 50047405 7496-HES MINI-PLUS KIT 573375A MINI-PLUS KIT Lot number begins 508xxxx or lower Class II Devon Light Gloves contain splits or holes compromising the sterility Covidien LLC
Devices Minor Surgical Kits, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573208 7519-DHCG MINOR KIT 573210 7581-CSD Minor KIT 573741 7667-HMI Minor Kit 31144507 7519 Minor Surgical Kit 573830D MINOR KIT Lot number begins 508xxxx or lower Class II Devon Light Gloves contain splits or holes compromising the sterility Covidien LLC
Devices Surgical Set Up kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31144895 7614-T4 Single Basin Set Up Kit 31144960 7693-T4 Single Basin Set Up Kit 31144978 7766 Double Basin Set Up Kit 31145215 7896 Double Basin Set Up Kit 31145231 7897 Double Basin Set Up Kit 31145249 7897-T8 Double Basin Set Up Kit 31145298 7896-T8 Double Basin Set Up Kit 31145496 7696-T4 Single Basin Set Up Kit 31145520 7614 Single Basin Set Up Kit 31145546 7693 Single Basin Set Up Kit 31145629 7696 Single Basin Set Up Kit 31153938 7756-KST Surgical Set Up Kit 31154266 7656-KST Surgical Set Up Kit 31321097 7697 Surgical Set Up Kit 31324299 7830-HOH Surgical Set Up Kit 31451092 7600-DNV Surgical Set Up Kit 31453098 7682-MHP Surgical Set Up Kit Lot number begins 508xxxx or lower Class II Devon Light Gloves contain splits or holes compromising the sterility Covidien LLC
Devices ASC (Breast) Kit, Sterile-Kits containing the Devon Light Glove Catalog Numbers/Decription: 573328 7437-NRF SURGICAL ASC KIT 50000511 7516-UNI Universal ASC Kit 50000512 7557-UNI Universal ASC Kit 50000515 7667-BRT Breast ASC Kit Lot number begins 508xxxx or lower Class II Devon Light Gloves contain splits or holes compromising the sterility Covidien LLC
Devices Surgical Kit Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 573326 7497-HLS Surgical Kit 573328 7437-NRF SURGICAL ASC KIT 573343 7499-88 SURGICAL KIT with Light Gloves 573346 7499-TLG Surgical Kit with Edge 573359 7499-HLW Surgical KIT 573368 7494-CAB2 SURGICAL KIT 573776 7520-BHP SURGICAL KIT 573777 7527-BHB SURGICAL KITS 573798 7496-8KB Surgical KIT 31144507 7519 Minor Surgical Kit 31175089 7497-8T6 Surgical Kit 31321097 7697 Surgical Set Up Kit 31451480 7493-SFW SURGICAL KIT 31460432 7596-SHH Surgical KIT 50000947 7413-CAD Surgical KIT 50001029 7417-PCP Surgical KIT 50001052 7427-CFS Surgical KIT Lot number begins 508xxxx or lower Class II Devon Light Gloves contain splits or holes compromising the sterility Covidien LLC
Devices Double Basin Kit ,Sterile-Kits containing the Devon Light Glove Catalog Numbers/Description: 31145504 7708 Double Basin Kit 50007898 7898-T8 Double Basin Kit 50007899 7899-T8 Double Basin Kit Lot number begins 508xxxx or lower Class II Devon Light Gloves contain splits or holes compromising the sterility Covidien LLC
Devices Major Kit, Sterile-.Kits containing the Devon Light Glove Catalog Number:Description 573831B MAJOR KIT Lot number begins 508xxxx or lower Class II Devon Light Gloves contain splits or holes compromising the sterility Covidien LLC
Devices Single Basin Kits, Sterile-.Kits containing the Devon Light Glove Catalog Number/Description: 573509 7696-GSL-VL SINGLE BASIN KIT 573558 7665-CPB SINGLE BASIN KIT 573561 7696-KSC SINGLE BASIN KIT 31145645 7608 Single Basin KIT 31153060 7697-T4 Single Basin Kit 50000568 7605-SEC Single Basin Kit 50000599 7694-ADA Single Basin Kit 50007698 7698-T4 Single Basin Kit 50007699 7699-T4 Single Basin Kit Lot number begins 508xxxx or lower Class II Devon Light Gloves contain splits or holes compromising the sterility Covidien LLC
Devices Augmentation Kit , Sterile-.Kits containing the Devon Light Glove Catalog Number/Description 573732 7620-CWA Augmentation Kit Lot number begins 508xxxx or lower Class II Devon Light Gloves contain splits or holes compromising the sterility Covidien LLC
Devices NS-3600-B LITE GLOVE 1000/CASE -Bulk, Non-sterile Catalog Number: 571711 Lot number begins 508xxxx or lower Class II Devon Light Gloves contain splits or holes compromising the sterility Covidien LLC
Devices Non Sterile Subassembly: Catalog Number/Description: SA1008 NONSTERILE SUBASSEMBLY SA1578 NO-STERILE SUBASSEMBLY SA2000 NON STERILE SUBASSEMBLY SA2001 NON STERILE SUBASSEMBLY SA2002 NON STERILE SUBASSEMBLY SA2004 NON STERILE SUBASSEMBLY SA2005 NON STERILE SUBASSEMBLY SA2006 NON STERILE SUBASSEMBLY SA2007 NON STERILE SUBASSEMBLY SA2008 SA-7457-R NS SUBASSEMBLY SA2032B NSSA SA2038A NSSA SA2042 SA2042 SUBASSEMBLY NS SA2049 SA2049 NON STERILE SUBASSEMBLY SA2058B NSSA SA2074 SA2074 NON STERILE SUBASSEMBLY SA2075 SA2075 NON STERILE SUBASSEMBLY SA2109 SA2109 NON STERILE SUBASSY SA2119 SA2119 NON STERILE SUBASSY SA2120 SA2120 NON STERILE SUBASSY SA2121 NON STERILE SUBASSY SA2122 SA2122 NON STERILE SUBASSY SA2164A NSSA SA2172A NSSA SA2172B NSSA SA2173C NSSA SA2174B NSSA SA2185 SRM800 NSSA SA2198D NSSA SA2199 SA2199 NON STERILE SUBASSY SA2219 NSSA SA3011 SA3011 NON STERILE SUBASSY SA3013 SA3013 NON STERILE SUBASSY SA3018 SA3018 NON STERILE SUBASSY SA3040 SA3040 NON STERILE SUBASSY SA3045 NSSA SA3060 SA3060 NON STERILE SUBASSY SA3062A NSSA SUBASSEMBLY SA3068 SA3068 NON STERILE SUBASSY SA3069 SA3069 NON STERILE SUBASSY SA3071 SA3071 NON STERILE SUBASSY SA3076 NSSA SA3076A NSSA SA3077 NSSA BUTTON SA3078 NSSA ROCKER SA3080 NSSA SA4003 NON STERILE SUBASSEMBLY SA4003A NON STERILE SUBASSEMBLY SA4013 NSSA SA4014 NSSA SA4015 NSSA SA5006 NSSA SA5015 NSSA SA5017 NON STERILE SUBASSEMBLY SA2140 SA2140 NON STERILE SUBASSY Lot number begins 508xxxx or lower Class II Devon Light Gloves contain splits or holes compromising the sterility Covidien LLC
Devices Hysto Pack, Non-sterile Part Number Description SA2059B MAJOR BASIN SA2220 HYSTO PACK SA2220A HYSTO PACK Lot number begins 508xxxx or lower Class II Devon Light Gloves contain splits or holes compromising the sterility Covidien LLC
Devices Head Holder shipped with Ingenuity Core Computed Tomography X-ray Systems. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Head Holder M/N 4535 671 11331. Ingenuity Core - M/N 728321, Serial #s: 7725, 10614, 10663, 50171, 95735, 300072, 310001, 310006, 310008, 310009, 310010, 310012, 310013, 310014, 310015, 310017, 310018, 310020, 310021, 310022, 310024, 310025, 310026, 310028, 310029, 310030, 310031, 310032, 310033, 310034, 310035, 310037, 310038, 310039, 310040, 310041, 310042,  ...
