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U.S. Department of Health and Human Services

Enforcement Report - Week of January 29, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices 1) The FEMTO LDV Z2 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea at constant depth relative to the corneal surface. 2) The FEMTO LDV Z4 Femtosecond Surgical Laser is an opthalmic surgical laser indicated for use in the creation of the corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that does not enclose a volume of the cornea. 3) The FEMTO LDV Z6 Femtosecond Surgical Laser is an ophthalmic surgical laser indicated for use in the creation of corneal incisions in patients undergoing LASIK surgery, tunnel creation for implantation of rings, pocket creation for implantation of corneal implants, lamellar keratoplasty or other treatment requiring lamellar resection of the cornea at a varying depth with respect to the corneal surface that may enclose a volume of the cornea. Serial Numbers: FLM4135, FLM3281, FLM2963, FLM3907, FLM3817 Class II A defect in the controller board can lead to the condenser to the video monitor becoming too warm. This could potentially cause the video monitor to shut off. Ziemer Usa Inc
Devices Oxoid Antimicrobial Susceptibility Test Discs, Cefpodoxime 10 mcg., CT1612B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes Lot 1275353, Exp. 31Dec2015 Class II Cartridges may contain individual discs which were not impregnated with antibiotic. Remel Inc
Devices Oxoid Antimicrobial Susceptibility Test Discs, Norfloxacin 10 mcg., CT0434B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes. Lot 1192177, Exp. Exp. 31May2015 Class II Cartridges may contain individual discs which were not impregnated with antibiotic. Remel Inc
Devices Oxoid Antimicrobial Susceptibility Test Discs, Ampicillin 10 mcg., CT0003B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in- vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes Lot 1215912, Exp. 31Jul2015 Class II Cartridges may contain individual discs which were not impregnated with antibiotic. Remel Inc
Devices Oxoid Antimicrobial Susceptibility Test Discs, Ertapenem 10 mcg., CT1761B, packaged in cartridges of 50 discs, 5 cartridges/pack. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes. Lot 1227786, Exp. 31AUG2013 Class II Cartridges may contain individual discs which were not impregnated with antibiotic. Remel Inc
Drugs Theraflu Flu & Sore Throat (acetaminophen 650 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Apple Cinnamon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7916-06, UPC 3 0043-0479-16 3. Also packaged under foreign label: NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Apple Cinnamon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05205 2. Lot #: 10115121, 10115832, Exp 5/31/2013; 10119854, 10119856, Exp 7/31/2013; 10122257, 8/31/2013; 10124286, 10124289, 10124292, Exp 9/30/2013; 10128103, 10128105, 10128108, 10128110, Exp 10/31/2013. NeoCitran Cold & Flu: 10115118, Exp 5/31/2013 and 10122252, Exp 9/30/2013. Class II Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. Novartis Consumer Health
Drugs Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Berry Infused with Menthol & Green Tea flavors, 6-count packets per carton, , Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-6257-06, UPC 3 0043-6257-06 2. Also packaged under foreign label: NeoCitran Extra Strength Daytime Total 7 Symptom Relief (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, dextromethorphan hydrobromide 20 mg) powder packets, Invigorating Berry with Green Tea flavor, 10-single dose pouches per carton, Novartis Consumer Health Canada Inc., Mississauga, ON, UPC 0 58478 10366 2. Lot #: 10115840, 10115888, Exp 5/31/2013; 10118946, 10118948, 10119864, 10119867, Exp 7/31/2013; 10122271, 10122297, 10124374, Exp 8/31/2013; 10122300, Exp 9/30/2013; 10124493, 10125910, 10128097, 10128099, 10128101, Exp 10/31/2013. NeoCitran Extra Strength Total 7 symptom relief: 10115129, Exp 5/31/2013; 10124152, Exp 8/31/2013; and 10124488, Exp 10/31/2013. Class II Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. Novartis Consumer Health
Drugs Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, and phenylephrine hydrochloride 10 mg), Berry Infused with Menthol & Green Tea flavors and Nighttime formula (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, and phenylephrine hydrochloride 10 mg), Honey Lemon Infused with Chamomile & White Tea flavors; packaged in a) 24-count packets per carton containing 6-count Daytime and 18-count Nighttime packets (UPC 3 0043-6403-24 7); b) 12-count packets per carton containing 6-count Daytime and 6-count Nighttime packets (UPC 3 0043-6403-12 4); Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Lot #: a) 25777303, 25777304, Exp 5/31/2013; 25777501, 25777502, Exp 6/30/2013; 25777801, 25777802, Exp 7/31/2013; 25777803, 25981801, 25981802, Exp 8/31/2013; 25981803, 26088801, 26088802, Exp 9/30/2013; b) 25596201, 25596202, 25596203, 25596204, 25596205, 25596206, Exp 5/31/2013; 25596207, 25767001, 25767101, 25767102, 25767103, Exp 6/30/2013; 25767002, 25767104, 25767105, 25767106, 25767201, Exp 7/31/2013; 25767202, 25767203,  ...
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Class II Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. Novartis Consumer Health
Drugs Theraflu (acetaminophen 325 mg, pheniramine maleate 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Natural Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, labeled as a) Theraflu Sinus & Cold (NDC 0067-6319-06, UPC 3 0043-6319-06 7) and b) Theraflu Cold & Sore Throat (NDC 0067-6716-06, UPC 3 0043-0467-16 0). Also packaged under foreign labels: NeoCitran Cold & Flu powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05009 6; and Theraflu Exthegran powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812904) and b) 10-count packets per carton (UPC 7 501124 814588), Distributed by Novartis Farmaceutica S.A. De C.V., Mexico Lot #: a) 10116014, Exp 6/30/2013; 10122246, Exp 7/31/2013; 10124322, Exp 9/30/2013; 10128122, Exp 11/30/2013; b) 10119852, Exp 7/31/2013; 10122249, Exp 8/31/2013; 10124321, Exp 9/30/2013; 10128118, Exp 11/30/2013; 10128120, Exp 11/30/2013. NeoCitran Cold & Flu: 10115576, Exp 6/30/2013; 10122243, Exp 8/31/2013 and 10124319, Exp 9/30/2013; Theraflu Exthegran 10115579, 10115572, Exp 6/30/2013;  ...
