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U.S. Department of Health and Human Services

Enforcement Report - Week of October 9, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue. Lot number 226201 Class II Firm became aware that some products within the specified lot may not have been sealed appropriately, thus compromising the sterile barrier. PhotoMedex, Inc.
Devices Solitaire-35 Peek Solitaire Anterior Spinal System. The Solitaire-35 is an intervertebral body fusion device. 14-535140 12 mm 6-deg narrow 2327561 October-22 2302271 April-22 14-535141 14  ...
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Class II Several complaints were recorded regarding one of the three screws driving through the cage of the Solitaire 35 implant. Ebi, Llc
Food Benefiber Fiber Supplement, Orange Natural Flavor, Non-Thickening Powder, Sugar Free, packaged in 5.7-oz. (35 servings) bottles, UPC 300670068356, 9.4-oz (58 servings) bottles, UPC 300670068585, and 18.7-oz. (115 servings) bottles, UPC 300670068158. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, Made in France. 5.7-oz. (35 servings) bottles: 10100230; 9.4-oz. (58 servings) bottles: 10119358, 10121489, 10121490, 24596401, 24596402, 24680101, and 24767601; and 18.7-oz. (115 servings) bottles: 24596701. Class II The products are being recalled due to the receipt of a relatively high number of consumer complaints. Novartis Consumer Health
Food Benefiber Plus Heart Health Non-Thickening Powder, Sugar Free, packaged in 6.4-oz (48 servings) bottles, UPC 300673002487. Distributed by: Novartis Consumer health, Inc., Parsippany, NJ 07054-0622. Made in France. 10118915, 10118916, 10118917, 10118918, 10120338, 10120361, 10122590, 10122591, 10123950, 10126662, and 10127376 Class II The products are being recalled due to the receipt of a relatively high number of consumer complaints. Novartis Consumer Health
Food Benefiber Fiber Drink Mix, Cherry Pomegranate, Sugar Free, packaged in 5.0-oz. boxes containing 24/0.21-oz. stick packs, UPC 300670107246. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Made in France. 10116609, 10118436, 10121279, 10121280, 10122653, 10122654, 10125466, and 10128711 Class II The products are being recalled due to the receipt of a relatively high number of consumer complaints. Novartis Consumer Health
Food Benefiber Fiber Drink Mix, Kiwi Strawberry, Sugar Free, packaged in 5.0-oz. boxes containing 24/0.21-oz. stick packs, UPC 300670106249. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Made in France. 10114419, 10115003, 10118673, 10121091, 10121092, 10121093, 10121094, 10123826, 10125460, and 10125461 Class II The products are being recalled due to the receipt of a relatively high number of consumer complaints. Novartis Consumer Health
Food Benefiber Fiber Supplement Plus Calcium, Orange Natural Flavor, Sugar Free, packaged in 10.76-oz (48 Servings) bottles, UPC 300670108489. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Made in France. 10102129, 10102130, 10102131, 10104656, 10104657, 10104658, 10104659, 10107484, 10114954, 10124211, and 10125514 Class II The products are being recalled due to the receipt of a relatively high number of consumer complaints. Novartis Consumer Health
Food Benefiber Non-Thickening Powder, Sugar Free, packaged in the following configurations: (1) 2.8-oz. (20 servings) bottles, UPC 300670044206; (2) 4.6-oz. (32 servings) bottles, UPC 300670044329; (3) 5.4-oz. (38 servings) bottles, UPC 300670044381; (4) 8.6-oz. (62 servings) bottles, UPC 300670044626; (5) 12.3-oz. (90 servings) bottles, UPC 300670044909; (6) 16.7-oz. (125 servings) bottles, UPC 300670044831; (7) 1.6-lb. (190 servings) bottles, UPC 300670044190; (8) 20.2-oz .(125+25=150 servings) bottles, UPC 300670174590; (9) 10.3-oz. (62+13=75 servings) bottles, UPC 300670175757; (10) Bulk .12-oz. (1 serving) stick pack, UPC 300679999996; (11) 3.45-oz. boxes containing 28/0.12-oz. stick packs, UPC 300670030285; and (12) 4.19-oz. boxes containing 28+6/0.12-oz. stick packs, UPC 300670030346. Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622. Made in France. 2.8-oz. (20 servings) bottles: 10081233, 10084981, 10086954, 10087654, 10089097, 10090985, 10095687, 10095688, 10102413, 10102758, 10106405, 10107215, 10110117, 0112155, 10115504, 10119610, 10120346, 10123373, and 10124210; 4.6-oz. (32 servings) bottles: 10093120, 10099454, 10101273, 10102759, 10104643, 10107322, 10107334, 10109690, 10114152, and 10123951; 5.4-oz. (38 servings) bottles: 10079944, 10079945, 10084982, 10086957, 10087655, 10088811, 10089098, 10089099, 10090986,  ...