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Class II A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core, which was shipped with this system. Philips Medical Systems (Cleveland) Inc
Devices Head Holder shipped with Ingenuity Core 128 Computed Tomography X-ray Systems. Intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. Head Holder M/N 4535 671 11331. Ingenuity Core 128 - M/N 728323, Serial #s: 300068, 320003, 320004, 320005, 320006, 320007, 320008, 320009, 320010, 320011, 320013, 320014, 320015, 320017, 320018, 320019, 320020, 320021, 320022, 320023, 320024, 320025, 320026, 320027, 320028, 320029, 320030, 320031, 320032, 320033, 320034, 320035, 320036, 320037, 320038, 320040,  ...
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Class II A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity Core 128, which was shipped with this system. Philips Medical Systems (Cleveland) Inc
Devices Head Holder shipped with Ingenuity CT Computed Tomography X-ray Systems Head Holder M/N 4535 671 11331. Ingenuity CT M/N 728326, Serial #s: 6617, 10607, 10689, 32000, 300043, 300064, 300068, 300071, 300072, 300073, 300074, 300075, 300076, 300077, 300078, 300079, 300080, 300081, 300082, 300084, 300085, 300086, 300087, 300088, 300089, 300091, 300092, 300093, 300094, 300095, 300096, 300097, 300098, 300099, 300100, 300101, 300102, 300103,  ...
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Class II A head holder released for use with other CT systems but not yet qualified for use on the Ingenuity CT, which was shipped with this system. Philips Medical Systems (Cleveland) Inc
Devices American Catheter / Cholangiogram Catheter 9100 Series. Intended for injection of contrast dye into the cystic duct prior to a laparoscopic removal of the gall bladder. Product Number is 9100, Lot # 14101601. Class II Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution. American Catheter Corp
Biologics Red Blood Cells W012914007146 Class II Blood product, collected from a donor with a low hemoglobin, was distributed. Womack Army Medical Center Department of Pathology
Biologics Blood and Blood Products for Reprocessing W204115121761 Class III Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. American Red Cross Blood Services
Devices ADVIA Centaur Tnl-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage: For in vitro diagnostic use in the quantitative determination of cardiac troponin I (cTnl) in serum, heparinized plasma, or EDTA plasma using the ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT/ADVIA Centaur CP systems. Cardiac troponin I determinations aid in the diagnosis of acute myocardial infarction and in the risk stratification of patients with non-ST segment elevation acute coronary syndromes with respect to relative risk of mortality, myocardial infarction (MI) or increased probability of ischemic events requiring urgent revascularization procedures. ***This field action applies to all in-date lots of reagents (Kit lots ending in 088, 089, 090, 091, 093 and 094) and all future lots until the issue is resolved and a follow-up communication is issued by Siemens.**** SMN 10317708 - 100 tests 43796099 May 25, 2015 43818088 May 25, 2015 44793088 May 25,  ...
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Class II System-to-system bias between the Tnl-Ultra assay on the ADVIA Centaur CP and ADVIA Centaur/ADVIA Centaur XP/ADVIA Centaur XPT systems. Siemens Healthcare Diagnostics, Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W205314006829; W205314000743X (2 units) Class II Blood products, which were stored at unacceptable temperatures, were distributed. Department of the Air Force, 779th Medical Group
Biologics Red Blood Cells W0120141030986; W0120141030978; W012014103095C; W012014103094E; Class II Blood products, which were stored at unacceptable temperatures, were distributed. Department of the Air Force, 779th Medical Group
Devices Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wizard²" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. Serial Numbers: DG01130080 DG01130128 DG02130139 DG02130158 DG02130178 DG03130208 DG03130232 DG03130261 DG04129163 DG04130302 DG04130313 DG04130333 DG05130345 DG06129271 DG07129377 DG07129415 DG07129440 DG08129500 DG10095598 DG10129695 DG10129757 DG10129798 DG11129811 DG11129855 DG11129869 DG12118732 DG12120022 SGWZ01140092 SGWZ01150226 SGWZ05150239 SGWZ06150241 SGWZ08150247 SGWZ09140113 SGWZ09140114 SGWZ10140116 SGWZ13130003 SGWZ17130006 SGWZ17140135 SGWZ18140139 SGWZ18140140 SGWZ20140147 SGWZ23130016 SGWZ23130017 SGWZ27140164 SGWZ29130025 SGWZ32140179 SGWZ32140180 SGWZ33130034 SGWZ35140190 SGWZ36140192 SGWZ36140193 SGWZ37130043 SGWZ42140204 SGWZ42140207 SGWZ44130058 SGWZ45130063 SGWZ45130065 SGWZ46130068 SGWZ47130075 SGWZ48130077 SGWZ48130078 SGWZ50130087 SGWZ50130088 Class II Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Perkinelmer
Devices WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wizard²" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. Serial Numbers: DG01130042 DG01130083 DG01130122 DG02130179 DG03130196 DG03130242 DG04130300 DG04130318 DG05129208 DG05129239 DG05129251 DG05130343 DG06129284 DG06129320 DG07129407 DG07129433 DG08118247 DG08129522 DG08129575 DG09129612 DG09129619 DG09129643 DG10129707 DG10129728 DG10129768 DG11129836 DG11129838 DG12120004 DG12120038 SGWZ03150235 SGWZ04140103 SGWZ07140107 SGWZ07140108 SGWZ14140125 SGWZ16140131 SGWZ16140134 SGWZ20140150 SGWZ21140152 SGWZ27130022 SGWZ28140168 SGWZ29130026 SGWZ32130030 SGWZ33140183 SGWZ35140188 SGWZ36130039 SGWZ37130044 SGWZ39130048 SGWZ42130051 SGWZ43130053 SGWZ43130056 SGWZ44130057 SGWZ45130062 SGWZ47130076 Class II Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Perkinelmer
Devices WIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470-0050 The Wizard²" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. Serial Numbers: DG03130211 DG04130287 DG05130344 DG06129306 DG08129516 DG08129541 DG08129542 DG08129582 DG08129593 DG10129714 DG10129720 DG11095720 DG12118684 DG12129915 DG12129916 DG12129917 DG12129918 SG24700050 SGWZ01150227 SGWZ02150229 SGWZ02150230 SGWZ03150232 SGWZ04140102 SGWZ06140105 SGWZ10150251 SGWZ11140117 SGWZ11140119 SGWZ12130002 SGWZ16140130 SGWZ16140133 SGWZ17140136 SGWZ19140145 SGWZ20130007 SGWZ21140154 SGWZ24140160 SGWZ25140161 SGWZ29140169 SGWZ30140174 SGWZ31140176 SGWZ34130036 SGWZ39130046 SGWZ42130052 SGWZ42140205 SGWZ42140206 SGWZ43130054 SGWZ43140208 SGWZ43140209 SGWZ46140215 SGWZ46140216 SGWZ47140217 SGWZ47140218 SGWZ48130079 SGWZ50130085 Class II Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Perkinelmer