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Class II Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. Novartis Consumer Health
Drugs Theraflu Multi-Symptom Severe Cold (acetaminophen 500 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Green Tea & Honey Lemon flavors, packaged in a) 6-count packets per carton (NDC 0067-6426-06, UPC 3 0067-6426-06 8) and b) 1-count packet per card (NDC 0067-6426-01, UPC 3 0067-6426-01 3), Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Lot #: a) 10116016, Exp 6/30/2013; 10118931, Exp 7/31/2013; 10121950, Exp 8/31/2013; 10122314, 10122316, 10124226, Exp 9/30/2013; 10124377, 10124379, 10125916, 10128112, 10128114, Exp 10/31/2013; b) 25872801, Exp 7/31/2013 Class II Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. Novartis Consumer Health
Drugs Theraflu MAX-D Severe Cold & Flu (acetaminophen 1000 mg, dextromethorphan HBr 30 mg, guaifenesin 400 mg, pseudoephedrine HCl 60 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6427-06, UPC 3 0067-6427-06 5. Also packaged under foreign label: NeoCitran Extra Strength Total 7 Symptom Relief Plus Mucous Relief powder packets, Soothing Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 10701 1. Lot #: 10089568, Exp 5/31/2013; 10093324, 10094745, 10097626, 10097627, Exp 7/31/2013; 10098588, Exp 9/30/2013. NeoCitran Extra Strength Total 7 Symptom Relief Plus Mucous Relief : 10093316, Exp 7/31/2013; 10098591, Exp 9/30/2013; 10101027, Exp 10/31/2013; 10102623, Exp 11/30/2013; 10106813, Exp 1/31/2014; 10115844, Exp 6/30/2014; 10124363, Exp 9/30/2014. Class II Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. Novartis Consumer Health
Drugs Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6318-06, UPC 3 0043-6318-06 0. Lot #: 10116040, Exp 6/30/2013; 10119871, Exp 7/31/2013; 10122275, Exp 9/30/2013. Class II Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. Novartis Consumer Health
Drugs Theraflu Flu & Chest Congestion (acetaminophen 1000 mg and guaifenesin 400 mg) powder packets, Natural Citrus flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-0483-06, UPC 3 0043-0483-06 1. Lot #: 10115134, Exp 5/31/2013; 10119862, Exp 7/31/2013; 10122276, 10124325, Exp 10/31/2013. Class II Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. Novartis Consumer Health
Drugs Theraflu Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon Infused with Chamomille & White Tea flavors, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-6256-06, UPC 3 0043-6256-06. Also packaged under foreign label: NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, diphenhydramine hydrochloride 25 mg, Soothing Honey Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., UPC 0 58478 10594 9. Lot #: 1011525, 10115834, Exp 5/31/2013; 10116012, 10116043, 10116045, 10116047, 10116049, 10117462, 10118936 Exp 6/30/2013; 10118683, 10118685, 10118934, 10118938, Exp 7/31/2013; 10122278, 10122280, 1012282, Exp 8/31/2013; 10124331, 10124333, 10124335, 10125908, Exp 9/30/2013; 10125923, 10126909, 10126911, 10127023, 10127026, Exp 10/31/2013. NeoCitran Extra Strength Sugar Free Total 7 Symptom Relief: 10116036, Exp 6/30/2013  ...
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Class II Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. Novartis Consumer Health
Drugs NeoCitran Extra Strength (acetaminophen 650 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 20mg, chlorpheniramine maleate 4 mg, ascorbic acid 5 mg) powder packets, Soothing Lemon flavor, 10-single dose pouches per carton, Novartis Consumer Health Canada Inc., Mississauga, ON, labeled as a) NeoCitran Extra Strength Nighttime Total 7 Symptom Relief (UPC 0 58478 10063 0) and b) NeoCitran Extra Strength Cough, Cold & Flu (UPC 0 58478 47363 5). Lot #: a) 10094895, Exp 7/31/2013; 10098586, Exp 9/30/2013; 10104820, Exp 12/31/2013; 10109982, Exp 2/28/2014; 10110876, Exp 3/31/2014; 10114393, Exp 5/31/2014; 10119851, Exp 7/31/2014; 10122313, Exp 9/30/2014; b) 10097661, Exp 8/31/2013; 10099912, Exp 9/30/2013; 10105539, Exp 12/31/2013; 10109980, Exp 2/28/2014; 10114396, Exp 5/31/2014; 10119849, Exp 7/31/2014; 10122312, Exp 9/30/2014. Class II Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. Novartis Consumer Health
Drugs NeoCitran (acetaminophen 1000 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 30 mg, chlorpheniramine maleate 4 mg) powder packets, Natural Source Cherry flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, labeled as a) NeoCitran Ultra Strength Total Flu 7 Symptom Relief (UPC 0 58478 47365 9) and b) NeoCitran Extra Strength Sore Throat & Cough (UPC 0 58478 47365 9). Lot #: a) 10112236, Exp 4/30/2014 and 10122295, Exp 9/30/2014; b) 10093319, Exp 6/30/2013 and 10100417, Exp 9/30/2013. Class II Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. Novartis Consumer Health
Drugs NeoCitran Extra Strength Cold & Flu (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga , ON, UPC 0 58478 05103 1. Also packaged under foreign labels: Theraflu Extra Cold and Flu powder packets, Lemon flavor, 10-count packets per box, UPC 4 607045 191395 (Russia and Former Soviet Union product); Theraflu Nighttime Severe Cold powder packets, Natural Lemon flavor, 6-count packets per carton, Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, UPC 8 806536 013925 (Korea product); Lot #: 10113888, Exp 5/31/2013; 10118944, Exp 6/30/2013; 10120024, Exp 9/30/2013; 10124381, Exp 10/31/2013. Russia product: 10112623, 10112625, 10112627, 10112629, 10112631, 10112633, Exp  ...
