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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 103642540 (2 units) Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Blood Systems, Inc.
Biologics Platelets Pheresis Leukocytes Reduced 103402373 Class II Blood product, which was not tested for pH and platelet count, was distributed. Blood Systems, Inc.
Biologics Source Plasma 3380000447, 3380000466, 3380000462, 3380000465, 3380000461, 3380000464, 3380000463, 3380000448, 3380000454, 3380000455, 3380000458, 3380000460, 3380000450, 3380000451, 3380000452, 3380000453, 3380000467, 3380000449, 3380000456, 3380000459 Class II Blood products, for which the sample tubes for NAT testing may have been stored at an unacceptable temperature, were distributed. Talecris Plasma Resources, Inc.
Biologics Red Blood Cells Leukocytes Reduced 022FS93673, 022FG83722, 022FL08670, 022FL08692, 022FL08701, 022FP17540, 022FQ86931, 022FQ86938, 022FQ86945, 022FZ83162, 022FZ83166, 022FZ83172, 022FZ83176, 022FZ83287, 022FZ83304, 022FZ83339, 022FZ83371, 022FZ83377, 022FZ83391, 022FZ83400, 022FZ83454, 022GJ26949, 022GT40909, 022GT40921, 022GT40927, 022GT40941, 022GT40945, 022KE80962, 022KE80970, 022KE80979, 022KE80982, 022KE80988, 022LC74593, 022LC74598, 022LC74603, 022LC74768, 022LC74781, 022LC74785, 022LC74821, 022FL08688, 022KE81220, 022LC74822, 022LC74824, 022LZ49041, 022GK39785, 022FN15363, 022FN15365, 022FN15382, 022GQ51845, 022GQ51649,  ...
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Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma 022FG83722, 022FL08071, 022FL08086, 022FL08670, 022FL08701, 022FN15377, 022FP17540, 022FQ88491, 022FS93695, 022FZ82230, 022FZ82479, 022FZ82635, 022FZ82730, 022FZ82734, 022FZ82878, 022FZ82910, 022FZ82992, 022FZ83162, 022FZ83294, 022FZ83304, 022FZ83339, 022FZ83454, 022GK38673, 022GM65828, 022GP36534, 022GP36541, 022GQ51845, 022GQ51847, 022GQ51850, 022GT40921, 022GT40941, 022GT40945, 022GY40823, 022KE80672, 022KE80707, 022KE80962, 022KE80979, 022KH53831, 022KL79196, 022KL79258, 022LC73637, 022LC73696, 022LC74821, 022LZ49038, 022LZ49041, 022LZ49044, 022FZ82885, 022KE81215, 022LC74822, 022LC74824 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Biologics Plasma Frozen within 24 hours (FP24) 022GQ51643, 022FL08688, 022FN15361, 022FN15424, 022FN15428, 022FN15432, 022FN15436, 022FQ86501, 022FQ86528, 022FQ86541, 022FQ88408, 022FQ88437, 022FS93673, 022FZ82472, 022FZ82606, 022FZ82953, 022FZ83360, 022GK38531, 022GK39776, 022GK39785, 022GP36563, 022GQ51649, 022GT40463, 022GV41774, 022GY40839, 022KE80677, 022KE80683, 022KH53827, 022LC74593, 022LC74598, 022LC74603, 022LC74781 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 022GJ24195 (2 units) Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Biologics Red Blood Cells 022FN15375, 022FS93687 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Biologics Platelets Leukocytes Reduced 022GL83277 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced Irradiated 022FN15436, 022FZ83294, 022FZ83380, 022FZ83466, 022LC74607 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American National Red Cross (The)
Biologics Source Plasma 3440027170, 3440026953, 3440026567, 3440026309, 3440026110, 3440025821, 3440025612, 3440025322, 3440025128, 3440024872, 3440024697, 3440024460, 3440024272, 3440024007, 3440023735, 3440023460, 3440023271, 3440023025, 3440022849, 3440022512, 3440022367, 3440022259, 3440021975, 3440020798, 3440020621, 3440020435, 3440020184, 3440019945, 3440019807, 3440019560, 3440019436, 3440019076, 3440018876, 3440018612, 3440018397, 3440018139, 3440017939, 3440017715, 3440017537, 3440017337, 3440017136, 3440016957, 3440016804, 3440016284, 3440016065, 3440015801, 3440015606, 3440015369, 3440015230, 3440014751,  ...
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Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Talecris Plasma Resources, Inc.