Devices Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0100 The Wizard²" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. Serial Numbers: Model: 2470-0100 (51 units) DG01130134 DG02130152 DG03130216 DG03130255 DG04130263 DG04130279 DG04130289 DG04130328 DG05129261 DG06106456 DG06129310 DG08129556 DG10129701 DG10129780 DG11129850 DG11129872 DG12118702 DG12120031 DG12129891 SGWZ02140093 SGWZ02140094 SGWZ03140098 SGWZ03140099 SGWZ03140100 SGWZ05140104 SGWZ06150243 SGWZ07150244 SGWZ09150248 SGWZ10150252 SGWZ11150255 SGWZ12130001 SGWZ16140132 SGWZ17140137 SGWZ19140144 SGWZ20140148 SGWZ21130009 SGWZ21140151 SGWZ24130019 SGWZ27130021 SGWZ27140166 SGWZ29140171 SGWZ31140175 SGWZ34130035 SGWZ36130038 SGWZ37140196 SGWZ45130061 SGWZ45130067 SGWZ48140219 SGWZ49140222 SGWZ50130086 SGWZ52130091 Model: 3470-0100 (3 units) DG11129817, SGWZ21130010,SGWZ27140163 Class II Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Perkinelmer
Devices Perkin Elmer WIZARD2 5-detector, 1 000 samples Product Code: 2470-0150, 3470-0150 The Wizard²" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. Serial Numbers: Model: 2470-0150 (1 unit): SGWZ36130042 Model: 3470-0150 (1 unit): SGWZ19140141 Class II Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Perkinelmer
Devices Perkin Elmer WIZARD2 10-detector, 1000 samples Product Code: 2470-0200, 3470-0200 The Wizard²" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. Serial Numbers: Model: 2470-0200 (13 units DG05129229 DG07118106 DG10129753 SGWZ01150228 SGWZ03140101 SGWZ03150234 SGWZ11140118 SGWZ21130011 SGWZ21130012 SGWZ28130023 SGWZ34140184 SGWZ34140185 SGWZ36130040 Model: 3470-0200 (5 units) DG08129543, DG11129863, SGWZ06150240,SGWZ30130027, SGWZ31130028 Class II Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Perkinelmer
Devices Perkin Elmer WIZARD2 1-detector,3", 1000 samples Product Code: 2480-0010 The Wizard²" gamma counter is intended to detect and count gamma radiation emitted by clinical samples. Serial Numbers: DG01130076 DG01130081 DG01130107 DG01130113 DG02130148 DG02130157 DG02130171 DG02130172 DG02130174 DG02130176 DG03129032 DG03130218 DG03130220 DG03130223 DG03130225 DG03130227 DG03130240 DG03130247 DG04106271 DG04129101 DG04129141 DG04129168 DG05129187 DG05129210 DG05129256 DG05129258 DG06117938 DG06129274 DG06129282 DG06129289 DG06129333 DG06129336 DG06129341 DG06129343 DG06129345 DG06129346 DG06129354 DG07129436 DG07129444 DG07129445 DG07129446 DG07129448 DG07129449 DG08118168 DG08118169 DG08129491 DG08129502 DG08129505 DG08129506 DG08129544 DG08129545 DG08129595 DG09129607 DG09129622 DG09129623 DG09129644 DG10129700 DG10129708 DG10129717 DG10129726 DG10129759 DG10129763 DG10129777 DG10129784 DG11095721 DG11129816 DG11129823 DG11129839 DG11129854 DG12120039 DG12129887 DG12129893 DG12129902 DG12129903 DG12129904 DG12129905 DG12129931 DG12129932 SGWZ02140095 SGWZ02140096 SGWZ02140097 SGWZ02150231 SGWZ03150233 SGWZ04150236 SGWZ04150237 SGWZ07140106 SGWZ07150245 SGWZ08140109 SGWZ08140110 SGWZ08140111 SGWZ08150246 SGWZ09140112 SGWZ10140115 SGWZ10150250 SGWZ11150253 SGWZ12140120 SGWZ12140121 SGWZ12140122 SGWZ13140123 SGWZ13140124 SGWZ14130004 SGWZ15140127 SGWZ15140129 SGWZ17130005 SGWZ18140138 SGWZ19140142 SGWZ19140143 SGWZ20130008 SGWZ20140146 SGWZ20140149 SGWZ21140153 SGWZ22130013 SGWZ22130014 SGWZ22140155 SGWZ22140156 SGWZ23130015 SGWZ23140157 SGWZ24140158 SGWZ25130020 SGWZ27140162 SGWZ27140165 SGWZ28140167 SGWZ29140170 SGWZ30140172 SGWZ30140173 SGWZ31130029 SGWZ31140177 SGWZ31140178 SGWZ32130031 SGWZ32140181 SGWZ32140182 SGWZ33130032 SGWZ33130033 SGWZ34140186 SGWZ35130037 SGWZ35140187 SGWZ35140189 SGWZ36130041 SGWZ36140191 SGWZ36140194 SGWZ37130045 SGWZ37140195 SGWZ39130047 SGWZ39140197 SGWZ39140198 SGWZ40140199 SGWZ40140200 SGWZ41130049 SGWZ42130050 SGWZ42140201 SGWZ42140202 SGWZ42140203 SGWZ43130055 SGWZ44130059 SGWZ44130060 SGWZ44140210 SGWZ44140211 SGWZ45130064 SGWZ45130066 SGWZ45140212 SGWZ45140213 SGWZ45140214 SGWZ46130069 SGWZ46130070 SGWZ46130071 SGWZ46130072 SGWZ47130073 SGWZ47130074 SGWZ48140220 SGWZ48140221 SGWZ49130081 SGWZ49130082 SGWZ49130083 SGWZ49140223 SGWZ50130084 SGWZ51130089 SGWZ51130090 SGWZ51140224 SGWZ52140225 Class II Error in WIZARD2 Barcode ID Label #023 Content may produce erroneous results Perkinelmer
Biologics Blood and Blood Products for Reprocessing W137515201010 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. Lane Memorial Blood Bank
Biologics Blood and Blood Products for Reprocessing W0411140812078 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Blood Systems, Inc. dba United Blood Services Texas
Biologics Platelets Pheresis Leukocytes Reduced W203215849532; W2032158495321; W203215849538; W203215849545; W2032158495451; W2032158495452; W203215849549; W203215849555; W2032158495551; W2032158495552; W203215849562; W2032158495621; W2032158495622; W203215849568; W2032158495681; W203215849572; W2032158495721 Class II Blood products, which did not meet the acceptable product specifications, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced W201115346859 Class III Blood product, which was missing a portion of the required amount of additive solution, was distributed. American Red Cross Blood Services
Devices Bausch & Lomb SofPort Advanced Optics Aspheric Lens Produce Code: LI61AO and LI61SE. LOT #'s 4455501 4455723 4456117 4456118 4456123 4456207 4456213 4456214 4456306 4456316 4456318 4456319 4456403 4456406 4456412 4456413 4456414 4456415 4456416 4456703 4456704 4456707 4456710 4456711 4456712 4456713 4456714 4456715 4456716 4456717 4456718 4456719 4456720 4456721 4456722 4456723 4456724 4456725 4456726 4456727 4456801 4456803 4456804  ...
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Class II Haptics breaking during lens loading and insertion. Bausch & Lomb Surgical, Inc.
Devices Bausch & Lomb SoFlex SE Foldable intraocular Lens Product Usage: The SofPort/SoFlex IOLs are intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients. Produce Code: LI61AO and LI61SE. LOT #'s 4455501, 4455723, 4456117, 4456118, 4456123, 4456207, 4456213, 4456214, 4456306, 4456316, 4456318, 4456319, 4456403, 4456406, 4456412, 4456413, 4456414, 4456415, 4456416, 4456703, 4456704, 4456707, 4456710, 4456711, 4456712, 4456713, 4456714, 4456715, 4456716, 4456717, 4456718, 4456719, 4456720, 4456721, 4456722, 4456723, 4456724, 4456725, 4456726, 4456727, 4456801, 4456803, 4456804,  ...
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Class II Haptics breaking during lens loading and insertion. Bausch & Lomb Surgical, Inc.
Devices ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components. Product Codes: 254500503, 254500504, 254500505, 254500506, 254500507, and 254500508. GTIN: 10603295132431, 10603295132448, 10603295132455, 10603295132462, 10603295132479, and 10603295132486. Class II DePuy Orthopaedics, Inc. is voluntarily issuing a device correction for all lots of the ATTUNE® INTUITION" Tibial Articulation Surface Instruments used in trialing with the ATTUNE Knee System. The device correction is being issued due to the potential for the Balseal, which is a small wire spring coil located on the post feature of the Articulation Surface Instruments to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation. DePuy Orthopaedics, Inc.