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Class II Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. Novartis Consumer Health
Drugs NeoCitran DM Cough & Cold (dextromethorphan hydrobromide 30 mg, phenylephrine hydrochloride 10 mg, pheniramine maleate 20 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05503 9. Lot #: 10122293, Exp 8/31/2013. Class II Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. Novartis Consumer Health
Drugs NeoCitran Extra Strength Non-Drowsy Cold & Sinus (acetaminophen 650 mg and phenylephrine hydrochloride 10 mg) powder packets, Natural Source Lemon flavor, 10-count single dose pouches per carton, Novartis Consumer Health Canada, Inc., Mississauga, ON, UPC 0 58478 05703 3. Also packaged under foreign label: Theraflu Daytime Severe Cold powder packets, Natural Lemon flavor, 6-count packets per carton, Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-7116-06, UPC 8 806536 01402 1 (Korea Product) Lot #: 10116030, Exp 6/30/2013. Korea product: 10112972, Exp 5/31/2013 and 10116032, Exp 7/31/2013. Class II Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. Novartis Consumer Health
Drugs Theraflu Exte (dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 20 mg, chlorpheniramine maleate 10 mg) powder packets, lemon flavor, packaged in a) 6-count packets per carton (UPC 7 501124 812881) and b) 10-count packets per carton (UPC 7 501124 814595), Distributed by Novartis Farmaceutica, S.A., DE C.V., Mexico. Lot #: a) 10119730, Exp 9/30/2013; b) 10115568, 10115570, Exp 6/30/2013; 10119728, Exp 9/30/2013. Class II Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. Novartis Consumer Health
Drugs Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 mg) powder packets, Forest Berries flavor, 10-count packets per box, UPC 4 607045 191760. (Russian product and Former Soviet Union product) Lot #: Russia product: 10117513,10117515, 10117517, 10117520, 10118676, 10118680, Exp 6/30/2013 and Former Soviet Union product: 10116986, 10116988, Exp 8/31/2013. Class II Presence of Foreign Substance: The products are being recalled because they may contain foreign substances. Novartis Consumer Health
Drugs Cubicin (daptomycin for injection), 500 mg lyophilized powder, 10 mL single-use vials, Rx only, Manufactured for Cubist Pharmaceuticals, Inc., Lexington, MA Lot Numbers: Lot 950453F, Exp. 12/06/2013 Lot 090203F, Exp. 09/07/2014 Lot 201703F, Exp. 08/31/2015 Lot 201653F, Exp. 09/01/2015 Class I Presence of Particulate Matter; Glass particulates observed in vials Cubist Pharmaceuticals, Inc.
Devices VITROS Chemistry Products COCM Reagent Product Code: 6801995; Lot numbers: 1) 1525-09-2754 Exp Date: 1 Nov 2013, 2) 1525-10-2091 Exp Date: 1 March 2014, 3) 1525-10-3062; Exp Date: 1 April 2014 Class II Ortho Clinical Diagnostics issued a Product Correction Notification for VITROS Chemistry Products COCM Reagent due to inaccurate quality control results. Ortho-Clinical Diagnostics
Devices TRUFILL® n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System; Two 1 g tubes of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-400; The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. All lot codes Class I Incorrect instructions for use (IFU). Codman & Shurtleff, Inc.
Devices TRUFILL® n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g tube of n-BCA, one 10 mL vial of Ethiodized Oil and one 1 g vial of Tantalum Powder Product Code: 631-500 The TRUFILL n-BCA Liquid Embolic System is indicated for the embolization of cerebral arteriovenous malformations (AVMs) when pre-surgical devascularization is desired. The system is used under fluoroscopic guidance to obstruct or reduce blood flow to cerebral arteriovenous malformations (AVMs) via superselective catheter delivery. All lot codes Class I Incorrect instructions for use (IFU). Codman & Shurtleff, Inc.
Devices Civco Belly Board, Reusable non-sterile carbon fiber belly board with cushion, REF 125012, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region. Lot #'s: M441670, M469970, M469980, M469990, M484910, M484920, M516200, M516210, M516220, M533340, M533350, M533360, M533370, M533380, M533970, M533980, M533990, M534000, M544650, M544660, M544670, M550150, M551490, M554940, M554950, M556540, M556550, M559560, M560740, M575850, M578310, M581730, M591090, M591100, M591110, M591120, M591130, and M599570 Class II Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other. Civco Medical Instruments Inc
Devices Civco Belly Board MRI, Reusable non-sterile glass fiber belly board with cushion, REF 126000, packaged 1 per box. Product Usage: This device is intended to reduce the irradiated small bowel volume of gynecological patients undergoing treatment in the pelvic region. Lot#'s: M551490 and M550150 Class II Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other. Civco Medical Instruments Inc
Drugs Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only. Mfd by: Fresenius Kabi USA, LLC Packaged under two labels: 1) Mfd for: APP Pharmaceuticals, LLC; Schaumburg, IL 60173, NDC 63323-563-10, and 2) Mfd in USA; for Nexus Pharmaceuticals Inc; Vernon Hills, IL 60061. NDC 14789-500-10. National Drug Code (NDC): 63323-563-10; Lot Numbers and (Expiration Dates): 011713 (01/2015); 012213 (01/2015), 032913 (03/2015), 041613 (04/2015); 042513 (04/2015), 042613 (04/2015), 052213 (05/2015), 092612 (09/2014), 111512 (11/2014) NDC: 14789-500-10; 122911 (12/2013), 123011 (12/2013) Class II Presence of particulate matter consistent with delamination of the glass vial container. Fresenius Kabi USA, LLC
Drugs sertraline HCl tablets, 25 mg, 30 Tablets, Rx only, GREENSTONE BRAND --- Distributed by: Greenstone LLC, Peapack, NJ 07977 -- MADE IN INDIA --- NDC 59762-4960-1 Lot SASA12001-A, exp. date 06/2015; Lot SASA12001-B, exp. date 06/2015; Lot SASA13001-A, exp. date 02/2016; Lot SASA13002-A, exp. date 02/2016 Class II Labeling: Incorrect or Missing Lot No. and/or Exp Date: Expiration date incorrectly reflects a 36 month shelf life, instead of the 24 month shelf life Greenstone LLC
Biologics Platelets Pheresis Leukocytes Reduced W115113288748A; W115113288746E Class II Blood products, with a low platelet counts, were distributed. LifeSouth Community Blood Centers, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W115113260468X Class II Blood Product, which did not meet specifications, were distributed. LifeSouth Community Blood Centers, Inc.