Drugs Esbelin Siloutte Mezcal Herbal con L-Carnitine Suplemento Alimenticio, 30 capsule bottle, Hecho En Mexico Por: Soluciones HGC S. de R.L. de C.V. Av. Independicia #1016 Frac. La Rinconada Aguascalientes, Ags. Mex C.P. 20136, UPC 7502011000060 All lots Class I Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs. Herbal Give Care Llc
Drugs Esbelin Siloutte Te, Suplemento Alimenticio, herbal tea in a gold foil/plastic zip-lock pouch. Hecho en Mexico Por: Herbal Give Care, Av Independencia # 1016, Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7562684652553 All lots Class I Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs. Herbal Give Care Llc
Drugs Esbelder Siloutte Suplemento Alimenticio, 30 capsule bottle, Hecho en Mexico Por: Herbal Give Care, Av Independencia # 1016, Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000268 All lots Class I Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs. Herbal Give Care Llc
Drugs Esbelder Man Herbal Blend With L-Carnitine Dietary Supplement, 30 capsule bottle, Made in Mexico: Soluciones S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000275 All lots Class I Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs. Herbal Give Care Llc
Drugs Esbelder Fem Mezcla con L-Carnitina Suplemento Alimenticio,30 capsule bottle, Hecho en Mexico: Soluciones HGC S. de R.L. de C.V. Av. Independencia #1060 Fracc. La Rinconada, Aguascalientes, Ags. Mex. C.P. 20136. UPC 7502011000251 All lots Class I Marketed Without an Approved NDA/ANDA: Products found to contain undeclared sibutramine, N-Desmethylsibutramine, and N-di- Desmethylsibutramine. Sibutramine was removed from the U.S. market for safety reasons, making these products unapproved new drugs. Herbal Give Care Llc
Drugs P-BOOST Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466 Lot # F51Q. EXP: 07/16 The UPC Codes for P-Boost are: 1ct - 862545101013 5ct - 862545101051 10ct - 862545101105 20ct - 862545101204 40ct - 862545101402 Class I Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs. Tendex
Drugs NATURECT Capsules Dietary Supplement 500 mg, supplied in 1 count blister pack and 5, 10, 20, and 40- count bottles, Distributed by P-Boost, Los Angeles, CA 900466 Lot # F51Q. EXP: 07/16 The UPC Codes for Naturect are: 1ct- 893020242013 5ct - 893020242051 10ct - 893020242105 20ct - 893020242204 40ct - 893020242402 Class I Marketed Without an Approved NDA/ANDA: FDA analysis found the product to contain undeclared active ingredient, tadalafil, thus making these products unapproved drugs. Tendex
Drugs XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL. Lot # 130710GL, Exp. 07/31/2018 Class I Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. Schindele Enterprises dba Midwest Wholesale
Drugs BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also packaged in 3 pill bottles and 1 pill packs. BoostUtra.com, Springfield, MO. 12 pill bottle and 3 pill bottle: Lot # B70130 Exp. 03/15; 1 pill pack: Lot # 06012011 Exp 06/14. Class I Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. Schindele Enterprises dba Midwest Wholesale
Drugs SEXY MONKEY, 2000 mg, 1 count blister, Distributed by A Herbal Bio, Inc., Bayside, NY. NO LOT NUMBER, Exp 12/31/14 Class I Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. Schindele Enterprises dba Midwest Wholesale
Drugs MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life Distributors, COK Inc., Los Angeles, CA. 1 pill blister packs: Lot OAWF 1027 Exp 1/31/2015 and Lot OAWF1003 Exp 01/31/2015. Class I Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. Schindele Enterprises dba Midwest Wholesale
Drugs Magic For Men, packaged in 1ct blister pack and 12-pill/bottle, 390 mg Manufactured For: BTQ Ski, Inc., Chicago, IL 60638 12-ct.bottle, Lot GP808, Exp. 10/16, 1-ct. blister Lot BN030613, EXP 020615 Class I Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. Schindele Enterprises dba Midwest Wholesale
Drugs ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc., Pasadena, CA. Lot 0512058, Exp. 05/16 Class I Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. Schindele Enterprises dba Midwest Wholesale
Drugs XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA. Lot 130520PL Exp. 05/31/2017 Class I Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil. Schindele Enterprises dba Midwest Wholesale
Drugs PRO ArthMax Dietary Supplement tablets, 750 mg, 120 count bottles, Distributed by Human Science Foundation, Los Angeles, CA Lot# 220113; Exp. 01/16 Lot# 800213; Exp. 03/16 Lot# U133000; Exp. 04/16 Lot# U143200; Exp. 08/16 Lot# YJK015311; Exp. 10/16 Class I Marketed without an Approved NDA/ANDA; FDA analysis found the product to contain Chlorzoxazone, Nefopam, Diclofenac, Ibuprofen, Naproxen, and Indomethacin HUMAN SCIENCE FOUNDATION
Drugs Acetylcysteine Solution, USP, 10%, 30 mL vial, Rx only, Ben Venue Laboratories, Inc., Bedford, OH, NDC 0054-3025-02 2005479, Exp 03/14 Class I Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution Ben Venue Laboratories Inc
Devices GE Healthcare, NeuroMuscular Transmission Module, E-NMT-01 Product Usage: The Datex-Ohmeda S/5TM E-NMT module is indicated for monitoring the relaxation of the patient and regional block stimulation for nerve location. The device is indicated for use by qualified medical personnel only. Mfg Lot or Serial # SJC13245126HA SJC13519186HA SJC13519394HA SJC14041559HA SJC13213573HA SJC13213578HA SJC13213797HA SJC13223964HA SJC13265581HA SJC13265706HA SJC13275798HA SJC13213782HA SJC13223961HA SJC13223967HA SJC13223968HA SJC13234211HA SJC13234212HA SJC13234219HA SJC13234220HA SJC13286412HA SJC13338471HA SJC13338472HA SJC13338473HA SJC13348496HA SJC13348502HA SJC13348506HA SJC13348507HA SJC13348511HA SJC13348512HA SJC13348829HA SJC13369137HA SJC13369138HA SJC13369142HA SJC13369143HA SJC13369145HA SJC13369146HA SJC13369147HA SJC13369148HA SJC13369149HA SJC13369150HA SJC13369151HA SJC13369152HA SJC13369153HA SJC13369154HA SJC13369155HA  ...
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Class II When the E-NMT-01 module is used in conjunction with the ElectroSensor, the Neuromuscular Transmission (NMT) values may indicate a deeper level of muscle relaxation than the actual level of muscle relaxation. In the clinical situation visual movements of the hand are seen after TOF (Train of Four) stimulation, but the patient monitor shows no counts, or counts are not corresponding to the actual amount of movements. This issue may lead to an inadequate dose of muscle relaxants. This issue may occur when the E-NMT-01 module is plugged into the CARESCAPE or the Datex-Ohmeda S/5 Anesthesia monitor. GE Healthcare, LLC
Drugs Effexor XR (venlafaxine HCl) Extended-Release Capsules, 150 mg, packaged in a) 30-count Unit of Use bottles (NDC 0008-0836-21) UPC 3 0008-0836-21 7; b) 90-count Unit of Use bottles (NDC 0008-0836-22) UPC 3 0008-0836-22 4; Rx only, Distributed by Wyeth Pharmaceuticals Inc., A subsidiary of Pfizer Inc., Philadelphia, PA 19101. Lot #: a) V130142, Exp 10/15; b) V130140, Exp 10/15 Class I Presence of Foreign Tablets/Capsules: A Pharmacist reported that a bottle of Effexor XR 150 mg capsules contained a single peach colored capsule printed TKN250 which was identified as a Tikosyn (dofetilide) capsule. Pfizer Us Pharmaceutical Group
Devices VITROS TT4 Calibrator For the quantitative measurement of total thyroxine (T4) in human serum and plasma (EDTA or heparin) using the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic System and the VITROS 5600 Integrated System to aid in the differential diagnosis of thyroid disease. Catalog Number: 139 3396, Lot Number: 1590 Class II Total T4 Calibrators and Reagent Packs may have calibration failures or low Quality Control results. Ortho-Clinical Diagnostics
Devices Dimension Vista® CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantitative measurement of cyclosporine A (CSA) in human whole blood on the Dimension Vista® System. Measurements of CSA are used as an aid in the management of heart, liver and kidney transplant patients. CSA 13114BA, exp. 2014-04-24; CSA 13157BA, exp. 2014-06-06; CSA 13246BB, exp. 2014-09-03; CSA 13317BA, exp. 2014-11-13; CSA 14008BB, exp. 2015-01-08; CSA 14050BB, exp. 2015-02-19; CSAE 13157BC, exp. 2014-06-06; CSAE 13249BD, exp. 2014-09-06. Class II A complaint was received of Dimension Vista® CSA and CSAE under-recovery of cyclosporine when patient samples are run from the Small Sample Container. The under-recovery that has been observed is 18 to 44% Siemens Healthcare Diagnostics, Inc.