Devices ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components. Product Codes: 254500523, 254500524, 254500525, 254500526, 254500527, and 254500528. GTIN: 10603295132639, 10603295132646, 10603295132653, 10603295132660, 10603295132677, and 10603295132684. Class II DePuy Orthopaedics, Inc. is voluntarily issuing a device correction for all lots of the ATTUNE® INTUITION" Tibial Articulation Surface Instruments used in trialing with the ATTUNE Knee System. The device correction is being issued due to the potential for the Balseal, which is a small wire spring coil located on the post feature of the Articulation Surface Instruments to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation. DePuy Orthopaedics, Inc.
Devices ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components. Product Codes: 254500543, 254500544, 254500545, 254500546, 254500547, and 254500548. GTIN: 10603295132837, 10603295132844, 10603295132851, 10603295132868, 10603295132875, and 10603295132882. Class II DePuy Orthopaedics, Inc. is voluntarily issuing a device correction for all lots of the ATTUNE® INTUITION" Tibial Articulation Surface Instruments used in trialing with the ATTUNE Knee System. The device correction is being issued due to the potential for the Balseal, which is a small wire spring coil located on the post feature of the Articulation Surface Instruments to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation. DePuy Orthopaedics, Inc.
Devices ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components. Product Codes:254500981, 254500982, 254501989, and 254501990. GTIN: 10603295135586, 10603295135593, 10603295423492, and 10603295423959. Class II DePuy Orthopaedics, Inc. is voluntarily issuing a device correction for all lots of the ATTUNE® INTUITION" Tibial Articulation Surface Instruments used in trialing with the ATTUNE Knee System. The device correction is being issued due to the potential for the Balseal, which is a small wire spring coil located on the post feature of the Articulation Surface Instruments to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation. DePuy Orthopaedics, Inc.
Devices ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components. Product Codes: 254500563, 254500564, 254500565, 254500566, 254500567, and 254500568. GTIN: 10603295133032, 10603295133049, 10603295133056, 10603295133063, 10603295133070, and 10603295133087. Class II DePuy Orthopaedics, Inc. is voluntarily issuing a device correction for all lots of the ATTUNE® INTUITION" Tibial Articulation Surface Instruments used in trialing with the ATTUNE Knee System. The device correction is being issued due to the potential for the Balseal, which is a small wire spring coil located on the post feature of the Articulation Surface Instruments to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation. DePuy Orthopaedics, Inc.
Devices ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components. Product Codes:254500971, 254500972, 254500973, 254500974, 254500975, 254500976, 254500977, 254500978, 254500979, and 254500980. GTIN: 10603295135487, 10603295135494, 10603295135500, 10603295135517, 10603295135524, 10603295135531, 10603295135548, 10603295135555, 10603295135562, and 10603295135579. Class II DePuy Orthopaedics, Inc. is voluntarily issuing a device correction for all lots of the ATTUNE® INTUITION" Tibial Articulation Surface Instruments used in trialing with the ATTUNE Knee System. The device correction is being issued due to the potential for the Balseal, which is a small wire spring coil located on the post feature of the Articulation Surface Instruments to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation. DePuy Orthopaedics, Inc.
Devices ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components. Product Codes:254500991, 254500992, 254500993, 254500994, 254500995, 254500996, 254500997, 254500998, and 254500999. GTIN: 10603295135685, 10603295135692, 10603295135708, 10603295135715, 10603295135722, 10603295135739, 10603295135746, 10603295135753, and 10603295135760. Class II DePuy Orthopaedics, Inc. is voluntarily issuing a device correction for all lots of the ATTUNE® INTUITION" Tibial Articulation Surface Instruments used in trialing with the ATTUNE Knee System. The device correction is being issued due to the potential for the Balseal, which is a small wire spring coil located on the post feature of the Articulation Surface Instruments to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation. DePuy Orthopaedics, Inc.
Devices ATTUNE CONV RP PS TB TRL SZ10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components. Product Codes:254501000 and GTIN: 10603295135777 Class II DePuy Orthopaedics, Inc. is voluntarily issuing a device correction for all lots of the ATTUNE® INTUITION" Tibial Articulation Surface Instruments used in trialing with the ATTUNE Knee System. The device correction is being issued due to the potential for the Balseal, which is a small wire spring coil located on the post feature of the Articulation Surface Instruments to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation. DePuy Orthopaedics, Inc.
Devices ATTUNE CONV FB CR ARTICULATION SURFACE SZ1 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components. Product Codes:254500961 and 254500962. GTIN: 10603295135388 and 10603295135395. Class II DePuy Orthopaedics, Inc. is voluntarily issuing a device correction for all lots of the ATTUNE® INTUITION" Tibial Articulation Surface Instruments used in trialing with the ATTUNE Knee System. The device correction is being issued due to the potential for the Balseal, which is a small wire spring coil located on the post feature of the Articulation Surface Instruments to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation. DePuy Orthopaedics, Inc.
Devices ATTUNE CONV FB CR TB TRL SZ3 - 10 INTENDED USE: The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is attached to each of the two post features on the Articulation Surface to provide a connection force between the Tibial Articulation Surface and Shim to ensure secure engagement between the components. Product Codes:254501963, 254501964, 254501965, 254501966, 254501967, 254501968, 254501969, and 254501970. GTIN: 10603295423355, 10603295423362, 10603295423379, 10603295423386, 10603295423393, 10603295423409, 10603295423416, and 10603295423423. Class II DePuy Orthopaedics, Inc. is voluntarily issuing a device correction for all lots of the ATTUNE® INTUITION" Tibial Articulation Surface Instruments used in trialing with the ATTUNE Knee System. The device correction is being issued due to the potential for the Balseal, which is a small wire spring coil located on the post feature of the Articulation Surface Instruments to become damaged and disassociate (come off). If the Balseal is separated from the post, it has the potential to enter the surgical site and be left in the patient if the surgeon is unaware of the disassociation. DePuy Orthopaedics, Inc.
Cosmetics Centurion Medical Products Admission Kit, Code No. C1437 Batches & Expiration Dates: 2014040103, 2/28/2018; 2014021403, 3/31/2018; 014072203, 4/30/2018; 2014090203, 5/31/2018; 2014102303, 7/31/2018; 2015013003, 8/31/2018; 014121803, 12/31/2018; 2013012803, 1/31/2019; 013030503, 4/30/2019; 2013041103, 7/31/2019; 2013052103, 9/30/2019; 2013072503, 10/31/2019; 13082903, 12/31/2019; 013121803, 2/28/2019. Class II Products contain mouth wash which was recalled due to the presence of Psuedomonas aeruginosa. Centurion Medical Products Corporation
Cosmetics Centurion Medical Products, Mouth Care Kit, Code Nos. MC440, MC480, MC755, and MC830. MC440 & MC480 MOUTH CARE KIT, Batch numbers & Expiration Dates: 2013101790, Jan-16; 2013123090, Oct-15; 2014022790, Jan-16; 2014032190,Jun-16; 2014052290, Jun-16; 2014081190, Jun-16; 2014102290, Jun-16; 2014111090, Sep-16; 2015012290, Mar-17; 2015040690, Jun-16; 2012112690, Apr-15; 2012122490, Apr-15; 2013020590, Apr-15; 2013032690, Apr-15; 2013053090, Apr-15; 2013081490, Jan-16; 2013082290, Jan-16; 2013072390, Oct-15; 213101790 , Jan-16; 2013110890, Oct-15; 2013121790, Oct-15;  ...
