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U.S. Department of Health and Human Services

Enforcement Report - Week of July 30, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Drugs Taztia XT (Diltiazem HCl) Capsules, 120 mg, Rx, Packaged and labeled as Thiamine. Re-Packaged By: Shamrock Medical Solutions, Lewis Center, Ohio, Mfg: Watson Laboratories, Corona, CA NDC 62037-0696-90 Use By: 5/31/2013, Lot: 0021OC, NDC 62037-0696-90 Class I Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules Shamrock Medical Solutions Group LLC
Drugs Oxycodone HCl Oral Concentrate, 20 mg/mL, Rx (C-II) Packaged and labeled as Morphine Sulfate 20 mg/mL, Mfg: Lannett Co. Inc., Re-Packaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Cody Laboratories Inc., Cody, WY NDC 00527-1426-36 Lot #: 002HZI Use By: 7/20/2013 NDC: 00527-1426-36 Class I Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL Shamrock Medical Solutions Group LLC
Drugs metFORMIN ER Tablets, 500 mg, Rx, Packaged and labeled as metFORMIN Immediate Release (IR), Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfr: Amneal/Interpharm, Hauppauge, NY NDC 53746-178-01 Lot #: 00267J Use By: 7/28/2012 NDC: 53746-178-01 Class I Labeling: Label Mix up; product labeled did not indicated Extended Release Shamrock Medical Solutions Group LLC
Drugs Pramipexole Dihydrochloride Tablets, 0.5 mg, Rx, packaged and labeled to contain Nebivolol tablets, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Northstar Rx, Memphis, TN NDC 16714-586-01 Use by 12/14/2012, Lot# 002B90, NDC 16714-586-01 Class II Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets Shamrock Medical Solutions Group LLC
Drugs Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg, DOUBLE STRENGTH, Rx, packaged and labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Amneal/Interpharm, NDC 53746-272-01 Lot 00288N, Use By: 9/15/2012, NDC 53746-272-01 Class II Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg Shamrock Medical Solutions Group LLC
Drugs Docusate Calcium Softgel Capsules, 240 mg, OTC, packaged and labeled to contain Docusate Sodium 240mg, Repackaged By: Shamrock Medical Solutions Lewis Center, Ohio, Mfg: Major Pharmaceuticals, Livonia, MI NDC 00904-5779-60 Lot #: 002H79, Use By: 06/19/2013, NDC: 00904-5779-60 Class II Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg Shamrock Medical Solutions Group LLC
Food PRAN brand Spice Powder TURMERIC, Net Wt. 14.1 oz./400g, UPC 8 46656 00209 4, and Net Wt. 8.82 oz./250g, UPC 8 31730 00551 --- PRODUCT OF BANGLADESH -- Manufactured by/Fabricado por: PRAN AGRO LTD, PRAN-RFL Center, 105 Middle Badda, Dhaka-1212, Bangladesh --- This product is packed in clear plastic jars with yellow plastic lids. BEST BEFORE: 26 OCT 14 and BEST BEFORE: 15 JAN 15 Class I The product was found to contain excessive levels of lead based on sampling by New York State Department of Health, private laboratory analysis, and FDA sampling and analysis. Ontime Distribution Inc.
Food PRAN brand Spice Powder TURMERIC, Net Wt. 8.82 oz./250g, UPC 8 31730 00551 --- PRODUCT OF BANGLADESH -- Manufactured by/Fabricado por: PRAN AGRO LTD, PRAN-RFL Center, 105 Middle Badda, Dhaka-1212, Bangladesh --- This product is packed in a clear plastic jar with a yellow plastic lid. DATE CODE: BEST BEFORE: 02 SEP 14 Class I The product was found to contain 28 ppm lead based on sampling by New York State Department of Health and private laboratory analysis Asia Cash & Carry Inc.
Food PRAN TURMERIC POWDER 400 GM plastic bag MFG:27 OCT 12; and Best Buy 26 OCT 14 UPC 8-31730-00502-3 Class I Best Value Inc imported PRAN Spice Powder TURMERIC and distributed to retail stores. FDA sample was found to contain excessive levels of Lead above 53.7ppm. Best Value Inc
Food Pran Spice Powder Turmeric , 14.10 oz. (400g) clear plastic laminated pouch, UPC 8 3173000502 3 Best Before 25 JAN 15 Class I Elevated levels of lead. Fahman Enterprises, Inc
Veterinary The Acclaim Encore is designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers. List Number: 12569. Serial Numbers: 13733228 , 13734668  ...