Food PDP reads in part "***GOOD FOOD MADE SIMPLE***breakfast in a bowl *** SOUTHWESTERN VEGGIES***" UPC 0 80618 41801 5 0214 Best By: January 21, 2015 Class III Raw material supplier accidently added sodium benzoate to the salsa used in manufacturing the finished product. Sodium benzoate was not declared on the ingredient statement of both the raw material and finished product. J. R. Simplot Co. Corporate HQ
Drugs INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960 TE38139, Exp. 08/16, TE39022, Exp. 09/16, Class II CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements. Teva Pharmaceuticals USA
Devices Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump Product Usage: The Intra-Aortic Balloon Pump (IABP) is an electromechanical system used to inflate and deflate intra-aortic balloons in cardiovascular procedures. IABP Model Numbers System 98 0998-00-0446-xx 0998-UC-0446-xx System 98XT 0998-00-0479-xx 0998-UC-0479-xx CS100i 0998-UC-0446Hxx 0998-UC-0479Hxx CS100 0998-00-3013-xx 0998-UC-3013-xx CS300 0998-00-3023-xx 0998-UC-3023-xx Class I Potential mechanical failure of the fan assembly associated with the power supply. A fan assembly failure could result in the power supply overheating and cause the IABP to shut down without warning. Maquet Datascope Corp - Cardiac Assist Division
Devices Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF. MF2016829 RM2072044 RM2034076 RM2095792 RM2056629 RM3015571 RM2069733 Class II The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe; however, the kit contains, and should state, Introducer Needle: 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe. As a result of this labeling inconsistency, if the clinician were to place the needle under x-ray with the assumption that the component was echogenic, the needle would appear less prominently than expected but would still be visible. Arrow International Inc
Food "Emparedados Boricua, Pollo & Queso (Chicken & Cheese), Net Wt. 6.5 oz, Elaborated and Distributed by Emparedados Boricua, Bayamon, PR, 00956" No codes are used Class I Undeclared eggs in Chicken (fully cooked)/Cheese sandwich. Emparedados Boricua
Food "Emparedados Boricua, Cubano (Pork, Ham and Cheese Sandwich), net Wt. 7.6 oz (220 g), Elaborated and Distributed by Emparedados Boricua, Bayamon, PR, 00956" No codes are used Class II Undeclared soy coming from the Cheese Swiss. Emparedados Boricua
Food "Emparedados Boricua, Media Noche (Pork, Ham and Cheese Sandwich), Net Wt. 7.6 oz (220g), Elaborated and Distributed by Emparedados Boricua, Bayamon, PR, 00956" No codes are used Class II Undeclared soy coming from the Cheese Swiss. Emparedados Boricua
Food "Emparedados Boricua, Tripleta (Turkey Pastrami, Turkey, Ham and Cheese Sandwich), Net Wt. 8 oz. (230g), Elaborated and Distributed by Emparedados Boricua, Bayamon, PR, 00956" No codes are used Class II Undeclared soy coming from the Cheese Swiss. Emparedados Boricua
Devices Esmark Elastic Bandage (Sterile), 4" x 9'. Item DYNJ05116A, Individually wrapped, 20 bandages per case. Packaged by Medline Industries Inc. This product is used as an elastic bandage to support and compress a part of a patient's body. It is also used as a tourniquet to restrict blood flow to a part of a patient's body. Product Number: DYNJ05116A . Lot Number: 13LA1009. Class II This lot did not go through the correct sterilization procedures. This product may potentially be non-sterile. Medline Industries Inc
Biologics Red Blood Cells Leukocytes Reduced W038113344953, W038113272643 Class III Blood products, collected from a donor with Erythrocytosis, were distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W201214038268 Class II Blood product, collected from a donor with an incomplete donor suitability determination, was distributed. The American National Red Cross - Southern Region
Biologics Cryoprecipitated AHF, Pooled W20041390225800; W20041390224800; W20041390215400; W20041390212900; W20041390223700; W20041390215200; W20041390223800; W20041390225300; W20041390216000; W20041390224400; W20041390225000; W20041390224500; W20041390215500; W20041390224200; W20041390221400; W20041390215700; W20041390213600; W20041390214600; W20041390224000; Class III Pool Cryoprecipitated AHF, not meeting quality control specifications, were distributed. Arc Blood Services, New England Region
Devices Naturalyte Liquid Bicarbonate Concentrate, 6.4 Liter Bottle Part Number: 08-4000-LB The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates Lot Numbers (49 lots) recalled on 4/10/14: 13KMLB001 13LMLB001 14AMLB002 13KMLB002 13LMLB002 14AMLB003 13KMLB003 13LMLB003 14AMLB004 13KMLB004 13LMLB004 14AMLB005 13KMLB005 13LMLB005 14AMLB006 13KMLB006 13LMLB006 14AMLB007 13KMLB007 13LMLB007 14AMLB008 13KMLB008 13LMLB008 14AMLB009 13KMLB009 13LMLB009 14AMLB010 13KMLB010 13LMLB010 14AMLB012 13KMLB011 13LMLB011 13JMLB005 13KMLB012 13LMLB012 13JMLB008 13KMLB013 13LMLB013 13JMLB006 13KMLB014 13LMLB014 13JMLB007 13KMLB015 13LMLB015 13JMLB004 13KMLB016 13LMLB016 13KMLB017 14AMLB001 Expanded Recall (9 lots): 13LMLB005 13LMLB006 14AMLB011 14AMLB013 14AMLB014 14AMLB015 14AMLB016 14AMLB017 14BLMB001 Class I Naturalyte Liquid Bicarbonate maybe contaminated Fresenius Medical Care Holdings, Inc.