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Class II The products are being recalled due to the receipt of a relatively high number of consumer complaints. Novartis Consumer Health
Devices Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. Class II Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Atrium Medical Corporation
Devices Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. Class II Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Atrium Medical Corporation
Devices Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. Class II Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Atrium Medical Corporation
Devices Flixene IFG with Assisted Delivery Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. Class II Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Atrium Medical Corporation
Devices Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. Class II Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Atrium Medical Corporation
Devices Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. Class II Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Atrium Medical Corporation
Devices Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. Class II Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Atrium Medical Corporation
Devices Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. Class II Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Atrium Medical Corporation
Devices Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. Class II Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Atrium Medical Corporation
Devices Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. Class II Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Atrium Medical Corporation
Devices Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. Class II Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Atrium Medical Corporation
Devices Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. Class II Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Atrium Medical Corporation
Devices Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. Class II Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Atrium Medical Corporation
Devices Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access. Product manufactured between April 3, 2012 and May 14, 2013 and can be identified by their expiration date; between April 2017 and May 2018. Class II Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto the sterile field Atrium Medical Corporation
Devices MedStream Programmable Pump; 20ml - 91-4200US Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. Lot/Serial Number US: NMBJ7K, NMBJ5C Class I Drug flow rates exceeding programmed flow rates. Codman & Shurtleff, Inc.
Devices MedStream Programmable Pump; 40ml - 91-4201US Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. Lot/Serial Number US: NMBKB6, NMBKFF, NMBKC5, NMBKCF, NMBJ3K Class I Drug flow rates exceeding programmed flow rates. Codman & Shurtleff, Inc.
Devices MedStream Refill Kit, U.S: 91-4287 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. Lot/Serial Number US: 13B090CT Class I Drug flow rates exceeding programmed flow rates. Codman & Shurtleff, Inc.
Devices MedStream Refill Kit (1 unit), EMEA: 91-4289 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. OUS: Per recall strategy Class I Drug flow rates exceeding programmed flow rates. Codman & Shurtleff, Inc.
Devices MedStream Refill Kit (6 units), EMEA: 91-4290 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. OUS: Per recall strategy Class I Drug flow rates exceeding programmed flow rates. Codman & Shurtleff, Inc.
Devices MedStream Refill Kit, U.S (6 units): 91-4288 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. N/A Class I Drug flow rates exceeding programmed flow rates. Codman & Shurtleff, Inc.
Devices MedStream Programmable Pump; 40ml Pump EMEA 91-4201 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. OUS: Per recall strategy Class I Drug flow rates exceeding programmed flow rates. Codman & Shurtleff, Inc.
Devices MedStream Programmable Pump; 20ml Pump EMEA 91-4200 Product Usage: The Medstream programmable pump is intended for the intrathecal delivery of Baclofen in the US market and for the intrathecal delivery of Morphine or Baclofen in the EMEA market. Refill Kits- are intended for use in the filling and re-filling of the Medstream pump reservoir. OUS: Per recall strategy Class I Drug flow rates exceeding programmed flow rates. Codman & Shurtleff, Inc.
Veterinary Apomorphine HCL 3 MG/ML INJECTABLE Sterile Rx Only Lot # 03142013@7 Date Made 3/14/2013 Class II Lack of sterility assurance of sterile injectables. Beacon Hill Medical Pharmacy, P.C.