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Class II Products contain mouth wash which was recalled due to the presence of Psuedomonas aeruginosa. Centurion Medical Products Corporation
Cosmetics Centurion Medical Products, Oncology Oral Kit, Code No. MC535 Batches & Expiration Dates: 2014010890, Jan-16; 2014121590,Mar-17 Class II Products contain mouth wash which was recalled due to the presence of Psuedomonas aeruginosa. Centurion Medical Products Corporation
Devices 0702-001-350Q, Diverter Valve Assembly 0702-001-000, Neptune 2 Rover Ultra (120V) 0702-001-000R, Repair Neptune 2 Rover 0702-002-000, Neptune 2 Rover Ultra (230V) 0702-002-000ES, Neptune 2 Rover (230V) Spanish 0702-002-000FI, Neptune 2 Ultra Rover (230V) Finnish 0702-002-000IT, Neptune 2 Rover (230V) Italian 0702-002-000R, Repair Neptune 2 Rover Ultra (230V) Product Usage: The Neptune 2 Waste Management System is intended to be used in the operating room, pathology, surgical centers, and doctor s offices to collect and dispose of surgical fluid waste as well as collect smoke generated from electro cautery or laser devices. Contraindication: connection of the Neptune 2 Waste Management System directly to chest tubes or other closed wound drains. The Stryker Neptune 2 Rover is a mobile unit used to suction, collect fluid waste, and evacuate surgical smoke from a surgical site during operation. Fluid waste is removed from the surgical site through suction tubing connected to inlet ports of disposable manifolds installed in the rover. The Diverter Valve Assembly consists of two diverter valves with three hoses, one inlet and two outlets. The sole purpose of the Diverter Valve Assembly is to direct/divert water from the fresh water inlet to either the large canister or small canister via the pre-fill tank. Serial Numbers ranging from 0803118093 through 1505400223; Distribution or Repair dates: November 1, 2011 to March 31, 2015 Class II Stryker Instruments is initiating a recall of the Neptune 2 Waste Management System due to complaints related to installation failures of the Neptune 2 diverter valve assembly during docking. Stryker Instruments Div. of Stryker Corporation
Devices Stryker SelectCore Variable Throw Biopsy Device, 14G, 10CM Product Usage: The Stryker SelectCore Variable Throw Biopsy Device is used in obtaining biopsy samples from soft tissues such as liver, breast, kidney, prostate, spleen, lymph nodes, and various soft tissue tumors. For breast biopsy this product is for diagnosis onlynot therapeutic use.. These devices are sterile, single use devices. Stryker Model Number: 0904-410-000; Lot# 61406001 Class II Stryker Instruments is recalling the Stryker SelectCore Variable Throw Biopsy Device due to the potential for for the stylet to eject from the SelectCore device during actuation. Stryker Instruments Div. of Stryker Corporation
Devices Ring Transjugular Intrahepatic Access Set Product Usage: The Ring Transjugular Intrahepatic Access Sets are intended for transjugular liver access in diagnostic and interventional procedures. The Ring Transjugular Intrahepatic Access Set consists of the following components: Flexor RTPS Guiding Sheath, needle, catheter, Dilator, Torcon NB Advantage Catheter, Van Andel Dilatation Catheter, Curved Newton Wire Guide, Amplatz Extra Stiff Wire Guide. Product Number: RTPS-100-10.0, Catalog Number G29769 Class II Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of the dilators being too long. Cook Inc.
Devices Flexor RTPS Guiding Sheath Product Usage: The Flexor RTPS Guiding Sheaths are intended for introduction of balloons, closed and non-tapered end catheters or other diagnostic and interventional devices. These curved sheaths are manufactured from material incorporating a stainless steel wire imbedded in the sheath shaft material with a soft tip and a Check-Flo® fitting at the proximal end. The sheath is accompanied by a dilator for access to the body as a catheter over the wire guide. Product Number: KCFW-10.0-35-RB-RTPS-100, Catalog Number G13081 Class II Cook Inc. is initiating a voluntary recall of the Ring Transjugular Intrahepatic Access Set and the Flexor RTPS Introduce Sheath due to complaints of the dilators being too long. Cook Inc.
Biologics Source Plasma 12200271605 Class II Blood product, collected from a donor who did not have a complete physical examination, was distributed. CSL Plasma, Inc
Biologics Source Plasma 12200261010, 12200254733, 12200233780, 12200232180, 12200225705, 12200221827, 12200210546, 12200209166, 12200199682, 12200196828, 12200189628, 12200170417, 12200163268 Class II Blood products, collected from a donor who did not have a complete physical examination, were distributed. CSL Plasma, Inc
Drugs Carb-O-Philic 40 Cream, 40%, a) 3 oz. tube (NDC 54162-640-03) b) 7 oz. tube (NDC 54162-640-07), Rx Only, Manufactured by Geritrex Corporation, Mount Vernon, NY 10550 a) Lot # 1502076; Exp. 08/16 b) Lot # 1502077,1503030; Exp. 08/16 Class III CGMP Deviation: Poor container closure of the bulk storage container Geritrex Corp
Devices Magnus Hybrid OR Table Column (1180.01B2) used in conjunction with Siemens Artis Zeego Angiography System. Maquet GmbH & Co. SN 00048 Class II There is a potential issue that could result to collision between the C-arm of the angiography system and the MAGNUS OR table system. After switching on the angiography-system, in rare cases, MAGNUS column provides wrong position data for the longitudinal movement leading to a collision. Maquet Cardiovascular Us Sales, Llc
Devices EVac 70 XTRA with Integrated Cable and PROcise EZ View with Integrated Cable Product Usage: PLASMA WAND devices are indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery including: adenoidectomy, cysts, head, neck, oral, and sinus surgery, mastoidectomy, myringotomy with effective hemorrhage control, nasal airway obstruction be reduction of hypertrophic nasal turbinates, nasopharyngeal/laryngeal indications including tracheal procedures, laryngeal polypectomy, and laryngeal lesion debulking, neck mass, papilloma keloids, submucosal palatal shrinkage, submucosal tissue shrinkage, tonsillectomy (including palatine tonsils), traditional uvulopalatoplasty (RAUP), tumors, and tissue in the uvula/soft palate for the treatment of snoring. It is intended for procedures using a conductive media, such as normal saline or Ringers lactate. Lot numbers 1093290 and 1091254 Class II Wands inspected with the adaptor fixture were released to the field not meeting the dielectric (Hipot) specifications. ArthroCare Corporation
Devices ARCHITECT c8000 System List Number 01G06-98 Product Usage: The Abbott ARCHITECT cSystem is intended for In Vitro diagnostic use only. It is designed to perform automated: chemistry tests, utilizing photometry and potentiometric technology. Serial Numbers: C802239, C802312, C802260, C802447, C801911 Class II The ARCHITECT c8000 instrument contains tubing that does not meet specifications and has the potential to leak. Abbott Laboratories
Devices Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series Tissue Expander is intended for temporary subcutaneous implantation and require periodic, incremental inflation with sterile saline for injection until the desired amount of tissue is developed. Serial No. (Lot No.) 11250691 (1030868), 11514564 (1107468), 11560447 (1120606), 14410441 (1745182), 14460177 (1752996), 14651643 (1782042), 14645258 (1781272), 14418851 (1747035), 14663483 (1784601), 14768174 (1800575), 11650852 (1146235), 11759596 (1175538), 11783801 (1181003), PX1195 (583159), VB9805 (1-116051), PG1537 (567007), PH8804 (569489), PK3108 (570078), PK3369 (570134), PK3381 (570134), PK6626 (570491), PK8403 (570651), PL0978 (570658), PL8893  ...