Devices Lithium Ion Battery M4605A and M4607A for use with IntelliVue Patient Monitors. The monitor is used for monitoring and recording of, and to generate alarms for, multiple physiological parameters. Patient Monitor Product numbers M3002A, M8102A, M8105A, M8001A, M8002A, M8003A, M8004A, M8027A, M8001AU, M8002AU, M8003AU, and M8004AU with software releases up to and including G.0. Class II The risk of battery failure increases with age, when a battery remains in use longer than 3 years after date of manufacture or 500 charge-discharge cycles. Such failure can result in overheating that in rare cases can cause the battery to ignite or explode. Philips Medical Systems, Inc.
Devices JK Bariatric Beds, True Air Technologies, Inc. Serial #'s 41160, 10127, 09504, 41918, 106800, 62188, 106805, 42331, 106751, 00234A, 62422, 7987, 50147, 7111, 11151100, BB111, 00284A, 2171269, 62383, 4731, 4732, 4733, 4734, 4735 Class II The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors. SCM True Air Technologies LLC
Devices ECATS E 850 Bariatric Bed, True Air Technologies, Inc. Serial #'s E510, 506, 503, 515, 518, 10050, 512, 519, E9141, E9150, E9160, E9149, E9137, E5107, E9162, E9165, E9170, E9147, E5323, E520, E9171. E9149, E9516, E9140, 10051, 507, 508, 502, 504, 501, 514, 522, E9139, E10099, E525, 10052, E9148, E9161, E511, E9144, E914, E526, E500, E521, E9166, E530, E529 &  ...
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Class II The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors. SCM True Air Technologies LLC
Devices MaXair True Low Air Loss Mattress Replacement System, True Air Technologies, Inc. Serial #'s 2054, 2055, 2056, 2057, 2058, 2059, 2060, 2061, 2062, 2063, 2067, 2068, 2069, 2070, 2071, 2072, 2073, 2074, 2075, 2076, 2077, 2078, 2079, 2080, 2081, 2082, 2083, 2084, 2085, 2086, 2087, 2088, 2089, 2090, 2091, 2092, 2093, 2094, 2095, 2096, 2097, 2100, 2101, 2102, 2103, 2106, 2107, 2108,  ...
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Class II The firm is recalling the products due to lack of design controls, lack of a Device Master Record, and failure to approve specific vendors. SCM True Air Technologies LLC
Biologics Cornea SDS140312ODCN; SDS140312OSCN Class III Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. DCI Donor Services dba Sierra Donor Services
Biologics Source Plasma DQ301025, DQ300353, DQ299886, DQ299192, DQ298383, DQ297813, DQ296743, DQ295827, DQ295314, DQ294975, DQ294452, DQ294076, DQ291257, DQ290037, DQ288893, DQ288190, DQ287969, DQ287306, DQ287041, DQ286455, DQ286264 Class II Blood products, collected from a donor who was previously deferred for high risk behavior, were distributed. Plasma Biological Services Inc
Biologics Platelets Pheresis Leukocytes Reduced W115114030671C Class II Blood product, which had a low pH value, was distributed. LifeSouth Community Blood Centers, Inc.
Biologics Human Immunodeficiency Virus Type 1 and/or HCV and/or HBV (Nucleic Acid Pooled Testing/Syn) 624104; 614564 Class III In-vitro diagnostics, with mixed master lots, were distributed. Gen-Probe Inc
Devices 550 TxT Treatment Table of the Digital Linear Accelerator (LINAC) To deliver X-ray radiation for therapeutic treatment of cancer. material #8139789 , 5857912, 7360717, 1940035, 8139789, 4504200, 5863472, serial # 5377, 5087, 70-4262, 5170, 5282 5506 3287 5527 5517 70-4378 3695 5364 5060 5205 5688 5743 70-4283 5190 5157 5343 5844 5148 5391 5300 70-4296 5474 70-4363 70-4368 3793 3817 5833 5899 5207 5355 70-4159 3524 5281 5894 5374 5558 3631 3835 5784 2765 5367 70-4354 70-4356 5540 5488 5590 5657 5350 5821 3413 5222 5843 5179 70-4129 5851 5098 5153 5700 5410 3825 5865 5118 5548 3769 5861 70-4188 5748 70-4317 5737 5830 5385 5656 3778 5088 5665 5823 5353 5630 5480 5096 5572 3873 5417 4059 5500 5388 70-4379 5226 5601 5640 5033 5177 5707 5398 4091 5532 70-4306 70-4161 5424 5755 5326 5145 5699 4079 4082 70-4077 70-4113 5525 5419 3975 5093 5481 5396 3089 5095 5154 Class II Table may lose calibration during patient treatment, which may cause the possibility of mistreatment. Siemens Medical Solutions USA, Inc
Devices MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporation. x-ray generator SN: MXA1170108, MXA1270262 Class II The MXR-35 X-ray Generator's labeling did not include the certification statement as required by 21 CFR Part 10 10.2. Fujifilm Medical System USA, Inc.
Drugs phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North America, Waltham, MA 02451, NDC 0781-2081-02 Lot # 13064, 13065, 13066; Exp. 08/18 Class II Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical analysis of the contaminant found on the cotton was identified as a formulation of 4% Trimipramine methanesulfonate - a tricyclic antidepressant.. Fresenius Medical Care Holdings, Inc.