Veterinary Buprenorphine .3 MG/ML INJECTABLE Buprenorphine .5 MG/ML INJECTABLE Sterile Rx Only Lot #"s: 01222013@4 (Date Made 1/22/2013), 02222013@2(Date Made 2/22/2013) , 03142013@3 (Date Made 3/14/2013), 04182013@12 (Date Made 4/18/2013), 05062013@15 (Date Made 5/6/2013) , 07082013@25 (Date Made 7/8/2013) , 01022013@12 ( Date Made 1/2/2013), 04022013@25 ( Date Made 4/2/2013), 07082013@23 (Date Made 7/8/2013) Class II Lack of sterility assurance of sterile injectables. Beacon Hill Medical Pharmacy, P.C.
Veterinary Cyclosporine (A) 2% (PF) Aqueous Susp Sterile Rx Only Lot #": 06032013@6 (Date Made 6/3/2013) Class II Lack of sterility assurance of sterile injectables. Beacon Hill Medical Pharmacy, P.C.
Veterinary Diazepam 5MG/ML INJECTABLE Sterile Rx Only Lot #'s: 01212013@13 (Date Made 1/21/2013) 05302013@8 (Date Made 5/30/2013) Class II Lack of sterility assurance of sterile injectables. Beacon Hill Medical Pharmacy, P.C.
Veterinary Meloxicam 10 MG/ML INJECTABLE Sterile Rx Only Lot #'s: 07112013@10 (Date Made 7/11/2013) 01172013@5 (Date Made 1/17/2013) 03012013@20 (Date Made 3/1/2013) 03142013@8 (Date Made 3/14/2013) Class II Lack of sterility assurance of sterile injectables. Beacon Hill Medical Pharmacy, P.C.
Veterinary Tacrolimus Solution 0.02% OPTHALMIC Sterile Rx Only Lot #'s: 03192013@34 (Date Made 3/19/2013) 01282013@19 (Date Made 1/28/2013) Class II Lack of sterility assurance of sterile injectables. Beacon Hill Medical Pharmacy, P.C.
Drugs Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE 19720, List No. 152, NDC 10135-152-01, UPC 3 10135 15201 8. Lot #: 3213, Exp 12/13 Class II CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices as noted by a recent inspection of the manufacturing firm. Marlex Pharmaceuticals, Inc.
Devices Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system. Catalog Lots ---------------------------------- 67200000 15918614 67200200 15892736 67200400 15892737, 15897416 67200500 15901314 67203400 15922021 67203600 15897418 67204000 15925687 67205200 15892738, 15892739 67205400 15885645, 15887472, 15897420 67205600 15901319 67206000 15897422 67207200 15892740 67208000 15892741 67208200 15887473, 15887474, 15897424 67208300 15901321 67212600 15916942 67213000 15916943 67227000 15901323 Class II Due to a labeling error related to the conversion of the inner diameter of the catheter from inches to millimeters. The English dimension is correct and is the primary dimension. Cordis Corporation
Devices Lactate Membrane units for E7077 Electrode Radiometer Medical ApS. The intended use is in vitro testing of samples of whole blood. Part Number: 942-066 R1741 to R1869 Class II RADIOMETER became aware that some membranes may have enzyme residue on the outer membrane. The enzyme residue may cause an initial negative bias on the reported Lactate result upon replacement of the Lactate membrane. Radiometer America Inc
Devices H&H Emergency Cricothyrotomy Kit (Part No. HHECT01/ HHECTK01, NSN 6515-01-573-0692), vacuum sealed and packaged in a 5 mil poly bags, labeled in part ***H & H Associates, Inc. CAGE 1NNH6 www.gohandh.com Ordinary, VA 23131 (800) 326-5708***. The product is used to maintain fracture alignment. Lots\EXP Dates: CKBD033, CKBE033 August 2015 CKBD034, CKBF034, CKBG034 August 2015 CKBP045 November 2015 CKBP047, CKBQ047 November 2015 CKBR060 February 2016 CKBT065 April 2016 CKBV070, CKBW070, CKBX070 May 2016 CKBX071 May 2016 CKBX076 June 2016 CKBX078 July 2016 CKBX079, CKBY079 July 2016 CKBY080, CKBZ080, CKCA080 July 2016. Class I Medical device tubing used for endotracheal airway application may become weakened and rendered ineffective. H & H Associates