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Class II Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. When the door is closed properly, the door functions to ensure that the tubing is seated properly to ensure appropriate flow. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy. Hospira Inc.
Veterinary The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual. List Number: 60529; Serial Numbers: 14315003 , 14315004  ...
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Class II There is the potential for the distal (occlusion) pressure sensor pin to break on Plum A+ infusers. The distal pressure sensor pin is a part of the overall subsystem that measures the pressure within the distal line of the administration set and indicates the presence of a full or partial distal occlusion. A broken distal pressure pin can only be detected via a visual inspection of the distal pressure pin. Hospira Inc.
Veterinary The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual. List Number: 60529; Serial Numbers: 14315003 , 14315004  ...
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Class II Hospira has received reports related to distal pressure sensor calibration drift on Plum A+ Infusers. If the distal pressure sensor calibration has drifted, it will need to be recalibrated. The following error codes may be displayed during setup or infusion signifying possible calibration drift: E180/N180, E181/N181, E186/N186, E187/N187 or E346. Additionally, if the pressure sensor calibration has drifted, you may experience nuisance (false) distal occlusion alarms or distal occlusions that may not be detected. These errors invoke visual and audible warnings to the user. Hospira Inc.
Veterinary The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual. List Number: 60529; Serial Numbers: 14315003 , 14315004  ...
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Class II The is a possible interruption of therapy which may occur when in E321 error code occurs while using a Plum A+ infuser. The E321 error code occurs when the Plum A+ infuser is operating on AC power and the software detects that the batter could not be fully recharged within eight hours. If the E321 error code occurs during infusion, the infuser will stop delivery, which may result in a delay/interruption of therapy. Hospira Inc.
Veterinary The Acclaim Infusion Pump is designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers. List Number: 12032; Serial Numbers: 12322921 , 12323859 , 12322780 , 12322801 , 12322810 , 12322812 , 12322878 , 12322880 , 12322887 , 12322896 , 12322903 , 12322904 , 12322911 , 12322917 , 12322936 , 12322939 , 12323867 , 12322916 , 12323056 , 12321139 , 12324767 , 12324854 , 12324802 ,  ...
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Class II Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. When the door is closed properly, the door functions to ensure that the tubing is seated properly to ensure appropriate flow. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy. Hospira Inc.
Veterinary The Acclaim Infusion Pump is designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers. List Number: 12237; Serial Numbers: 12670196 , 12670182  ...
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Class II Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. When the door is closed properly, the door functions to ensure that the tubing is seated properly to ensure appropriate flow. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy. Hospira Inc.
Veterinary The Plum A+ Infusion System is designed to meet the fluid delivery requirements of today's evolving healthcare environments. It is a cassette based multi-function infusion system. The Plum A+ allows two lines in and one line out. The pump can be used for standard, piggyback, or concurrent delivery. Therapy modes include: Standard Infusions, Multistep Programming, Loading Dose, and Dose Calculation. The Plum A+ is designed to deliver parenteral, enteral, or epidural infusions over a broad range of infusion rates from multiple fluid container types. Each system includes a pumping module and an assortment of disposable IV sets, optional accessories, and an operator's manual. List Number: 60529; Serial Numbers: 14315004 , 14315005  ...
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Class II The door roller assembly on the Plum A+/A+3 infuser family of infusers has the potential to break, which can lead to possible unrestricted flor and/or overdelivery during the removal of the IV administration set's cassette from the pump. The IV administration set's cassette contains a flow regulator designed to close upon cassette removal to prevent accidental flow. In the event the door roller assembly is broken, the regulator closer may not close properly and unrestricted flow and/or overdelivery can occur which has the potential to contribute to life-threatening adverse events. Hospira Inc.
Devices ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE® Redi-Code+ BMB-BA006A Blood Glucose test strips are used only with the ADVOCATE® Redi-Code+ BMB-EA004S meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf, and the thigh. All test strips lots manufactured from June 01, 2012 to January 01, 2014.. No specific lot numbers provided. Class I "Advocate Redi-Code + BMB-BA006A Blood Glucose test strips" are inappropriately labeled and marketed as "Advocate Redi-Code + Blood Glucose test strips". DIABETIC SUPPLY OF SUNCOAST, INC.