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Class II Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the product shipped was beyond the 47 month shelf life. Allergan Inc
Devices Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series Tissue Expander has been designed for temporary implantation to develop a skin flap. The device is used for reconstructive correction of a defect or to provide cover for a prosthetic implant. The CUI Tissue Expander consists of a silicone elastomer envelope and a remote injection port. Serial No. (Lot No.) VE7507 (5F075-OEM), VE9273 (6H009-OEM), VF4561 (09H024-OEM), VF5340 (10A115-OEM), VE9272 (6H009-OEM), VF3627 (09E231-OEM), VE9117 (6F158-OEM), VF1201 (7K195-OEM), VF5396 (10A182-OEM), VF5341 (10A115-OEM), VF4923 (09J052-OEM), VF1420 (7L085-OEM), VF1327(7L043-OEM), VE7508 (5F075-OEM), VF1427 (7L085-OEM), VE9274 (6H009-OEM). Class II Allergan is recalling the NATRELLE 133 and CUI Series Tissue Expanders because the products shipped were beyond the shelf life. Allergan Inc
Food Raw, Fresh, Farmed Chilean Atlantic Salmon -Atl Fs Sal Chilean Fill Tr D 3-4 lbs 40lbs -Atl Fs Sal Chilean Fill Deep Skinned Tr E 3-4 lbs 10LBS -Atl Fs Sal Chilean Fill Tr E 3-4 lbs 40lbs -Chilean Fresh Atl Trim D 1-6 Factory 40lbs -Chilean Fresh Atl Factory 1-6 SK off 40lbs -ATL Fs Sal Chilean Fill Skin off FFO 2-5lb 40lbs lot #700354 Item #: ATLFS00050, ATLFS00388, ATLFS00764, ATLFS20997, ATLFS20999 lot #700152 Item#: ATLFS00059, ATLFS00388, ATLFS00429, ATLFS0997, ATLFS20999, ATLFS20995 Class I Marine Harvest is recalling raw, fresh, farmed Chilean Atlantic salmon refrigerated salmon fillets due to potential Listeria monocytogenes contamination. Marine Harvest
Food Kirkland Signature Fresh Farmed Atlantic Salmon Fillet Product of Chile Processed in USA approx 2lbs. Packaged in a styrofoam tray and wrapped in plastic. Purchase dates of: 05/02-09/15 Item #: 30205 Class I Marine Harvest is recalling raw, fresh, farmed Chilean Atlantic salmon refrigerated salmon fillets due to potential Listeria monocytogenes contamination. Marine Harvest
Food Kirkland Signature Salmon Milano with Basil Pesto Butter approx 1.5 lbs. Packaged in a metal tray with plastic cover. Purchase dates of: 05/02-09/15 Item #: 40254 Class II Marine Harvest is recalling raw, fresh, farmed Chilean Atlantic salmon refrigerated salmon fillets due to potential Listeria monocytogenes contamination. Marine Harvest
Biologics Red Blood Cells Deglycerolized Leukocytes Reduced W117010233274M Class III Blood product, which did not meet the minimum requirement for Red Blood Cell recovery, was distributed. Blood Centers of the Pacific - Irwin Center
Devices Cochlear Nucleus Sterile Silicone Template Product Usage: The Cochlear Nucleus Sterile Silicone Template is used in the sterile field to check the size of the periosteal pocket, the shape and depth of the implant well and appropriate positions for tie down holes Lot numbers: COH471122 Expiration 5/6/15 and Lot COH471123 Expiration 4/24/15 Class II Cochlear Americas is recalling Nucleus Sterile Silicone Template CI24RE/CI422 part number Z421736 because expired product was distributed. Cochlear Americas Inc.
Biologics Platelets Pheresis Leukocytes Reduced W085514001824 Class II Blood product, which was labeled as leukoreduced, but was not tested to verify white blood cell count, was distributed. Central Blood Bank
Food Roseli Sundried Tomato Pesto sauce. #408744 (Dot Item) , # 627328 (Roseli item),3- 2 lbs tubs (poly) packed in corrugated shipper. Keep Frozen - Thaw under refrigeration. 5-19-2015 Class I Golden Plains Frozen Foods is recalling Roseli Sundried Tomato Pesto sauce due that the product is positive for Salmonella. No illnesses, injury or complaints reported due that the product was contained and it did not distributed to the consumer. Golden Plains Frozen Foods
Devices Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxial needle is used to obtain one or multiple core samples from soft tissue such as the liver, kidney, prostate, breast, etc. and is to be used in conjunction with an M-Biopsy Biopsy Needle for a Bard Magnum or Pro-Mag Biopsy Instrument. Lot No: P000290, P000360, P000230, P000291, P000299, P000148 Catalogue No: N20314010- N20320020 (for PRO-MAG Biopsy Instrument) Catalogue No: N20414010- N20420020 (for MAGNUM Biopsy Instrument) Class II Mermaid Medical A/S is recalling some of their M-Biopsy Coaxial Introducer Needles because of the potential for small plastic pieces to be present in the luer of the cannula. Mermaid Medical A/S
Devices Bone Marrow Aspiration Needle 15G x 2.688 MAX, Part Number DBMNI1501; Bone Marrow Aspiration Needle 15G x 4 MAX, Part Number DBMNI1504; Bone Marrow Aspiration Needle 16G x 2.688 MAX, Part Number DBMNI1601 Lot Numbers: 11088595, 11089104, 11089369, 11089370, 11094673, 11094679, 11095843, 11096115, 11098022, 11098023, 11098643, 11098707 Class II Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. Argon Medical Devices, Inc
Devices T-Lok Bone Marrow Biopsy Needle 8G x 4 Ext Can, Part Number DBMNJ0804TL; T-Lok Bone Marrow Biopsy Needle 11G x 4 Ext Can, Part Number DBMNJ1104TL; Bone Marrow Biopsy Needle 13G x 4, Part Number DBMNJ1304 Lot Numbers: 11088295, 11088596, 11088597, 11089105, 11089366, 11094182, 11094681, 11094912, 11095381, 11095844, 11095845, 11095951, 11096558, 11097278, 11097504, 11098024, 11098647, 11099173 Class II Potential defect in the forming of the primary package of the blister that may compromise the sterility of the product inside the tray. Argon Medical Devices, Inc
Devices Sureflex 150 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary). Model R-LLF150TG: All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Sureflex 200 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary). Model R-LLF200TG All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Sureflex 273 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary). Model R-LLF273TG All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Sureflex 365 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary). Model R-LLF365 All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Sureflex 550 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary). Model R-LLF550 All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Sureflex 910 Lithotripsy Fiber, 5x, Blue; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary). Model R-LLF910 All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices 200µM Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary). Model 8013046; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices 365µM Lithotripsy Fiber- Reusable; Sure F!ex laser fibers are intended for use in laser-based surgical applications, including, but not limited to endoscopic, laparoscopic and open surgical procedures involving vaporization, ablation, coagulation, hemostasis, excision, resection and incision of soft and cartilaginous tissue and surgical procedures involving vaporization, ablation and fragmentation of calculi (urinary and biliary). Model 8013056; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Fiber Stripper, 150µm, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 80-10001-003; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Fiber Stripper, 200µm, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 80-10001-003; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sure flex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Fiber Stripper, 273µm, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 80-10003-003; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sure flex'" Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Fiber Stripper, 365µm, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 80-10005-003; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Fiber Stripper, 550µm, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 80-10011-003; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Fiber Stripper, 910µm, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. ModelS0-10008-003; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Fiber Cleaver; Fiber Cleaver is also used to score the outer jacket on EndoStat Fibers (Aura XP) The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotripsy fiber and EndoStat fiber accessory. The Fiber Cleaver does not come in direct contact with the patient. Model 0010-0760; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices 1X1 Cleaving Tiles; The Fiber Cleaver is a reusable and sterilizable tool used to score the outer jacket on Endostat and SureFlex Fibers. The tool is a one piece pencil-like design with a sharpened blade at the end. The Fiber Cleaver is a SureFlex TM Reusable Laser Lithotripsy fiber and EndoStat fiber accessory. The Fiber Cleaver does not come in direct contact with the patient. Model 80-10007-001; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Tool, StripperW/BLD, 10S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 80-10001-001; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Tool, StripperW/BLD, 10S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 80-10001-002; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Tool, Stripper W/BLD, 12S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 80-10002-001; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Tool, Stripper W/BLD, 12S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 80-10002-002; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Tool, Stripper W/BLD, 14S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 80-10003-001; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Tool, Stripper W/BLD, 14S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 80-10003-002; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Tool, Stripper W/BLD, 18S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 80-1 0005-001; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Tool, Stripper W/BLD, 18S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 80-1 0005-002; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Tool, Stripper W/BLD, 44S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 80-10008-001; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Tool, Stripper W/BLD, 44S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 80-10008-002; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Tool, Stripper W/BLD, 28S, Nonautoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 80-10011-001; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Tool, Stripper W/BLD, 28S, Autoclavable; The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 80-10011-002; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Stripper, 0.6mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 0010-0751; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Stripper, 0.4mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 0010-0752; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Stripper, 0.3mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 0010-0754; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Devices Stripper, 0.2mm Disposable EndoStat Fiber, The Fiber Stripper is a tool provided for stripping the protective jacket off the end of an Endostat or SureFlex Fiber. The Fiber Stripper does not come in to direct contact with the patient. It is available in several sizes, corresponding to the Endostat or SureFlex Fiber core diameter size. Model 0010-0755; All product manufactured from April 8, 2012 to April 8, 2015 Class II validation data related to cleaning instructions and sterilization methods and the methods defined in instructions for use (IFU) for the Sureflex Reusable Fibers and the Reusable Stripper and Cleaver Accessories do not meet the new guidance on qualifying reusable products American Medical Systems Innovation Center - Silicon Valley
Cosmetics Centurion Fresh Rinse, Oral/Mouth rinse, 2 fl. oz. (59 ml), plastic bottle, 98 bottles per case. Lot # 8365 Product # AFR20 Class II Finding of Pseudomonas aeruginosa in finished product. Elba, Inc. dba Elba Laboratories
Cosmetics Centurion Fresh Rinse, Oral/Mouth rinse, 2 fl. oz. (59 ml), plastic bottle, 98 bottles per case. Lot # 8365 Product # AFR20 Class II Finding of Pseudomonas aeruginosa in finished product. Elba, Inc. dba Elba Laboratories
Food La Mexicana Spinach Dip Net Wt. 14oz. clear, plastic cup Product is packaged in plastic white container. Sell-by dates range from July 04 to August 29. Class II Milk is not declared as a sub-ingredient in the declared sour cream. Pages Produce Company Inc.