Food Tullys® House Blend Coffee 12-ct K-Cup® packs; Product Code: 8802 (Case of 6 - 12 count retail boxes) UPC: 10099555088028 Best By: 27 MAR 2014, 28 MAR 2014 Lot Numbers: NA 8802 PL055 3181, NA 8802 PL055 3182 Class III Individual regular (caffeinated) K-Cup packs were packaged inside multiunit Decaffeinated retail boxes. Green Mountain Coffee Roasters
Food Tully's House Blend Decaffeinated K-Cup® Packs (12-ct retail box) Product Code: 8803; UPC: 099555088038 Best By: 27 MAR 2014, 28 MAR 2014 Lot Numbers: NA PL055 3181, NA PL055 3182 Class III Individual regular (caffeinated) K-Cup packs were packaged inside multiunit Decaffeinated retail boxes. Green Mountain Coffee Roasters
Devices Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece. Part Number DF4110-61 Lot Number I063N Class I King Systems received a customer complaint indicating that the customer had ordered a breathing circuit with a Latex breathing bag. The product they received contained a Latex breathing bag, but was labeled as non-latex. King Systems Corp.
Devices King LTS-D Oropharyngeal Airways Product Usage: The King LTS-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents. Part Number(s): KLTSD415 Lot Number(s): IV1V3 Class II On December 13, 2012, King Systems initiated a voluntary recall of one (1) case(s) (5) individual products) from one (1) lot [(IV1V3) 62 cases, 310 products]of King LTSD Oropharyngeal Airways because the package label indicated that the airway was a size 5 when in fact the airway in the package was a size 4. When King manufacturers a lot, all of the components are the same size, part number etc. In this instance, the lot number IV1V3 was for size 5 King LTSD airways, part number KLTSD415. The manufacturing and inventory records show that one case (5 products) of KLTSD size 4 airways were erroneously manufactured as part of lot IV1V3. King Systems has not received any further complaints. King Systems Corp.
Devices Selenia Full Field Digital Mammography System with software versions 5.0.x and 5.1.x The Selenia Full Field Digital Mammography system generates digital mammography images that can be used for screening and diagnosis of breast cancer. The Selenia Full Field Digital Mammography System is intended for use in the same clinical applications as traditional screen-film mammography systems. Mammography images can be interpreted on either hard copy film or soft copy review workstations, cleared for mammography Software versions 5.0.x and 5.1.x Class II Software: When the Selenia upon meeting the hard drive threshold of 4,000 images, may delete the most recently dated images Hologic, Inc.
Drugs 5% Lidocaine HCl and 7.5% Dextrose Injection, USP, 2 mL Single Dose Ampuls, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4712-01 Lot 23-227-DK Class II Presence of Particulate Matter; report of glass particles in the ampule after dilution Hospira Inc.
Devices Product Name: AVEA® Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device. All Models. Serial Numbers: BCV01807 AEV01754 AFV01269 AFV01692 AFV01694 AFV02330 AFV02338 AFV02339 AFV02349 AFV02350 AFV02515 AGV01817 AGV01818 AGV02135 AGV02189 AGV02296 AGV02306 AGV02344 AHV03372 AJV01001 AJV01242 AJV01292 AJV01297 AJV01300 AJV01301 AJV01701 AJV01702 AJV01703 AJV01716 AJV01718 AJV01732 AJV01733 AJV01746 AJV01748 AJV01749 AJV01819 AJV01820 AJV01824 AJV02086 AJV02088 AJV02089 AJV02090 AJV02091 AJV02093 AJV02097 AJV02099  ...