Veterinary The LifeCare 5000 Pump (Plum 1.6) is indicated for accurate, volumetric infusion of critical drugs and fluids by intravenous (I.V.) administration. List Number: 02507; Serial Numbers: All. Class II There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion alarm might be triggered. Broken door roller pins can also cause the cassette door to be very loosely seated and, when jostled, may come out of position and stop infusion in the middle of therapy. And lastly, when the cassette door is opened, the cassette door mechanism may not fully clamp the IV tubing. Hospira Inc.
Veterinary The Plum XL Family is indicated for intravenous. arterial, sort-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments. List Number: 11555; Serial Numbers: All. List Number: 11855; Serial Numbers: All. List Number: 11859; Serial Numbers: All. Class II There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion alarm might be triggered. Broken door roller pins can also cause the cassette door to be very loosely seated and, when jostled, may come out of position and stop infusion in the middle of therapy. And lastly, when the cassette door is opened, the cassette door mechanism may not fully clamp the IV tubing. Hospira Inc.
Veterinary The Plum XL Family is indicated for intravenous. arterial, sort-term epidural, and parenteral administration of general I.V. fluids, medications, nutritional fluids, and blood/blood products to patients in hospital and home care environments. List Number: 11781; Serial Numbers: All. List Number: 11845; Serial Numbers: All. List Number: 11846; Serial Numbers: All. Class II There is the potential for the door roller assembly on the Plum LifeCare 5000 Series and Plum XL families of infusers to break. In the event of a broken door roller pin, the door cannot appropriately lock the cassette in the right position. Depending on the conditions of a broken door roller pin, a number of events can occur. The door cannot be closed or a cassette/door alarm or a false occlusion alarm might be triggered. Broken door roller pins can also cause the cassette door to be very loosely seated and, when jostled, may come out of position and stop infusion in the middle of therapy. And lastly, when the cassette door is opened, the cassette door mechanism may not fully clamp the IV tubing. Hospira Inc.
Food Label reads in part "Annie Mac's Baking Co. Coconut Macaroon, "The coconut macaroon is dipped in chocolate, heat sealed in plastic." Net Wt. 12 oz. Product is wrapped in cellophane Product does not contain any lot code Class I Ingredient statement for the Coconut Macaroon Cookie does not declare chocolate and its sub-ingredients, including soy lecithin and milk plus does not declare the sulfur dioxide in the coconut. Annie Mac's Baking Company
Devices NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement. Serial Numbers: 2910243, 2910244, 2910245, 2910246, 2910247, 2910248, 2910249, 2910250, 2910251, and 2910252 Class II The femoral stem is lacking specified plasma coating. Exactech, Inc.
Devices DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients. Serial # Model # 6837005 E-MINIC-00 6838210 E-MINIC-00 6845207 E-MINIC-00 6845218 E-MINIC-00 6845228 E-MINIC-00 6845248 E-MINIC-00 6860768 E-MINIC-00 6860858 E-MINIC-00 6876048 E-MINIC-00 6876050 E-MINIC-00 6876052 E-MINIC-00 6876054 E-MINIC-00 6878048 E-MINIC-00 6888716 E-MINIC-00 6888726 E-MINIC-00 6888755 E-MINIC-00 6889935 E-MINIC-00 6889950 E-MINIC-00 6891094 E-MINIC-00 6891114 E-MINIC-00 6891115 E-MINIC-00 6891116 E-MINIC-00 6891117 E-MINIC-00  ...
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Class I Failure of the CO2 detector in Single-width Airway and Extension modules, which may cause a slow continuous decrease of measured Et/Fi CO2 values. Incorrect Et CO2/Fi CO2 value may impair clinical decision making for both mechanically and spontaneously ventilated patients because of incorrect low CO2 values. GE Healthcare, LLC
Devices GE Healthcare, CARESCAPE Monitor B650. A multi-parameter patient monitor intended for use in multiple areas and intrahospital transport within a professional healthcare facility. Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report. Class II GE Healthcare has recently become aware of a potential safety issue due to possible sound loss associated with the CARESCAPE Monitor B650. When an external display is connected to the CARESCAPE Monitor B650 using a USB extender cable with an active USB hub, the system may experience a sound loss including alarm sounds from the patient monitor. This may occur if the external display is powered off and on during normal operation of the monitor. GE Healthcare, LLC
Devices Sarns D4 Aortic Arch Cannulae 6.0mm, 7mm & 8mm angled and straight tip with or without side holes and/or luer Product Usage: The Sarns Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. Part No. 165269, Lot #: 0649648, 0652316, 0653402, 0659824, 0678725, 0682564; Part No. 9482, Lot #: 0653227, 0656440, 0673777; Part No. 4344, Lot #: 0645166, 0653856, 0673024; Part No. 9485, Lot #: 654068; Part No. 9486, Lot #: 649867; Part No. 4400, Lot #: 0650491, 0659436, 0669133, 0674461; Part No.  ...