Devices THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1240 Product Usage: medical aspirator Serial Numbers 2639-2798 Class II Vacuum pump may not perform to specification. Gardner Denver Thomas Inc
Devices THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1242 Product Usage: medical aspirator Serial numbers 3831-4200 Class II Vacuum pump may not perform to specification. Gardner Denver Thomas Inc
Devices THOMAS by Gardner Denver, MEDI-PUMP(R) Aspirator, Model 1243 Product Usage: medical aspirator Serial numbers 2122-2629 Class II Vacuum pump may not perform to specification. Gardner Denver Thomas Inc
Devices GE Healthcare Precision 500D Classical R & F system. Mfg Lot or Serial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 ...
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Class II GE Healthcare has recently become aware of a potential safety issue with the single and dual LCD monitor suspensions used on Precision 500D Classical R & F system fluoroscopic imaging systems. GE Healthcare has recently become aware of a reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. There have been no injuries reported as a result of this issue. GE Healthcare
Devices GE Healthcare Precision RXi 23A/32A Analog System Mfg Lot or Serial # 00000001386MC2 00000002109MC7 00000001010MC8 00000001337MC5 00000002212MC9 00000001720MC2 00000001098MC3 00000001454MC8 00000001082MC7 00000001266MC6 00000001656MC8 00000003661MC6 Class II GE Healthcare has recently become aware of a potential safety issue with the single and dual LCD monitor suspensions used on Precision RXi 23A/32A Analog System fluoroscopic imaging systems. GE Healthcare has recently become aware of a reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. There have been no injuries reported as a result of this issue. GE Healthcare
Devices GE Healthcare Precision RXi Digital system Mfg Lot or Serial # 00000003510MC5 00000004082MC4 00000001524MC8 00000004565MC8 00000004022MC0 00000001590MC9 00000002033MC9 00000004021MC2 00000001528MC9 00000001975MC2 00000002235MC0 00000003739MC0 00000001147MC8 00000001280MC7 00000000953MC0 00000001645MC1 00000001319MC3 00000002255MC8 00000004585MC6 00000001473MC8 00000001292MC2 00000004110MC3 00000001354MC0 00000001744MC2 00000002104MC8 00000001020MC7 00000001093MC4 00000001429MC0 00000001453MC0 00000001407MC6 00000001388MC8 00000001374MC8 00000001296MC3 00000001652MC7 00000001381MC3 00000004024MC6 00000004160MC8 00000001380MC5 00000001969MC5 00000001100MC7 00000001170MC0 00000004108MC7 00000003844MC8 00000001288MC0 00000004702MC7 00000004703MC5 00000001394MC6 00000001527MC1 00000001428MC2 00000004597MC1 00000004027MC9 00000003966MC9 Class II GE Healthcare has recently become aware of a potential safety issue with the single and dual LCD monitor suspensions used on Precision RXi Digital system fluoroscopic imaging systems. GE Healthcare has recently become aware of a reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. There have been no injuries reported as a result of this issue. GE Healthcare
Devices GE Healthcare, Precision MPi fluoroscopic imaging systems. Mfg Lot or Serial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lass II GE Healthcare has recently become aware of a potential safety issue with the single and dual LCD monitor suspensions used on Precision MPi fluoroscopic imaging systems. GE Healthcare has recently become aware of a reported incident of a monitor that fell from the suspension. A fall of a monitor could result in an injury to a patient or operator. There have been no injuries reported as a result of this issue. GE Healthcare
Devices HardyCHROM VRE Agar-RSR Cat no: GA333 Lot no: H15055 Expires: 2015-07-04 Container type: 15x100mm monoplate Packaged: 10 plates/sleeve Storage 2 to 8 degrees C on receipt Chromogenic medium for stool pathogen screening. Cat No.: G333 Lot No.: H15055 Class II Hardy Diagnostics is recalling HardyCHROM VRE Agar due to lack of 510(k) clearance. Hardy Diagnostics
Devices Milex® Vaginal-Hymenal Silicone Dilators  Set of 4 P/N MX20 Product Usage: The CooperSurgical Milex® Vaginal-Hymenal Silicone Dilators are used for progressive vaginal dilation therapy involving the treatment of vaginismus (muscular spasm of the vagina) and conditions that result in constriction of the vaginal and/or rectal orifice LOT 156966 Class II Incorrect expiration date on outer carton kit label CooperSurgical, Inc.
Devices Infant Heel Warmer and Infant Gel Warmer, sold under the brand names CooperSurgical and Fisher brand as follows : CooperSurgical PN 20418 WARMGEL INFANT HEEL WARMER - PRISM BOX OF 100; PN 24401 LIQUID INFANT HEEL WARMER - PRISM BOX OF 100; and Fisher Brand. PN 24647 FISHERBRAND GEL INFANT - HEEL WARMER BOX OF 100; PN 24646 FISHERBRAND LIQUID INFANT - HEEL WARMER- 100 PER BOX All lot numbers Class II Product marketed without a 510(k) CooperSurgical, Inc.
Devices Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate the cheek subdermis in an elevated position. n/a. This action does not involve recall or correction of any device. Only marketing materials are being considered in this action Class II Silhouette Lift is recalling the Silhouette Suture brochure because it does not include a complete list of risks and side effects. Therefore, it can potentially mislead the patient regarding the safety of the product. Silhouette Lift, Inc.