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Class I CareFusion has identified a potential risk associated with AVEA® ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. CareFusion is voluntarily initiating a field correction of the affected devices to correct the error. Carefusion 211 Inc dba Carefusion
Drugs Venlafaxine (Venlafaxine Hydrochloride) extended release Tablets, 225 mg, packaged in a) 30- count bottle (NDC 0131-3268-32) and b) 90-count bottle (NDC: 0131-3268-46), Rx only, Manufactured by: Kremers Urban Pharmaceuticals Inc. For: Osmotica Pharmaceutical Corp., Wilmington, NC 28405, USA. Lot #: a) 58975, 58976, 58977, 65165 , Exp 01/14; b) 58973, 58974, 65131, Exp: 01/14 Class III Failed Dissolution Specification; 12 hour time point at 18 months shelf life Osmotica Pharmaceutical Corp
Drugs Estradiol 1.25 mg, Progesterone 25 mg/mL injectable, 20 mL sterile vials, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135. Lot 05022013@20, Exp 10/29/13 Class II Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory. Apothecary Shoppe
Drugs SIH-Testosterone Cypionate 200 mg/mL Injectable, 10 mL sterile vial, The Apothecary Shoppe, 6136 E. 51st St. Tulsa, OK 74135. Lot #s: 05132013@25, Exp 11/9/13; 08072013@4, Exp 2/3/14 Class II Lack of Assurance of Sterility: concerns of sterility assurance with the pharmacy's independent testing laboratory. Apothecary Shoppe
Devices GE Healthcare, Discovery MR750 3.0T, Optima MR450w 1.5T, and Discovery MR450 1.5T . scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Signa® MR 750 System is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and organs of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. The images produced by the GE Signa® MR 750 System reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images when interpreted by a trained physician yield information that may assist in diagnosis. The indications for use for the 3.0T GE Signa® MR750 System are similar to those for the Signa® HDx Magnetic Resonance System and the Siemens MAGNETOM Verio MR System. K113490: The Optima" MR450w is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being images, contrast agents may be used. The images produced by the Optima" MR 450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. K083147: The Discovery MR 450 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images spectroscopic images parametric maps, and/or spectra, dynamic images of the structures and/or functions of the entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by the Discovery MR450 reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis. Mfg Lot or Serial # 00000029854MR5 00000288907MR9 00000289309MR7 00000289310MR5 00000289961MR5 00000290050MR4 00000290137MR9 00000290202MR1 00000290457MR1 00000290502MR4 00000290659MR2 00000290773MR1 00000290957MR0 00000291185MR7 00000291325MR9 00000291363MR0 00000291397MR8 00000291464MR6 00000291489MR3 00000292367MR0 00000292471MR0 00000292528MR7 00000292634MR3 00000292843MR0 00000293065MR9 00000293874MR4 00000294098MR9 00000294398MR3 00000294472MR6 00000294556MR6 00000294576MR4 00000294718MR2 00000295111MR9 00000295134MR1 00000295215MR8 00000296070MR6 00000296097MR9 00000296171MR2 00000296226MR0 00000296228MR0 00000296300MR7 00000296369MR2 00000296429MR4 00000296462MR5 00000296469MR0  ...