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Class II During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications Terumo Cardiovascular Systems Corporation
Devices Sarns Flexible Aortic Arch Cannula 8.0mm with luer, 3/8" connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. , Part No. 144936, Lot #: 653821 Class II During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications Terumo Cardiovascular Systems Corporation
Devices Sarns Malleable Dual-stage Venous Return Cannulae 28/38, 32/40 & 34/46 Fr with 1/2" connector with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava. Part No. 4934, Lot #: 0655207, 0657317, 0666535, 0682313, 0697852; Part No. 4934X, Lot #: 0659445, 0696672; Part No. 4935, Lot #: 0655206, 0656923, 0682315, 0685669, 0696718; Part No. 4936, Lot #: 0655292, 0665320, 0684443, 0684444, 0687492, 690459R & Part No. 4936X, Lot #: 0656438, 0661606, 683308R. Class II During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications Terumo Cardiovascular Systems Corporation
Devices Sarns Malleable Venous Return Cannulae 24, 28, 30, 32, 34, 36 & 40 Fr single stage with 3/8" & 1/2 flare with or without Xcoating Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava. Part No. 4881, Lot #: 0646527, 0652247, 0655237, 0657761, 0659431, 0663547, 0666625, 0674022, 0676975, 0678722, 0681793, 0693318, 0695683, 0697379; Part No. 4881X, Lot #: 684032; Part No. 4882, Lot #: 0646526, 0649165, 0650782, 0653857, 0657248, 0662811, 0668349, 0673863, 0676584, 0678953, 0682571, 0683601, 683601R; Part No. 4882X, Lot #: 0651693, 0656946,  ...
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Class II During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications Terumo Cardiovascular Systems Corporation
Devices Sarns Soft-arc Aortic Cannula 8.0mm curved tip, suture flange, 3/8" flare Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. Part No. 16094, Lot #: 655235 Class II During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications Terumo Cardiovascular Systems Corporation
Devices Sarns Soft-Flow Extended Aortic Cannulae 7.0mm & 8.0mm with or without luer & Xcoating, Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. Part No. 4948, Lot #: 0646471, 0652314, 0652909, 0656645, 0658692, 0662071, 0666665, 0669799, 0672089, 0675750, 0676585, 0678728, 0681792, 0684780, 0685667, 0688001, 0691202, 0693823, 0694711, 0696205, 0698300, 0708186, 0708766, 0710058, 0711914, 0714958, 0716134, 0717932, 0719278, 0721688, 694711R, 696201R; Part No. 4949, Lot #: 0646532, 0650731, 0651656, 0652458, 0655167, 0659823, 0661134, 0666626,  ...
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Class II During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications Terumo Cardiovascular Systems Corporation
Devices Sarns Two-stage Venous Return Cannulae 32/40 & 36/51 Fr with 1/2" & 3/8" flare or connector Product Usage: The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava. Part No. 4442, Lot #:, 0646528, 0649147, 0649840, 0654076, 0662223, 0678729; Part No. 14992, Lot #: 0646475, 0649160, 0655317, 0659466, 0666649, 0672081, 0675675, 0681806, 0686885; Part No. 4443, Lot #: 0649883, 0660672 & Part No. 15949, Lot #: 0646530, 0661896, 0667259, 0674784, 0683631. Class II During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications Terumo Cardiovascular Systems Corporation
Devices Sarns Venoatrial Cannulae 36/46 Fr with 1/2" flare or connector Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. The Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava. Part No. 4440, Lot #: 0646496, 0650492, 0659856, 0666657, 0674751, 0677190, 0686887, 0690546; Part No. 164525, Lot #: 0646401, 0652209, 0656640, 0662516, 0674459, 0678212 Class II During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications Terumo Cardiovascular Systems Corporation
Devices Terumo Dual-stage Venous Return Cannulae 28/38, 29/37, 32/40, 34/46, 36/46 & 36/51 Fr with 1/2" flare or connector Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava Part No. 813580, Lot #: AM004245, AM006060, AM016524; Part No. 813579,  ...