Devices Polyflux Revaclear, Capillary Dialyzer, Model Number 110633; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis. Lot Numbers: C413124101, C413124301, C413124501, C413124601, C413124701, C413124801, C413124901, C413125001, C413125101, C413125201, C413125301, C413125401, C413125501, C413125601, C413125701, C413125801, C413125901, C413126001, C413126101, C413126201, C413126301, C413126401, C413126501, C413126601, C413126701, C413126801, C413126901, C413127001, C413127101, C413127201, C413127301, C413127401, C413127501, C413127601, C413127701, C413127801, C413127901, C413128001, C413128101, C413128201, C413128401, C413128501, C413128601, C413128701, C413128801, C413128901, C413129001, C413129101,  ...
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Class II The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013. Gambro Renal Products, Incorporated
Devices Polyflux Revaclear Max, Capillary Dialyzer, Model Number 110634; Gambro Renal Products, Inc. Intended for the treatment of acute and chronic renal failure by hemodialysis. Lot Numbers: C413204601, C413204801, C413204901, C413205101, C413205201, C413205301, C413205401, C413205501, C413205601, C413205701, C413205801, C413205901, C413206001, C414200101, C414200201, C414200301, C414200401, C414200701, C414200801, C414200901, C414201301, C414201401, C414201501, and C414201601. Class II The firm received several complaints for internal blood leaks involving various lot numbers produced in late 2013. Gambro Renal Products, Incorporated
Devices Infant Nasal CPAP (continuous positive airway pressure) Prong, Nasal. CPAP Prongs (10 pack): Model No. BC3020-10, BC3520-10, BC4030-10, BC4540-10, BC5040-10, BC5050-10, BC5550-10, BC5560-10, BC6060-10, BC6070-10, BC6570-10. Bubble CPAP Starter Kits: Model No. BC461-SK, BC471-SK, BC490-SK, BC491-SK, BC492-SK. The Nasal CPAP Prongs connect to the FPH FlexiTrunk Patient Interface. Nasal CPAP Prongs (10 pack), Lot Numbers 13060603XX through 14032503XX; 13082003XX through 14032503XX; 13091903XX through 14032503XX; 13082603XX through 14032503XX; 13091903XX through 14032503XX; 14022603XX through 14032503XX; 14022603XX through 14032503XX; 14031203XX through 14032503XX; 14031203XX through 14032503XX; 14031203XX through 14032503XX; 14031203XX through 14032503XX. Bubble CPAP Starter Kits, Lot No. 131007 through 140325. Class I Fisher and Paykel Healthcare is recalling the Infant Nasal CPAP Prong because it has the potential to detach from the Nasal Tubing and therapy is likely to be interrupted. Fisher & Paykel Healthcare, Ltd.
Devices Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper Forceps Tips are intended to cut, grasp, and dissect various abdominal tissue for use in endoscopic, including laproscopic surgical procedures where instruments are introduced onto the body through a cannula. Lot Numbers: 00116169 and 00115866 Class II Grasper jaw may break when force is applied to the jaw Microline Surgical
Devices Anspach Irrigation Clip 40 Product Usage: Irrigation clips provide a method of supplying controlled, cooling irrigation during cutting, shaping, and removal of bone, including bones of the skull and spine. Batch G323082757. Class II The Irrigation Clips were assembled with the incorrect (smaller) clips. The Anspach Effort, Inc.
Devices TRIGEN INTERTAN NAIL: (1) REF 71675201, 10 MM X 18 CM, 125 degree, (2) REF 71675202, 11.5 MM X 18 CM, 125 degree, (3) REF 71675203, 13 MM X 18 CM, 125 degree, (4) REF 71675204, 10 MM X 20 CM, 125 degree, (5) REF 71675205, 11.5 MM X 20 CM, 125 degree, (6) REF 71675207, 10 MM X 18 CM, 130 degree, (7) REF 71675208, 11.5 MM X 18 CM, 130 degree, (8) REF 71675211, 11.5 MM X 20 CM, 130 degree, Smith & Nephew, Inc. Orthopedic fixation device. (1) REF 71675201, Lot Numbers: 13LT36305, 13LT36306, 13LT36547, 13LT36548, 13LT37009, 13LT37010, 13MT37347, 13MT37665, 13MT37667, 13MT37668, 14AT38179, 14AT38180, 14AT38181, 14T38182, 14AT38183, 14AT38189, 14AT38190 (2)  ...
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Class II A manufacturing error resulted in the set screw being inserted too deep in the affected nails. Smith & Nephew Inc
Devices TRIGEN INTERTAN 1.5 NAIL: (1) REF 71676515, 10 MM X 10 CM, 125degree, LEFT, (2) REF 71676556, 11.5 MM X 36 CM, 125degree, RIGHT, (3) REF 71676558, 11.5 MM X 38 CM, 125degree, RIGHT, (4) REF 71676561, 11.5 MM X 42 CM, 125degree, LEFT, Smith & Nephew, Inc. Orthopedic fixation device. (1) REF 71676515, Lot Number 13LT36602 (2) REF 71676556, Lot Numbers: 13LT36604, 13MT37354, 13MT37947, 14AT38705, 14AT38714 (3) REF 71676558, Lot Numbers: 13KT36282, 13MT37356, 13MT37664, 13MT37949, 14AT38187 (4) REF 71676561, Lot Numbers: 13LT36605, 13MT37358, 14AT38188 Class II A manufacturing error resulted in the set screw being inserted too deep in the affected nails. Smith & Nephew Inc
Biologics Cornea 111710ODC; 111710OSC Class II Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Minnesota Lions Eye Bank, Inc
Drugs BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5. Lot #: 34013132A, 34013133A, 34013134A, 34013135A, 34013136A, Exp 11/14 Class II Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing. Teva Pharmaceuticals USA
Drugs BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 8 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5379-56, UPC 3 0093-5379-56 2. 34009367B, 34009368B, 34009369A, 34009370B, Exp 04/14; 34013141A, 34013142A, Exp 11/14; 34016682A, 34016683A, 34016684A, 34017000A, 34017001A, Exp 08/15 Class II Failed Impurities/Degradation Specifications: High out of specification impurity test results were obtained during stability testing. Teva Pharmaceuticals USA
Devices SW-2008 Snuggle Warm Sterile Cardiac Connective Warming Blanket; used with the Equator Convective Warmer, are intended for thermal regulation of a patient's temperture and are designed to prevent hypothermia and/ or reduce cold discomfort during and after surgical procedures. Lot: 1006733, 2474599, 2488138, 2523531, 2536250, 2558180, 2563033, 2564447, 2564448, 2615712 Class II The hose could separate from the blanket. Smiths Medical ASD, Inc.