Biologics Red Blood Cells W227713042574 Class II Blood product, collected from a donor who traveled to a malarial endemic area, was distributed. Mid-South Regional Blood Center
Biologics Plasma Frozen within 24 hours (FP24) W038113125686; W038113174337; W038113162647; W038113113880; W038113161099; W038113165125; W038113165121; W038113165124; W038113161103; W038113161663; W038113125688; W038113146701; W038113125689 Class III Blood Products, in which component preparation/component were not prepared in accordance with specifications, were distributed. OneBlood, Inc.
Biologics Blood and Blood Products for Reprocessing W088413529943 Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. Blood Bank Of Hawaii
Biologics Blood and Blood Products for Reprocessing 004FC72018 Class III Blood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed. Arc Blood Services, New England Region
Biologics Source Plasma 2010363701; 2010363208; 2010362156; 2010361554; 2010361279 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. PlasmaCare, Inc.
Biologics Platelets Pooled Leukocytes Reduced W037913564403 Class II Blood products, collected from a donor who traveled to a malarial endemic area, were distributed. LifeServe Blood Center
Biologics Blood and Blood Products for Reprocessing W035410046738; 8550379 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Community Blood Center
Devices Zimmer Segmental Systems; Polyethylene Inserts, Size B. Designed to address significant bone loss resulting from oncology, trauma, and/or salvage of previously failed arthroplasty. Part numbers 00-5850-012-95 Class II After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert. Zimmer, Inc.
Devices Zimmer Segmental Systems; Polyethylene Inserts, Size C. Knee replacement. Part numbers 00-5850-013-95 Class II After evaluation of 13 complaints(0.4% rate) for hyper-extension of the Zimmer Segmental System, Zimmer is updating the related surgical technique and instructions for use to provide additional instructions and patient conditions that may place excessive loading on the polyethylene insert. Zimmer, Inc.
Devices ABL90 FLEX Analyzer Radiometer Medical ApS, Åkandevej 21 Brønshøj, Denmark A portable, automated analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. Lot R0375N009, Model #393-090, S/N 393-090R0027N001 - 393-090R0379N010 Class II RADIOMETER become aware that if the ABL90 FLEX is tilted, this may potentially cause a negative bias on sodium (Na+) results. Radiometer America Inc
Drugs Fluconazole Oral Suspension, 10 mg/mL, 35 ml bottle, RX only, Mfd by Cipla, Ltd., Goa, India, Dist by Teva Pharmaceuticals USA, Inc., Sellersville, PA. NDC: 0093-5414-95. Lot: (Exp); V10316 (11/13), V10317 (11/13), V10320 (11/13), V10321 (11/13), V20086 (2/14), V20087 (2/14), V20089 (2/14), V20093 (2/14), V20094 (2/14), V20086 (2/14), V20118 (3/14), V20119 (3/14), V20147 (3/14), V20148 (3/14), V20152 (4/14), V20154 (4/14), V20155 (4/14), V20180 (4/14), V20181 (4/14), V20182 (4/14), V20203 (5/14), V20204 (5/14), V20233 (5/14), V20234 (5/14), V20273  ...
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Class III Failed stability testing; this product is below specification for preservative content. Teva Pharmaceuticals USA, Inc.
Devices BD GeneOhm Cdiff Assay, Part #441401, containing Lysis Kit sample buffer tubes, 200 tests/kit; labeled as ***GeneOhm Sciences Canada, Inc. 2555 boul. du Parc-Technologique Quebec, Qc, Canada, G1P 4S5*** The BD GeneOhm" Cdiff Assay is a rapid in vitro diagnostic test for the direct, qualitative detection of C. difficile toxin B gene (tcdB) in human liquid or soft stool specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test, based on real-time PCR, is intended for use as an aid in diagnosis of CDAD. Lot 08T13108 Exp Dec 24 2013 Class II An incorrect reagent was packed with an in vitro diagnostic kit, which may cause an increase in unresolved results or false negative results for Clostridium difficile in patient samples. Becton Dickinson & Co.