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Class II GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of Discovery MR450, Discovery MR750, and Optima MR450w products. The yellow foam strip used between the end bell covers and patient bore of certain GE MR Products may extend past the surface of the covers. The foam itself is not hazardous. However, any fluid or body substance absorbed by the extended foam may come into contact with patients and act as a fomite potentially transferring infectious agents from one patient to another. GE Healthcare, LLC
Drugs Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only, Manufactured by: Watson Laboratories, Inc. Corona, CA 92880 USA, NDC 0591-0825-01 Lot #: 705791A, Exp 04/2015 Class II Presence of Foreign Tablets/Capsules: 20 tablets of Oxycodone/APAP 7.5/500 mg were found in a sealed 100 count bottle of Oxycodone and Acetaminophen Tablets, USP 10/650 mg lot# 705791A. Watson Laboratories Inc
Drugs Sodium Phosphate Injectable, 150mM/50mL Phosphorus 200mEq/50mL Sodium, 50 mL Single Dose Vial, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518. Lot #814748-LG14917, Exp 10/31/13 Class II Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. Triangle Compounding
Drugs Histamine, 10 ng/mL Injectable, MDV, Rx only, Triangle Compounding Pharmacy, 3700 Regency Parkway, Suite 140, Cary NC 27518. Lot 74651-LG4973, Exp 12/4/13 Class II Lack of Assurance of Sterility:The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured. Triangle Compounding
Devices McKesson Horizon Medical Imaging (HMI) Radiological Image Processing System, product versions 4.6.1 to 11.6., is a medical image and information management application intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from medical imaging systems. Products: HMI 4.6.1; HMI 5.x (5.0.1, 5.0.5, 5.0.6, 5.0.7, 5.0.8); HMI 11.0x (11.0.5, 11.0.6, 11.0.6 FR EP2, 11.0.7, 11.0.8); HMI 11.5x (11.5, 11.5.1, 11.5.2) and HMI 11.6. Class II Software malfunction may occur resulting in a certain combination of server configurations which has the potential to cause image loss. Mckesson Information Solutions LLC
Drugs Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4495-22 Lot #s: 7800932, 7800933, exp 02/15 Class II Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers. AmeriSource Bergen
Drugs Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4496-22 Lot #s: 7800929, 7800931, Exp 02/15; 7800962, Exp 03/15 Class II Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers. AmeriSource Bergen
Devices NC Sprinter; Rapid Exchange Balloon Dilatation Catheter; Sterile; 2.25 mm; Model NCSP22512X. Manufacturer: Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432 The NC Sprinter Rapid Exchange Balloon Dilatation Catheter is a Percutaneous Transluminal Coronary Angioplasty (PTCA) Rapid Exchange System. The balloon at the distal end of the catheter can be inflated to a defined diameter at a specific pressure (see labelling). The proximal end of the catheter has a female luer for attachment to an inflation device. The catheter provides a lumen which enables the use of a guide wire to position the catheter. Radiopaque balloon marker(s) enable accurate placement. Shaft markers for brachial and femoral techniques are in place. Lot number 207002011; Exp 5-13-2015. Class II Compliance chart included in lot 207002011 of the NC Sprinter RX 2.25 x 12 mm products lists the size of the device as 2.5mm instead of the correct 2.25mm size. Medtronic Vascular, Inc.
Devices DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Container, Unassembled, 800 ML DISP Container w/6' patient tubing, and 800 ML DISP Container w/6' patient tubing, assembled. DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter) is used to remove fluids from the airway or respiratory support system and infectious materials from wounds. It is available for use by consumers by physician order. Part Number 7305D-634 with model numbers 7305D-632, 7305D-633, and 7305D-633-25 Class II End users of the DeVilbiss Disposable Suction Container/Filter had exposed the bacterial filter cartridge to fluid, thereby occluding the filter and rendering it unusable. DeVilbiss Healthcare LLC
Devices SHOPKO Waterproof Adhesive Pads Antibacterial. Used for covering minor cuts, scrapes and burns. UPC Code #: 400129133311 Lot numbers: 330543 and 341383 Class II No antibacterial bandages were packed in boxes labeled as antibacterial. ASO, LLC
Devices Ultima OPCAB System, Sterile, Rx Only, Product Usage: Intended for use during performance of minimally invasive cardiac surgery through a sternotomy incision approach. The ULTIMA Access RailPlatform in combination with the Activator II Drive Mechanism is used to spread the sternum, providing access and direct visualization to the thoracic cavity. The AccessRail Platform also allows for the organization of pericardial sutures. The ULTIMA Stablizer isolates and provides local immobilization of the target vessel on the beating heart. ULTIMA OPCAB System Part Nos. OM-2003S (LOT #25052176) and OM-2001D (LOT #25052200). Class II MAQUET has identified a potential issue with the ULTIMA OPCAB (part numbers OM-2003S & OM-2001D). Labeling for the 2 blade lots had been incorrectly applied. The standard blades from Lot #25052176 were incorrectly labeled as deep blades, and the 20 deep blades from Lot #25052200 were incorrectly labeled as standard blades. Maquet Cardiovascular, LLC
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