Devices syngo Imaging XS Syngo Imaging XS is a Picture Archiving and Communication System (PACS) intended to display, process, read, report, communicate, distribute, store and archive digital medical images. It supports the physician in diagnosis and treatment planning. Syngo Imaging XS also supports storage and archiving of Structured DICOM reports. Syngo Imaging XS optionally uses a variety of advanced postprocessing applications. material number: 10014063, with serial numbers: 1334 1065 1351 1491 1417 1269 1076 1043 1429 1353 1392 1258 1398 1445 1496 1279 1116 1090 1229 1080 1005 1081 1310 1246 1226 1057 1379 1396 1084 1322 1107 1453 1124 1343 1198 1432 1058 1247 1278 1082 1055 1049 1329 1203 1490 1083 1316 1395 1053 1079 1387 1448 1218 1451 1389 1386 1064 1500 1436 1074 1443 1210 1408 1427 Class II A complaint reported that the archiving method at one customer site was changed from implicit to explicit, and the cleanup procedure enabled by the explicit archivingmethod may have deleted data from archive itself. Siemens Medical Solutions USA, Inc
Food Verdex Fresh Snow Peas packed in 10 pounds cartons, keep refrigerated, Lot # 2161100811 product from Guatemala Lot # 2161100811 Class III Unapproved fungicide residue detected on random sample. Carbendizam at 28 ppb Harvest Sensations LLC
Drugs QVAR® (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalations/120 metered inhalations, packaged in an aluminum cylinder, Mktd. by: Teva Respiratory, LLC, Horsham, PA, Mfd. by: 3M Drug Delivery Systems, Northridge, CA. 130140 11/2014 59310-204-85 80 mcg 4.2g / 50 metered inhalations 130143 3/2015 59310-204-80 80 mcg 8.7g / 120 metered inhalations 130144 3/2015 59310-204-80 80 mcg 8.7g / 120 metered inhalations Class II Defective Delivery System; defective valve Teva Pharmaceuticals USA
Drugs Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-count bottle NDC 42794-018-06, SigmaPharm Laboratories, LLC, Bensalem, Pa. Lot #s: a) 1302201, Exp 01/2015; 1305501, Exp 03/2015; 1314801, Exp 10/2015; b) 1302202, Exp 01/2015 Class II Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously manufactured product. SigmaPharm Laboratories LLC
Devices LATEX-FREE; EXTENSION SET; For Bladder Irrigation or Urinary Drainage, Compatible with T-U-R FLOW-POUCH RESERVOIR, list 6542, 71 inch (180 cm) Nominal Length; List No. 4693-01; single use; Hospira Product Usage: Bladder irrigation or urinary drainage List No. 4693-04-01 (4693-01); Lot Numbers: 16119NS, 17186NS, 21134NS, 25129NS Class II The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack. Hospira Inc.
Devices LATEX-FREE; T-U-R Y-Set; Nonvented Set for Transurethral Resection Procedures; 96 inch (244 cm); For Flexible Irrigation Container Systems; List No. 6543-01; single use; Hospira Product Usage: For use in transurethral resection procedures List No. 6543-04-01 (6543-01); Lot Numbers: 13106NS, 13170NS, 13251NS, 14261NS, 14262NS, 15139NS, 16117NS, 17131NS, 17132NS, 17184NS, 18110NS, 18111NS, 18182NS, 19133NS, 20122NS, 20123NS, 20124NS, 20205NS, 22146NS, 22147NS, 22148NS, 22149NS, 23103NS, 23104NS, 23105NS, 23106NS, 24156NS, 25130NS, 25131NS, 27109NS, 27253NS, 27286NS, 28136NS, 28137NS, 29094NS, 29095NS, 29096NS, 30194NS, 30195NS, 30196NS, 31042NS, 31043NS, 32229NS, 32230NS,  ...
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Class II The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack. Hospira Inc.
Devices LATEX-FREE; CYSTOSCOPY/IRRIGATION SET; Nonvented, 77 inch (195 cm) for Constant or Intermittent Bladder Irrigation; For Use with Flexible Irrigation Container System; List No. 6544-01; Hospira Product Usage: For Constant or Intermittent Bladder Irrigation List No. 6544-04-01 (6544-01); Lot Numbers: 13107NS, 13108NS, 13171NS, 13172NS, 15141NS, 15142NS, 15143NS, 16113NS, 16114NS, 16115NS, 16116NS, 16174NS, 16175NS, 16176NS, 17134NS, 18112NS, 19130NS, 19131NS, 19132NS, 20119NS, 20120NS, 20121NS, 21130NS, 21131NS, 21207NS, 22144NS, 22145NS, 23107NS, 23108NS, 23109NS, 23110NS, 23111NS, 23112NS, 24194NS, 24204NS, 25133NS, 25254NS, 27110NS, 27111NS, 27155NS, 28192NS, 28271NS, 28272NS, 29097NS,  ...
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Class II The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack. Hospira Inc.
Devices LATEX-FREE; LARGE BORE Y-IRRIGATION SET; Nonvented Set; 100 inch (254 cm); For Flexible Irrigation Container Systems; List No. 6599-01; single use; Hospira Product Usage: For Use With Flexible Irrigation Container Systems List No. 6599-04-01 (6599-01); Lot Numbers:12145NS, 12146NS, 16120NS, 17130NS, 18113NS, 19134NS, 20196NS, 21132NS, 24120NS, 25134NS, 25211NS, 27112NS, 28273NS, 28274NS, 29098NS, 31040NS, 32296NS, 33142NS, 34143NS Class II The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack. Hospira Inc.