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Class II During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications Terumo Cardiovascular Systems Corporation
Devices Terumo TenderFlow Pediatric Venous Cannulae, 8, 10, 12, 14, 16, 18, 20, 22 & 24 Fr angled & straight tip, 1/4" & 3/8" flare, Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava Part No. 813542, Lot #: AM000378; Part No. 813541, Lot #: AM002689; Part No. 813544, Lot #: AM006016, AM017817; Part No. 813546, Lot #: AM002709, AM006018, AM006048, AM017262; Part No. 813545, Lot #: AM002705, AM006046, AM007636; Part No. 813548, Lot #: AM002707, AM006050, AM017681; Part No. 813547, Lot #: AM002697,  ...
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Class II During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications Terumo Cardiovascular Systems Corporation
Devices Terumo Three-stage Venous Return Cannulae 28 Fr with 3/8" flare, 30 Fr with 3/8" connector and 30 Fr with 3/8" flare. Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava. 28 Fr with 3/8" flare , Part No., 816460, Lot #:, 0645280, 0649157, 0654734, 0666686, 0674810, 0678724, 0682221, 0684790, 0698319, 0698910; 30 Fr with 3/8" connector , Part No., 820732, Lot #:, 646450 & 30 Fr with 3/8" flare , Part No., 820731, Lot #:, 0689843, 0698323 Class II During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications Terumo Cardiovascular Systems Corporation
Devices Sarns Soft-Flow Aortic Cannulae 6.0mm, 7mm & 8mm angled and straight tip, suture bulb with or without Luer and/or Xcoating Product Usage: The Aortic Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. Part No. 7071, Lot #: 0658575, 0662312, 0666660, 0670324, 0670948, 0682566, 0686889, 0689725, 0695466, 0702123, 689725R; Part No. 7072, Lot #: 0658572, 0662311, 0670325, 0686126, 0687466, 0694421, 0702124, 694421R, 694445R; Part No. 7072X, Lot #: 0662871, 662871R, 684785R; Part No. 7080, Lot #: 0661085, 0670671, 0675676, 0687168, 0694423, 0696700, 0702127,  ...
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Class II During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications Terumo Cardiovascular Systems Corporation
Devices CPB Catheter Kit Product Usage: Venous Return Cannula is indicated for venous drainage during cardiopulmonary bypass surgery for dual cannulation of the superior and inferior vena cava. Part No. 80003-02, Lot #: PG11, QC11, QL09 & Part No. 80002-03, Lot #: PG11, QL09 Class II During an in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of loose fiber particulate that exceeded finished product specifications Terumo Cardiovascular Systems Corporation
Devices RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (750 Tests) Part number: 10491449; RAPIDPoint 500 Measurement Cartridge Lactate (400 Tests) Part Number: 10491448 RAPIDPoint 500 Measurement Cartridge Lactate (250 Tests) Part Number: 10491447 RAPIDPoint 500 Measurement Cartridge Lactate (100 Tests) Part Number:10844813 Serial Numbers: 2334500011 through 2412705915 Class II RAPIDPoint 500 Measurement Cartridges may have an error code one or more electrolyte parameters (e.g., Na+, Ca++, K+, Cl-) Siemens Healthcare Diagnostics Inc
Devices RECLAIM® TAPER PROTECTOR SLEEVE To ensure the locking taper surface of the Distal Stem is protected during proximal preparation. Product #297500110; Lot #: 126559, 126569, 181990, 181995, 224156, 231487, 240683, 260366, 260370, 272820, 272827, 272831 & 272836. Class II DePuy Orthopaedics, Inc. is issuing a voluntary device correction of all lots of the Reclaim Taper Sleeve Protector component because the product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming. DePuy Orthopaedics, Inc.