Food Heavenly Blue, (Raw milk, salt, culture, coagulant ), Flat Creek Lodge, 367 Bishop Chapel Church Rd, Swainsboro, GA 30401. The raw milk blue cheese is packaged in clear plastic, with sizes ranging from 1/2 lb to whole wheels. Lot Code: 130912XHB Class I Product was found to be contaminated with Salmonella. Flat Creek Farm & Dairy
Devices MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 0603880. Product Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort Implanted Port Kits These products are used for patient therapies requiring repeated access to the vascular system. They are indicated for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. Subject ports are not indicated to Power Injection. Port access is performed by percutaneous needle insertion using a non-coring needle. The system consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque silicone catheter. Lot REXC0931 and REXC0736 Class II Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labeling for the device. Bard Access Systems
Devices Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr Catheter. Product Code 0602180 Usage: The 6.6 Fr Open-Ended Single-Lumen venous catheters is packaged into various Bard Acess Systems finished goods as Attachable or Preconnected catheters in BardPort Implanted Port Kits These products are used for patient therapies requiring repeated access to the vascular system. They are indicated for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. Subject ports are not indicated to Power Injection. Port access is performed by percutaneous needle insertion using a non-coring needle. The system consists of two primary components: an injection port with a self-sealing silicone septum and a radiopaque silicone catheter. Lot REXC0467 Class II Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single Lumen Broviac Catheter because a small number of Silicone catheters in the may be undersized to 5.3 Fr instead of 6.6 Fr as stated in the labeling for the device. Bard Access Systems
Devices Medrad Veris MR Monitor units The system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional healthcare provider. Physiological data, gas monitoring, system alarms, and patient analysis will be available to the care provider from the monitor. P/N 301641, Catalog #s 3011992, 3011992W, 3011993, 3011993W, 3011994, 3011994W, 3011996, 3011996W, 3014268, 3014268W, with multiple serial numbers. Class II The main board, P/N 301641, installed in some Medrad Veris MR Monitor units may be faulty and could lead to unexpected shutdown of the system while in use, resulting in the loss of vital signs information from the monitor. Medrad Mr Inc
Biologics Red Blood Cells Leukocytes Reduced W045013051168 Class II Blood product, collected from a donor who may have traveled to a malarial endemic area, was distributed. Community Blood Center Of Gtr KC
Biologics Red Blood Cells Leukocytes Reduced W045013021918; W045013051172 Class II Blood products, collected from a donor who may have traveled to a malarial endemic area, were distributed. Community Blood Center Of Gtr KC
Biologics Source Plasma 41501483911; 41501455030; 41501477722 Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. Csl Plasma Inc
Biologics Source Plasma JB0359632; JB0360524 Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. DCI Biologicals, LLC
Devices ORCHESTRA/ORCHESTRA PLUS Programmer ORCHESTRA/ORCHESTRA PLUS Programmer implanted with the following pacemaker models. - REPLY Models D, DR, VDR, SR - ESPRIT Models D, DR, S, SR - FACIL Model DR1 Class II Sorin has voluntarily issued a notification to physicians related to the overestimation of the residual longevity displayed by its programmer (ORCHESTRA or ORCHESTRA PLUS) during a follow-up exam of patients implanted with a REPLY or ESPRIT pacemaker. Sorin Group Italia S.r.l.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W050913056612 Class II Blood products, which did not meet the acceptable product specifications, were distributed. HCSC-Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W050913056612 Class II Blood products, which did not meet the acceptable product specifications, were distributed. HCSC-Blood Center
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W072113001849 Class II Blood product, which did not meet the acceptable product specifications, was distributed. Southern California Permanente Medical Group
Devices Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that can run tests on human serum, plasma, or urine. ADVIA 1200 with software versions: V2.00 and V2.01 ADVIA 1650 with software versions V3.52 and V4.01 Class II An overflow flag //// is displayed in the result column for a test when the algorithm for the test cannot calculate a result or when the concentration cannot be determined because it is outside the absorbance limits, and it is possible for the user to misinterpret or edit the result. Siemens Healthcare Diagnostics, Inc.
Biologics Blood and Blood Products for Reprocessing W20291302243900 Class II Blood products, collected from a donor who may be at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. American Natl Red Cross Mid Atlantic Region
Devices DRX-Evolution with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. Service Code: 7171 Class II Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement. Carestream Health, Inc.
Devices DRX-Evolution with CSH WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. Catalog Numbers: 1731678, 1731660, 1010990, 1030451, 1016138, 1030477, 1010982, 1030485; Service Code: 7171 Class II Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement. Carestream Health, Inc.
Devices DR 7500 with FF WS These products are permanently installed diagnostic x-ray systems composed of 4 main components: an operator console, over head tube crane, x-ray tube assembly including a collimator and stationary generator. In addition the device can use an x-ray table and /or wallstand/bucky to complete x-ray exposures. The DRX-Evolution system is a permanently installed diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. Catalog Numbers: 8551046, 8791345, 1333483, 8649253, 8864605, 1155118, 1295088, 1666700, 1845122, 1671841, 8245607, 8531675, 8966780; Service Code: 8087 Class II Carestream Health Inc. has issued a recall for the Carestream DRX-Evolution (FF WS and CSJ WS) and the Kodak DirectView DR 7500 System due to the potential for unexpected device movement. Carestream Health, Inc.
Devices Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista System. Measurements are used as an aid in the management of heart, liver, and kidney transplant patients. lots 12300BB, exp. 10-26-2013; 12318BB, exp. 11-13-2013; and 13011BB, exp. 1-11-2014. Class II Complaints were received regarding variability in recovery of QC and patient results with certain lots of the Dimension Vista CSA Flex reagent cartridges. Siemens Healthcare Diagnostics, Inc.
Devices XiO RTP System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on-screen and in hard-copy, either two or three-dimensional radiation dose distributions within a patient for a given treatment plan set-up. Model or Catalog No. MUJ; Software Version XiO Versions 4.80 and higher Class II When the number of fractions is changed for a proton spot beam, the MU are recomputed and rounded if necessary, but the dose is not recalculated as it should be even after saving and re-opening the plan. Elekta, Inc.