Devices LATEX-FREE; 4-LEAD T-U-R IRRIGATION SET; Nonvented Set for Transurethral Resection Procedures; 85 inch (216 cm); For Flexible Irrigation Container Systems; List No. 15239-01; Single Use; Hospira Product Usage: For Transurethral Resection Procedures List No. 15239-04-01 (15239-01); Lot Numbers: 13259NS, 17185NS, 18181NS, 23102NS, 27108NS, 28275NS, 29093NS, 31041NS Class II The Tyvek cover may not be completely sealed to the rest of the package allowing openings at the edge of the sterile package for the following products: List No. 04693-01, Latex Free Extension Set; List No. 06543-01, Nonvented Y-Set for Transurethral Resection; List No. 06544-01 Cystoscopy / Irrigation Set; List No. 06599-01, Large Bore Y-Irrigation Set (Latex-Free); and, List No. 15239-01, 4-Lead TUR Irrigation Set. Hospira has received complaints of the sterile pack not sealed properly or the Tyvek cover sheet not centered on the bottom tray of the pack. Hospira Inc.
Food Meijer Baby Pediatric Electrolyte Fruit Flavor 8oz x 4 with Best by: 10/01/15; 24 bottles per case, 6-4packs Lot # P0127413 Class II H:20 Innovations is recalling Meijer Brand Baby Pediatric Electrolyte Fruit and Strawberry Flavor 8oz drinks due to a seal defect found during a complaint investigation. H:20 Innovations LLC
Food Meijer Baby Pediatric Electrolyte Strawberry Flavor 8oz x 4 with Best by: 10/02/15; 24 bottles per case, 6-4packs Lot # P0127513 Class II H:20 Innovations is recalling Meijer Brand Baby Pediatric Electrolyte Fruit and Strawberry Flavor 8oz drinks due to a seal defect found during a complaint investigation. H:20 Innovations LLC
Food Stonyfield YoBaby Pear/Peach Organic Whole Milk Yogurt multipack- 6 pack plastic cups- 3 peach and 3 pear/4 oz each cups UPC-052159701161 Code Date: June 05 2014 Class II Product has elevated levels of coliforms Stonyfield Farm
Food Stonyfield YoBaby Vanilla Organic Whole Milk Yogurt multipack 6 pack plastic cups/4 oz each UPC-052159701178 Code Date: June 05 2014 Class II Product has elevated levels of coliforms Stonyfield Farm
Food Stonyfield YoToddler Raspberry/Pear Cereal Organic Whole Milk Yogurt with Fruit and Cereal, multipack 6 pack plastic cups/4 oz each UPC-052159701215 Code Date: June 05 2014 Class II Product has elevated levels of coliforms Stonyfield Farm
Food Bolivian Artichoke Salad sold at Whole Foods 10 lb bulk bags, refrigerated Sell By : 05/02/2014 Class II Potential for foreign material -glass Whole Foods Market Group Inc.
Biologics Source Plasma GN0423685, WN0424245 Class II Blood products, which were not quarantined after receiving post donation information concerning receipt of a tattoo, were distributed. DCI Biologicals, Orlando LLC
Food Blue Bunny Premium Ice Cream, Bordeaux Cherry Chocolate, 1.75 quart. Packaged in 4/56-oz carton cases. Item # 745152, UPC 070640034123. Manufactured by Wells Enterprises, Inc., Le Mars, IA. Lot 40010 TTT 19115 4100, Best Used by 10/9/15 Class I The product may contain egg which is not listed on the ingredient label. Wells Enterprises, Inc.
Drugs Red Yeast Rice High Potency Dietary Supplement, 600 mg, packaged in a) 120-count VegeCaps per bottle (UPC 8 01650 02205 9) and b) 500-count VegeCaps per bottle (UPC 8 01650 02206 6), Manufactured by: Back to Health, Eugene, Oregon 97402. Lot #: 1402009; 1312008; 1309017; and 1308009 Class II Marketed Without An Approved NDA/ANDA: Product is being recalled due to excessive levels of lovastatin. Lovastatin is an FDA approved drug making this dietary supplement an unapproved new drug. Independent Nutrition Center, Inc.
Food On cap 100% Spring Water Bottled at Aqua Filter Fresh, Inc., Pittsburgh, PA 15239 Source Boiling Spring, Oakland, MD 21550 On bottle side: Tyler Mountain Water & Coffee In 3 gallon and 5 gallon plastic bottles MFG 041714 EXP 041715 MFG 041814 EXP 041815 Class II For Spring Water and Purified Water bottled 4/17 - 18/2014, Outside lab results were positive for Coliforms non-speciated E. coli. Aqua Filter Fresh, Inc.
Food On cap Purified Water Bottled at Aqua Filter Fresh, Inc., Pittsburgh, PA 15239 Permit #504 Source: Plum Boro Municipal Authority 15239 Processed by Reverse Osmosis, Steam Distillation, Micro-filtration, Ozonation, UV *Minerals added for taste On Bottle side: Tyler Mountain Water & Coffee In 4 gallon and 5 gallon plastic bottles MFG 041714 EXP 041715 MFG 041814 EXP 041815 Class II For Spring Water and Purified Water bottled 4/17 - 18/2014, Outside lab results were positive for Coliforms non-speciated E. coli. Aqua Filter Fresh, Inc.