Food Turkish Organic Diced Apricots with Rice Flour (5-7 mm), FOODIMPEX brand, Item# 17496, product is packged in a white cardboard box. Net wt. 28 lbs. Lot 106-T; Packing Date: February 2015 Class II Product found to contain rocks and metal. GloryBee Inc
Food All You Need Bread, Each loaf is package in a bag with a net wt. 1 lb. 14 oz., sold under brand Great Harvest Bread Co. None Class II All You Need Bread is recalled due to potential for contamination with foreign materials. Product contains diced organic dried apricots ingredient that was recalled by supplier. Buckwheat Enterprises, Inc
Devices The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular Device and the EkoSonic MACH4 Endovascular Device. The EkoSonic Endovascular System consists of three main components: -a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and -removable MicroSonic Device (MSD), and -a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, nonsterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device. CIC Serial Numbers: 19598-095, 19598-097, 19598-099, 19598-100, 19598-102, 19598-103, 19598-106, 19598-107, 19598-108, 19598-110, 19598-111, 19598-112, 19598-113, 19598-114, 19598-115, 19598-116, 19598-117, 19598-118, 19598-119, 19598-120, 19598-122, 19598-125, 19598-126, 19598-127, 19598-128, 19598-130, 19598-131, 19598-132, 19598-133, 19598-135, 19598-136, 19598-139, 19598-140, 19598-141, 19598-143, 19598-144, 19598-145, 19598-146, 19598-147, 19598-151, 19598-152, 19598-153, 19598-154, 19598-156, 19598-157, 19598-158. Class II The Connector Interface Cable (CIC) was not recognized by the EkoSonic PT-3B control unit. EKOS Corporation
Devices iovera 155 Smart Tip; Catalog numbers:STT0412-10 and STT0412-5 (10 and 5 count respectively) iovera Smart Tips are individually packaged in Tyvek PET pouches, which are then packaged into 5 or 10 쳌pack boxes and shipper boxes. Product Usage: Cyrogenic Surgical Device The myoscience iovera device is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The iovera device is not indicated for treatment of central nervous system tissue Catalog numbers:STT0412-­10 and STT0412-­5; Lot numbers : 1504021-­01 and 1505008. Class II The expiration date on the outer box label and the pouch label for the iovera Smart Tip product is incorrect. Myoscience Inc
Devices Volcano s5/s5i/CORE Intravascular Ultrasound Systems with software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature Model s5. Part numbers: 804200-002 and 804200-014 Class II During routine testing in-house, a software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. Volcano Corporation
Devices Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5x. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature Model s5x. Part number: 807300-001. Class II During routine testing in-house, a software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. Volcano Corporation
Devices Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Mobile. Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature Model CORE Mobile. Part number: 400-0100.01. Class II During routine testing in-house, a software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. Volcano Corporation
Devices Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5i Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature Model s5i. Part number: 806300-020. Class II During routine testing in-house, a software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. Volcano Corporation
Devices Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model s5ix/s5iz Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature Model s5ix/s5iz. Part number: 807400-001. Class II During routine testing in-house, a software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. Volcano Corporation
Devices Volcano s5/s5i/CORE Intravascular Ultrasound Systems software versions 3.3 and 3.4 (with and without iFR Scout Technology) and v.3.4 software kits; Model CORE Radiology: The Volcano s5/s5i and CORE Series Intravascular Imaging and Pressure System is used for the qualitative and quantitative evaluation of vascular morphology in the coronary arteries and vessels of the peripheral vasculature Model CORE. Part number: 400-0100.02. Class II During routine testing in-house, a software issue was discovered where an inaccurate FFR/iFR value could be calculated under certain circumstances. Volcano Corporation
Devices Pinnacle3 Software Version 9.0, 9.2, 9.4 and 9.6, Model Numbers 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451. 453560446041, 459800091001, 459800220161, 459800232931, 459800235871, 459800338451 Class II Philips, Pinnacle Radiation Treatment Planning System version 9 0, 9 2 9 4, 9 6 is being recalled because the dose may be inconsistent with the density of a density-overridden ROl. Philips Electronics North America Corporation
Devices GEMINI GXL 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Model #882410 GEMINI GXL 16 Slice (453567971891); Serial Number: 4170 & 4147A. Class II Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue. CT imaging displays both high-density tissue, such as bone, and soft tissue. PET uses radiopharmaceuticals to obtain images by measuring the internal distribution of radioactivity within organs of the body. PET technology enables the practitioner to reconstruct high-resolution, three-dimensional, images of biochemical and metabolic processes of organs within the body. Philips Medical Systems (Cleveland) Inc
Devices GEMINI LXL CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Model #882412 GEMINI LXL (459800018631); Serial Number: 14702 & 14707. Class II Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue. CT imaging displays both high-density tissue, such as bone, and soft tissue. PET uses radiopharmaceuticals to obtain images by measuring the internal distribution of radioactivity within organs of the body. PET technology enables the practitioner to reconstruct high-resolution, three-dimensional, images of biochemical and metabolic processes of organs within the body. Philips Medical Systems (Cleveland) Inc
Devices GEMINI TF 16 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Model #882470 GEMINI TF 16 Slice (453567983931); Serial Number: 7052, 7060, 7093, 7096, 7121, 7123, 7128, 7129, 7185, 7187, 7220, 7226 & 7570. Class II Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue. CT imaging displays both high-density tissue, such as bone, and soft tissue. PET uses radiopharmaceuticals to obtain images by measuring the internal distribution of radioactivity within organs of the body. PET technology enables the practitioner to reconstruct high-resolution, three-dimensional, images of biochemical and metabolic processes of organs within the body. Philips Medical Systems (Cleveland) Inc
Devices GEMINI TF 64 Slice CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Model #882471 GEMINI TF 64 Slice (453567994741); Serial Number: 7007, 7012, 7042, 7055, 7083, 7103, 7116, 7126, 7132, 7158, 7160, 7164, 7169, 7175, 7179, 7218, 7221, 7229, 7245, 7255, 7256 & 7552. Class II Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue. CT imaging displays both high-density tissue, such as bone, and soft tissue. PET uses radiopharmaceuticals to obtain images by measuring the internal distribution of radioactivity within organs of the body. PET technology enables the practitioner to reconstruct high-resolution, three-dimensional, images of biochemical and metabolic processes of organs within the body. Philips Medical Systems (Cleveland) Inc
Devices GEMINI TF Ready CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Model #882473 GEMINI TF Ready (453567441711); Serial Number: 7237. Class II Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue. CT imaging displays both high-density tissue, such as bone, and soft tissue. PET uses radiopharmaceuticals to obtain images by measuring the internal distribution of radioactivity within organs of the body. PET technology enables the practitioner to reconstruct high-resolution, three-dimensional, images of biochemical and metabolic processes of organs within the body. Philips Medical Systems (Cleveland) Inc
Devices GEMINI TF Base CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Model #882473 GEMINI TF Base (453567441711); Serial Number: 7111 & 7150. Class II Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue. CT imaging displays both high-density tissue, such as bone, and soft tissue. PET uses radiopharmaceuticals to obtain images by measuring the internal distribution of radioactivity within organs of the body. PET technology enables the practitioner to reconstruct high-resolution, three-dimensional, images of biochemical and metabolic processes of organs within the body. Philips Medical Systems (Cleveland) Inc
Devices GEMINI TF Big Bore CT/PET System. The Philips GEMINI PET/CT Imaging Systems are a family of integrated diagnostic X-ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems suitable for a wide range of diagnostic applications. Model #882476 GEMINI TF Big Bore (453567473391); Serial Number: 9004, 9005, 9006, 9008, 9009, 9010, 9011, 9012, 9013, 9014, 9015, 9016, 9017, 9018, 9019, 9020, 9021, 9022, 9023, 9201, 9202, 9203, 9204, 9205, 9206, 9207, 9208, 9209, 9210, 9211, 9212, 9214, 9215, 9216, 9217, 9219, 9220, 9221, 9222, 9223, 9224,  ...
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Class II Philips has identified four (4) software defects in the Tumor LOC software application that may potentially result in irradiation of healthy tissue or non-irradiation of diseased tissue. CT imaging displays both high-density tissue, such as bone, and soft tissue. PET uses radiopharmaceuticals to obtain images by measuring the internal distribution of radioactivity within organs of the body. PET technology enables the practitioner to reconstruct high-resolution, three-dimensional, images of biochemical and metabolic processes of organs within the body. Philips Medical Systems (Cleveland) Inc
Drugs Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-255-30 Lot # 3122833A, exp 5/13/16 Class III Failed dissolution specifications Purdue Pharma L.P.
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