Devices GE Healthcare, Dash 3000, Dash 4000 and Dash 5000. Product Usage: The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. K073462: The Dash 3000/4000/5000 patient monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash 3000/4000/5000 patient monitor is designed as a bedside, portable, and intra-hospital transport monitor that can operate in all professional medical facilities including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, free-standing surgical centers, and other alternate care facilities. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, inoninvasive blood pressure, heart rate, temperature, cardiac output, respiration, pulse oximetry, carbon dioxide, bi-spectral index, impedance cardiography, oxygen, and anesthetic agents as summarized in the operators manual. The Dash 3000/4000/5000 patient monitor is also intended to provide physiologic data over the UNITY NETWORK indirectly to clinical information systems (via our Enterprise Gateway) and allow the user to access hospital data at the point-of-care. The information can be displayed, trended, stored, and printed. The Dash 3000/4000/5000 patient monitor was developed to interface with nonproprietary third party peripheral devices that support serial data outputs. K992929: The Dash 3000 Patient Monitoring System is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of the system is to monitor physiologic parameter data on adult, pediatric and neonatal patients. The Dash is designed as a bedside, portable, and transport monitor that can operate in all professional medical facilities and medical transport modes including but not limited to: emergency department, operating room, post anesthesia recovery, critical care, surgical intensive care, pediatric intensive care, or neonatal intensive care areas located in hospitals, outpatient clinics, freestanding surgical centers, and other alternate care facilities, intra-hospital patient transport, inter-hospital patient transport via ground vehicles (i.e. ambulance, etc.) and fixed and rotary winged aircraft, and prehospital emergency response. Physiologic data includes but is not restricted to: electrocardiogram, invasive blood pressure, noninvasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, and carbon dioxide as summarized in the operators manual. The Dash 3000 Patient Monitoring System is also intended to provide physiologic data over the Unity network to clinical information systems and allow the user to access hospital data at the point-of-care. This information can be displayed, trended, stored, and printed. F1DJ2018G H9DJ0236G E1DJ0384G SBG06398779GA A3DJ4203G J2DJ8331G SBG06182479GA SBG06192680GA F2DJ5762G DSH04532005GA G1DJ2217G E2DJ3710G M3EH8966GR L0DJ5294G SBG05463469GA SBG06264541GA M2DJ2447G J3EH5175G L2DJ1220G B0DJ1561G SD007293609GA L2DJ1263G C1DJ8662G A4EH1258G F0DJ3308G SBG06046629GA SD007262789GA AAB04254355GA SD008429849GA B2DJ1915G DSH05293139GA SD008138223GA H9DJ0155GR SD007251995GA H1DJ3351G SBG06046550GA F2DJ5089G DSH05185989GA H2DJ7244G F1DJ1599G M1DJ7820G DSH05318073GA M2DJ3629G L1DJ6712GR D2DJ2937GR K0DJ5004GR SD007335572GA AAB04231070GA H2DJ7075G K1DJ5436G  ...
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Class II GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance. GE Healthcare, LLC
Devices SOLAR 8000 AND TRANSPORT PRO WITH PATIENT DATA MODULE (Marketed As GE Healthcare CARESCAPE Patient Data Module) Product Usage: The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. The Solar 8000i with Patient Data Module/Transport Pro with Patient Data Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as hospital, clinic, surgical center or doctors office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), chest pain clinic, general intensive care unit (ICU), critical care unit, surgical intensive care unit (SICU), respiratory intensive care unit, coronary care unit (CCU), medical intensive care unit (MICU), pediatric intensive care unit (PICU), or neonatal intensive care unit (NICU). The Patient Data Module (PDM) is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the PDM includes ECG, invasive pressure, non-invasive blood pressure, pulse oximetry, temperature, cardiac output nad respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes. The Transport Pro patient monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Patient Data Module (PDM) or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive pressure, noninvasive blood pressure, pulse oximetry, temperature and respiration. Both the PDM and TRAM acquisition module acquire, process and store information for all aforementioned parameters. The Solar 8000i patient monitoring system is a multi-parameter physiological patient monitoring system intended for use on adult, pediatric and neonatal patients. It provides uninterrupted monitoring of physiological patient data. The Solar 8000i patient monitoring system is capable of monitoring and analyzing the following parameters for all patient populations: Electrocardiogram, invasive pressure, non-invasive blood pressure, pulse, temperature, cardiac output, respiration, pulse oximetry, venous oxygen saturation, transcutaneous pO2 and pCO2, CO2 and respiratory mechanics. The Solar 8000i patient monitoring system is capable of GE Healthcare Page 3 of 6 monitoring the following parameters for adult and pediatric patient populations: anesthetic agent concentrations, O2, impedance cardiography, electroencephalography and bispectral index. The Solar 8000i patient monitoring system interfaces with a variety of third-party peripheral medical devices that support serial and /or analog data outputs. Information from these devices can be displayed, trended and stored in the monitoring system. The solar 8000i patient monitoring system also provides physiological data over the Unity Network. SA308044521GR SA308186360GA SA310444859GA SA308186380GA SA312091241GA SA308491207GA SA308186401GA SA308186385GA SA308186374GA SA308155957GA SA308186391GA SA308186366GA SA308186410GA SA308094871GA SA308094818GA SA308186445GA SA308186381GA SA312479810GA SA308094940GA SA308094803GA SA308094872GA SA308084770GA SA310528992GA SA310506733GA SA310506696GA SA311153223GA SA311142931GA SA312080647GA SA312080894GA SA308186396GA SA308166121GA SA308186397GA SA308094807GA SA308186404GA SA311153169GA SA308186377GA SA308398894GA SA312253398GA SA308094809GA SA309263954GA SA310048616GA SA309527962GA SA310038386GA SA310048604GA SA310048613GA SA310028273GA SA310038462GA SA308317172GA SA311184814GA SA309365237GR  ...