Biologics Red Blood Cells Leukocytes Reduced W043213105076 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Blood Assurance Inc
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W050914007799 Class II Blood products, which were not tested for pH and platelet count, were distributed. HCSC-Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W050914007799 Class II Blood products, which were not tested for pH and platelet count, were distributed. HCSC-Blood Center
Food Lipton Pure Leaf Iced Tea Unsweetened 18.5OZ PL 6 Pack and 12 Pack Item # 133244 (6 pk) and Item # 134072 (12 pk) with codes: XXXXGG03034, XXXXGG03044, and XXXXGG03054. Manufactured on: 03/03/14, 03/04/14, and 03/05/14. BTL: Oct 06 14 Code Interpretation as follows: OCT 06 14 XXXXGG03034 Where: OCT 06 14 = End Date XXXX= Military Time (0000-2359) GG = Plt. Designator 03034= Prod Date (03/03/14) Class II Pepsi Co has announced a recall of some Lipton Pure Leaf Iced Tea products produced on March 3, 4, 5, and 6th of 2014 due to recent consumer complaints regarding apparent mold in the product. Pepsi Beverages Company
Food Lipton Pure Leaf Iced Tea Sweet Tea 18.5OZ PL 6 Pack Item # 133245 (6 pk) with codes: XXXXGG03064 Manufactured on: 03/06/14 BTL: Oct 06 14 Code Interpretation as follows: OCT 06 14 XXXXGG03034 Where: OCT 06 14 = End Date XXXX= Military Time (0000-2359) GG = Plt. Designator 03034= Prod Date (03/03/14) Class II Pepsi Co has announced a recall of some Lipton Pure Leaf Iced Tea products produced on March 3, 4, 5, and 6th of 2014 due to recent consumer complaints regarding apparent mold in the product. Pepsi Beverages Company
Food Lipton Pure Leaf Iced Tea Lemon 18.5OZ PL 6 Pack Item # 133246 (6 pk) with codes: XXXXGG03034 and XXXXGG03044 Manufactured on: 03/03/14 03/04/14 BTL: Sep 08 14 Code Interpretation as follows: OCT 06 14 XXXXGG03034 Where: OCT 06 14 = End Date XXXX= Military Time (0000-2359) GG = Plt. Designator 03034= Prod Date (03/03/14) Class II Pepsi Co has announced a recall of some Lipton Pure Leaf Iced Tea products produced on March 3, 4, 5, and 6th of 2014 due to recent consumer complaints regarding apparent mold in the product. Pepsi Beverages Company
Food Lipton Pure Leaf Iced Tea Lemon 18.5OZ PL 12 Pack Item # 134073 (12 pk) with codes: XXXXGG03034, XXXXGG03044,and XXXXGG03064. Manufactured on: 03/03/14, 03/04/14, and 03/06/14 BTL: Sep 08 14 Code Interpretation as follows: OCT 06 14 XXXXGG03034 Where: OCT 06 14 = End Date XXXX= Military Time (0000-2359) GG = Plt. Designator 03034= Prod Date (03/03/14) Class II Pepsi Co has announced a recall of some Lipton Pure Leaf Iced Tea products produced on March 3, 4, 5, and 6th of 2014 due to recent consumer complaints regarding apparent mold in the product. Pepsi Beverages Company
Food Lipton Pure Leaf Iced NTS Honey Green Tea 12 Pack Item # 137642 (12 pk) with codes: XXXXGG03044 Manufactured on: 03/04/14 BTL: Jun 30 14 Code Interpretation as follows: OCT 06 14 XXXXGG03034 Where: OCT 06 14 = End Date XXXX= Military Time (0000-2359) GG = Plt. Designator 03034= Prod Date (03/03/14) Class II Pepsi Co has announced a recall of some Lipton Pure Leaf Iced Tea products produced on March 3, 4, 5, and 6th of 2014 due to recent consumer complaints regarding apparent mold in the product. Pepsi Beverages Company
Food Lipton Pure Leaf Iced NTS Peach Tea 12 Pack Item # 137643 (12 pk) with codes: XXXXGG03044 Manufactured on: 03/04/14 BTL: Sept 08 14 Code Interpretation as follows: OCT 06 14 XXXXGG03034 Where: OCT 06 14 = End Date XXXX= Military Time (0000-2359) GG = Plt. Designator 03034= Prod Date (03/03/14) Class II Pepsi Co has announced a recall of some Lipton Pure Leaf Iced Tea products produced on March 3, 4, 5, and 6th of 2014 due to recent consumer complaints regarding apparent mold in the product. Pepsi Beverages Company
Devices MAMMOMAT Inspiration. Intended for mammography exams, screening, diagnosis, and stereotactic biopsies under the supervision of medical professionals. (Material number 10549894) with serial numbers 5000 through 5029. Class II There is a potential and possible hazard to the user when using the MAMMOMAT Inspiration PC monitor at the control desk, in that the holder of the PC monitor can break causing an unstable monitor to fall causing possible serious injury. Siemens Medical Solutions USA, Inc
Devices CDI Blood Parameter Monitoring System; Catalog Numbers or Part Numbers - 145891, 500AVHCT; Serial Numbers - BPM SN B015552 (installed into CDI 500 Monitor SN 3535) Catalog Number or Part Number 145891 500AVHCT Serial Number: BPM SN 8015552 (installed into CDI 500 Monitor SN 3535) Class II There is a potential for inaccuracies in blood gas readings/measurements. There is a potential risk of respiratory alkalosis or cerebral vasoconstriction with low paCO2. If the Hemoglobin and Hematocrit measurements are not accurate, there is a potential risk of unnecesary blood transfusion with resulting risk of infection or inflammatory reaction. BPM shipped without meeting manufacturing acceptance criteria for a required drift test. Terumo Cardiovascular Systems Corporation
Biologics Cornea 20140084OD; 20140084OS Class III Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. International Sight Restoration, Inc.
Drugs Bystolic (nebivolol), 20 mg/tablet, 30 tablets per bottle, Rx only, Licensed from Mylan Laboratories Inc., Under license from Janssen Pharmaceutica NV, Belgium, Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, NDC 0456-1420-30 Lot: A287945, Exp: 08/2015 Class II Failed Dissolution Specifications: One lot of product is being voluntarily recalled because dissolution test results failed to meet specification throughout the product's shelf life. Forest Pharmaceuticals Inc
Devices Philips XRE, the dictation editor system included in the Philips XIRIS 8.1.50 XIRIS is a radiology information system (RIS) is a computer system that assist radiology services in the storing, manipulating and retrieving of patient information. This included patient scheduling and tracking and workflow and reporting management. Model XIRIS 8.1 version XIRIS 8.1.50.0 Class II When using XIRIS Rio version (8.1.50.0) in conjuncture with iSite PACS a synchronization error can occur and if not noticed, information for the incorrect patient may be displayed Philips Healthcare Informatics, Inc.
Drugs PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01 Lot #: MN9081, Expiry: 09/2015 Class II Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles. Zydus Pharmaceuticals USA Inc
Drugs Oasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distributed by: OASIS, OASIS Medical, Inc., Glendora, CA 91741. UPC: 8 54819 00002 3. Lot #: OTM-07, Expiry: 12/2015. Class III Labeling: Missing Label; The label on the immediate bottle is missing. Oasis Medical Inc
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