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Class II GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance. GE Healthcare, LLC
Devices GE Healthcare, TRAM MODULE, High-acuity patient monitoring. Product Usage: The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. K900540: TRAM modules are intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The intended use of TRAM modules is to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. The TRAM module functions as a transport monitor during transport, and in the bedside monitor during ICU or OR monitoring. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. TRAM modules acquire, process and store information regarding these parameters. TRAM modules incorporate different monitoring capabilities based on their configuration. K011000: The TRAM 2001 Module is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The TRAM 2001 Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric, and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. During non-transport monitoring, the TRAM 2001 Module functions in the bedside monitoring system. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature, and respiration. The TRAM 2001 Module acquires, processes and stores information regarding these parameters. The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctors office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport. K053121: The TRAM Module is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in its proper use. The TRAM Module is intended to provide uninterrupted monitoring of physiologic parameter data on adult, pediatric and neonatal patients during transport from one area of the hospital or facility, and monitoring system, to another. During non-transport monitoring, the TRAM Module functions in the bedside monitoring system. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and respiration. The TRAM Module acquires, processes and stores information regarding these parameters. The device is intended for use in a professional medical facility, such as hospital, clinic, surgical center or doctors office. The TRAM System can be used in multiple areas such as operating room (OR), post anesthesia recovery (PARR), critical care, surgical intensive care, pediatric intensive care, or neonatal intensive care. The device is intended for use as part of a transport monitoring system for intra-hospital transport. C7HA1686G C7HA1700G C7HA1701G C7HA1696G C7HA1692G C7HA1688G C7HA1691G C7HA1689G C7HA1687G C7HA1702G B7HA1657G C7HA1683G C7HA1703G C7HA1707G C7HA1709G C7HA1711G D8HA3141G D8HA3154G D8HA3135G D8HA3136G D8HA3149G D8HA3148G D8HA3128G D8HA3134G D8HA3152G D8HA3140G D8HA3137G D8HA3144G H3S20070G H3S20072G J3S20073G J3S20075G J3S20078G J3S20084G J3S20089G J3S20090G J3S20093G J3S20085G A4S20482G A4S20471G G4S21111G G4S21108G G4S21112G G4S21090G G4S21106G F5HB0489G E5HB0418G F5HB0493G F5HB0491G F5HB0468G  ...
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Class II GE Healthcare has recently become aware of a potential safety issue due to intermittent noise on ECG and/or Respiration waveforms associated with movement of the ECG connector on your DASH, PDM, and/or Tram Module. ECG and Respiration signal noise caused by DASH, PDM, and/or Tram ECG cable connector movement may result in reduced ECG, Respiration and arrhythmia detection performance. GE Healthcare, LLC
Devices TopCare Clifford THE BIG RED DOG power toothbrush for kids! UPC 071031069496, all lots Class II Ranir, LLC is recalling all lots of Up & Up brand Kid's Power Toothbrush and TopCare brand Clifford Kids Power Toothbrush because the tufted disk may become detached from the power brush handle. If the tuft retention disk detaches from the handle, it is a potential choking hazard for children three years old and younger. Ranir Corporation
Devices UP & UP kids' power toothbrush UPC 071031015523, all lots Class II Ranir, LLC is recalling all lots of UP & UP brand Kid's Power Toothbrush and TopCare brand Clifford Kids Power Toothbrush because the tufted disk may become detached from the power brush handle. If the tuft retention disk detaches from the handle, it is a potential choking hazard for children three years old and younger. Ranir Corporation
Devices Video Monitor Suspensions that may be on the following Fluoroscopic and Radiographic X-Ray systems: Precision 500D, Legacy, Prestilix, Monitrol, RFX, SFX, Tilt-C, Prestige VH, Prestige SI, and Prestige SII Product Usage: The systems are intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations on both adult and pediatric subjects. The systmes are used for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. 182, 00000000159728, 719723, 00000000045GP5, 00000000047GP1, 00000000120GP6, 00000000167GP7, 00000000168GP5, 00000000169GP3, 00000000170GP1, 00000000171GP9, 00000000175GP0, 00000000177GP6, 00000000180GP0, 00000000182GP6, 00000000184GP2, 00000000185GP9, 00000000186GP7, 00000000190GP9, 00000000223GQ8, 00000000252GP7, 00000000254GP3, 00000000256GP8, 00000000259GP2, 00000000277GQ4, 00000000331GP9, 00000000334GP3, 00000000353GP3, 00000000379GP8, 00000000380GP6, 00000000381GP4, 00000000382GP2, 00000000438GP2, 00000000439GP0, 00000000440GP8, 00000000444GP0, 00000000490GP3, 00000000491GP1, 00000000506GP6, 00000000556GP1, 00000000558GP7, 00000000590GP0, 00000000591GP8, 00000000592GP6, 00000000593GP4, 00000000594GP2, 00000000669GQ2,, 00000000694GP0, 00000000695GP7, 00000000701GP3,  ...
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Class II GE has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension. During several Preventive Maintenance activities it was discovered that the 4 outer screws that hold the overhead Video Monitor Suspension to the carriage were missing since installation of the system. GE is not aware of any fall of the overhead monitor suspension. GE Healthcare, LLC
Devices PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478 The intended use of the SIEMENS branded, ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. 550 TxT table - part number 07346534. Class II Update to correct the possibility for patients or operators to have their fingers trapped or pinched between the table top and the bottom frame of the 550 TxT Treatment Table. Combined with this update instruction is a second complaint issue related to an incident in which a cable inside of the TxT" Treatment Table has been damaged due to contacting a moving part. The resulting short-circuit caused overheating of an electronic circuit board inside the table base. Siemens Medical Solutions USA, Inc
Devices ADAC ARGUS Gamma Camera Systems & ADAC CIRRUS Gamma Camera Systems. Distributed by Philips Medical Systems, Cleveland, OH ADAC ARGUS: Model #882060; Serial #: 1023, 1178, 106785, 136560, 1100005, 9051005, 9304030, 9309011, 9501007, 9509005, 9510027, 9510028, 9603042, 9603043, 9604044, 9604047, 9605011, 9607060, 9609065, 9610072, 9704081, 9709090, 9710097, 9711103, 9712105, 9712106, 9801107, 9801109, 9802112, 9803001, 9803116, 9804126, 9804129, 9806136, 9807138, 9807422,9810527, 9901156, 9901160, 9901162, 9908167, 9909172, 9910176, 00709B, 0101003A,  ...
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Class II The recalling firm determined that visual inspections of the fork joints behind the detector that are conducted during six month preventive maintenance (PM) may not detect small cracks or deficiencies in the fork weldment. Philips Medical Systems (Cleveland) Inc
Devices Composix L/P with Echo PS 10" X 13" Product Code 0144113 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair. Lot# HUXH0294 Class II Product labeling does not match product configuration. Davol, Inc., Subs. C. R. Bard, Inc.
Devices Composix L/P with Echo PS 6" X 8" Product Code 0144680 The Composix L/P Mesh with Echo PS Positioning System is a non-absorbable sterile lightweight mesh prosthesis, with a preattached removable positioning system. This system is indicated and designed for the reconstruction of soft tissue deficiencies during laproscopic ventral hernia repair. Lot# HUXG0491, HUXH0295 Class II Product labeling does not match product configuration. Davol, Inc., Subs. C. R. Bard, Inc.
Devices SIMVIEW NT and SIMVIEW NT with IDI: October 01, 2012 Siemens ceased Simview distribution. Manufactured by: Mecaserto now known as Mecasim Parc de lEsplanade 9,Rue Niels Bohr 77400 Saint Thibault des Vignes- France The intended use of the SIEMENS branded SIMVIEW NT and SIMVIEW NT with IDI is a radiation therapy simulation system. SIMVIEW NT Part number: 5496992 SIMVIEW NT with IDI Part number: 5497016 US Serial numbers: 6019 6029 6032 6035 6068 6080 6001 International serial numbers: 6060 6027 6067 1236 3654 4190 6006 6007 6014 6015 6020 6022 6023 6024 6030 6042 6048 6049 6053 6054 6062 6065 6069 6070 6084 6085 6088 6092 6095 6098 6099 6103 6104 6041DEL 6099-1 1256 6017 6028 6034 6036 6041 6044 6047 6050 6052 6055 6056 6058 6066 6072 6073 6079 6082 6083 6089 6090 6093 6105. Class II In a very rare occurrence an intended movement of the SimView NT simulation system components could not be stopped with usual hand control or the collision detection functionality. Siemens Medical Solutions USA, Inc
Devices Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer medical gases to a patient during anesthesia. The CPAP Circuit is intended to increase the airway pressure of a patient. PartNumber : 4S78XX00,155512,155518,156505,156545,1576162,1576214,542011,542021,542031,1553196,1572347,1553402,156205,156310,1574701,1574710,1574711,1574712,1574723,1572414,A4JXXXXX,6463,C311123X,C6X1XX1X,207002,C316123X,1560023,201814,1730327,20CF800C,C116123X,1570103,20CT8050,1577112,1552016,A4JXOXXX,CXX61X2X,1552017,1552018,20CT8048,20CT8055,M1171508,M1181639,1552020,M1162025,155200EU,1552017CN,1574792,M1171508VS,M1181639VS,1552026,1552027,1552028, Class II Vital Signs Devices (VSD), a GE Healthcare Company, has become aware through a customer complaint of a safety issue associated with a certain Breathing Circuit. A circuit in use was occluded by a blue port cap that was inadvertently attached to the circuit as a result of an internal inspection error and will cause occlusion of gas flow. Vital Signs Colorado Inc.
Devices Computed Tomography X-Ray System (Brilliance CT Big Bore Oncology & Brilliance CT Big Bore Radiology) Distributed by Philips Healthcare System, Cleveland, OH. Produces cross-sectional body images by computer reconstruction of x-ray transmission data taken at different angles and planes. Model #: 728243; 7133, 7170, 7225, 7262, 7265, 7701, 7706, 7779, 7788, 7792, 7797, 7802, 7805, 7806, 7807, 7808, 7810, 7811, 7812, 7814, 7815, 7816, 7824, 7831, 7832, 7833, 7834 ,7835. Model #728244; 7621, 7636, 7809 & 7844. Class II Machine Name in TumorLOC Basic Mode is obscured. When TumorLOC is in Basic Mode and Set Vertical Laser equals Yes, the Machine Name label and field are covered by the controls above it. The Machine Name cannot be viewed or changed. Philips Medical Systems (Cleveland) Inc
Devices Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utilized on all upright ZEISS microscopes (Axio Imager, Axio Scope. A1, Axio Lab. A1). Component used to determine composition of urinary calculi, urinary sediments, bio-crystallates and diagnosis of pathological characteristics in medical applications (e.g.: testing for gout or pseudogout); also used for non-medical scientific research. part number 473704-0000-000 Class II Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on Standard Pathology Microscopes due to misalignment of the lambda plate. Zeiss, Carl Inc
Devices Pulmonary Hemi-Artery SG Used in heart surgery Serial No. 10119759, Model SGPH00 Class II Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death. CryoLife, Inc.
Food Candy Place Chocolate Santas, in 11 oz clear plastic bags, individually wrapped assortment of double chocolate, caramel, and peanut butter flavored chocolates, distributed by Giant Eagle, Pittsburgh, PA. Ingredients: Sugar, partially hydrogenated vegetable oil (Palm kernel, coconut, and/or palm), cocoa (processed with alkali) whey, lactose, skim milk, soy lecithin (emulsifier), vanillin (artificial flavor). UPC 3003407341, Sell date: 6/24/14 Lot #: 309 (a four digit time code that changes) 27 Class I Giant Eagle Candy Place Chocolate Santas do not declare the peanut allergen ingredient on the primary package label. Also, the caramel variety ingredient statement was not included in the finished product label. Giant Eagle
Devices AMS-530 7 Microbore Trifurcated Extension sets Product Usage: Intravascular administration set. Lot Number: 1306034, 1307011 Class II Defective component may cause extension sets to leak. Churchill Medical Systems, Inc.
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