Devices RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation. Product # 197714190; Lot # 107342, 107343, 107346, 107347, 138357, 138358, 138359, 138360, 138361, 138362, 138363, 163354, 163356, 163357, 190780, 190783, 190784, 211757, 211758, 225886, 225887, 228150, 228153, 231204, 235931, 235932, 235935, 246196, 246197, 251519, 251520, 254838, 254839, 264816, 264817, 282507, 282509, 282511, 282512, 288712, 288713, 288714, 288715, 288716 &  ...
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Class II DePuy Orthopaedics, Inc. is issuing a voluntary device correction of all lots of the Reclaim Taper Sleeve Protector component because the product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming. DePuy Orthopaedics, Inc.
Devices RECLAIM DISTAL TAPERED Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation. Product # 197614140; Lot # 107310, 107311, 107313, 107314, 107315, 136244, 136247, 136251, 136252, 136256, 136257, 136262, 136268, 136271, 136276, 136286, 196221, 196222, 196225, 225871, 225872, 225873, 228185, 228187, 228188, 235886, 235887, 240634, 240635, 246147, 246179, 254812, 254814, 260373, 260374, 264629, 264630, 281910, 281911, 281912, 281915, 288356, 288359, 288361, 288363,  ...
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Class II DePuy Orthopaedics, Inc. is issuing a voluntary device correction of all lots of the Reclaim Taper Sleeve Protector component because the product can be difficult to remove from the Distal Stem both out of the package and after proximal reaming. DePuy Orthopaedics, Inc.
Devices Synthes Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System). Orthopedic surgical instrument. part no. 03.111.600, lot no. 10-5147, and part no. 03.111.601, lot no. 10-5147 Class II The Guide Blocks for the 2 Column Plate 6 Hole Head (Volar Distal Radius Plate System) were found to be labeled incorrectly. Part no. 03.111.600 (Right) was found in the package labeled part no. 03.111.601 (Left). The laser etching denoting the orientation on the part is correct. Synthes, Inc.
Drugs DENBLAN Anticavity Fluoride Toothpaste, Whitening formula, sodium monofluorophosphate 0.76%, 2.6 oz/75 mL tube, Laboratories Darphin, Dist, Paris France All lot codes and shipment dates are being recalled. 2.6oz/75ml. in a light green carton, UPC: 8-82381-07901-7 Code: D079-01-1000 Class III Stability Data Does Not Support Expiry Estee Lauder Inc
Biologics Red Blood Cells Leukocytes Reduced Irradiated W200214020078; Class III Blood product, which was labeled with an incorrect expiration date, was distributed. American National Red Cross SW Region - HT
Drugs Levofloxacin 750 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #29184, Discard After 05/28/14 Rx 29184 Exp 5/28/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Vancomycin 750 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28289, Discard After 02/5/14; Rx # 29189, Discard After 05/23/14 Rx # 28289, Exp 02/5/14; Rx # 29189, Exp 05/23/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Pfizerpen (penicillin G) 24 MU/300 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29183, Discard After 05/21/14 Rx 29183 Exp, 5/21/2014 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Desferal 2.5 gm/14 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28314, Discard After 05/22/14 Rx 28314 Exp 5/22/2014 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Cefepime 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28288, Discard After 02/4/14; Rx # 29176, Discard After 05/21/14; Rx # 28829, Discard After 05/17/14 Rx # 28288, Exp 02/4/14; Rx # 29176, Exp 05/21/14; Rx # 28829, Exp 05/17/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Ceftriaxone 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, RX # 29038, Discard After 05/05/14, & 05/20/14; RX # 29204, Discard After 05/23/14; RX # 29161, Discard After 05/19/14 Rx # 29039, Exp 05/05/14 & 05/20/14; Rx # 29204, Exp 05/23/14; Rx # 29161, Exp 05/19/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Cubicin 486 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, RX # 29038, Discard After 05/20/2014 Rx # 29038, Exp 05/20/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Invanz (ertapenem)1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29157, Discard After 05/19/14; Rx # 29097, Discard After 05/20/14 Rx # 29157, Exp 5/19/14; Rx # 29097, Exp 5/20/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Meropenem 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29087, Discard After 05/28/14 Rx # 29087 Exp. 5/28/2014 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Nafcillin 12 gm/300 mL, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29162, Discard After 05/21/14 Rx 29162 Exp. 5/21/2014 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Unasyn (ampicillin/sulbactam) 1.5 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29082, Discard After 05/19/14 Rx # 29082 Exp. 5/19/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Desferal 2 gm/8 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 27767, Discard After 05/23/14 Rx # 27767, Exp 05/23/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Impipenem/Cilastin (Primaxin) 500 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx #28694, Discard After 05/22/14 Rx #28694, Exp 05/22/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Cefazolin 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28837, Discard After 04/11/14 Rx # 28837, Exp 04/11/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Cubicin 444 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29114, Discard After 05/13/14 Rx # 29114, Exp 05/13/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Normal Saline 10 mL/10 mL Syringe, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, Rx # 28839, Discard After 05/5/15; Rx # 29163, Discard After 05/8/15 Rx # 28839, Exp 05/5/15; Rx # 29136, Exp 05/8/15 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Ambisome 285 mg/250 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28300, Discard After 02/7/14 Rx # 28300, Exp 02/7/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs ANA Kit, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28838, Discard After 03/4/15 Rx # 28838, Exp 03/4/15 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Tobramycin 300 mg/7.5 mL Syringe (for Neb), Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28503, Discard After 02/27/14 Rx # 28503, Exp 02/27/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Vancomycin 1 gm/100 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29186, Discard After 05/22/14; Rx # 29010, Discard After 05/22/14 Rx # 29186, Exp 05/22/14; Rx # 29010, Exp 05/22/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Vancomycin 1.25 gm/250 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29140, Discard After 05/23/14 Rx # 29140, Exp 05/23/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Vancomycin 750 mg/150mL D5W,Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28878, Discard After 05/16/14 Rx # 28878, Exp 05/16/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Vancomycin 1.25 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29185, Discard After 05/23/14 Rx # 29185, Exp 05/23/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Cubicin 543 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29175, Discard After 05/21/14; Rx # 28830, Discard After 05/17/14 Rx # 29175, Exp 05/21/14; Rx # 28830, Exp 05/17/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Cubicin 600 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29096, Discard After 05/20/14 Rx # 29096, Exp 05/20/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Cubicin 700 mg/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29083, Discard After 05/21/14 Rx # 29083, Exp 05/21/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Cefepime 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29011, Discard After 05/21/14, Rx # 29141, Discard After 05/22/14, Rx # 29171, Discard After 05/20/14 Rx # 29011, Exp 05/21/14; Rx # 29141, Exp 05/22/14; Rx # 29171, Exp 05/20/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Ceftriaxone 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29150, Discard After 05/17/14 Rx # 29150, Exp 05/17/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Cefepime 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 28879, Discard After 05/21/14 Rx # 28879, Exp 05/21/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Drugs Ceftriaxone 1 gm/50 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Ocala, FL 34471-5138, For Parenteral Use Only, Rx # 29190, Discard After 05/23/14, Rx # 29068, Exp 05/18/14 Rx # 29190, Exp 05/23/14; Rx # 29068, Exp 05/18/14 Class II Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Franck's Lab Inc dba Trinity Care Solutions
Biologics Red Blood Cells Leukocytes Reduced Irradiated W230813623755; Class II Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed. Coastal Bend Blood Center
Food WEGMANS ICE in plastic bags; NET WT. 7 LBS (UPC 77890 29197) and NET WT 18 LBS (UPC 77890 29200) --- WEGMANS FOOD MARKETS INC. ROCHESTER, NEW YORK All codes sold between 1/1/2014 and 6/10/2014 Class II Product may contain metal pieces from a broken part in the ice machine. Wegmans Food Markets, Inc.
Biologics Red Blood Cells Leukocytes Reduced W290614053856; Class III Blood product, which did not meet the acceptable product specifications, was distributed. Penrose-St Francis Health Services Blood Bank
Biologics Platelets Pheresis Leukocytes Reduced W065614021981; Class II Blood product, which did not meet the acceptable product specification, was distributed. Bergen Comm Reg Blood Center
Biologics Platelets Pheresis Leukocytes Reduced W398514024761S; Class II Blood product, in which quality control on a platelet apheresis product was found to be unacceptable, was distributed. Community Blood Center of Carolinas
Biologics Platelets Pheresis Leukocytes Reduced W120614005600; W120614005600; Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Michigan Blood
Devices AGFA Digital Radiography X-Ray system DX-D 100 Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton including skull, spinal column and extremities: chest, abdomen, and other body parts. Agfa's DX-D 100 is not indicated for use in mammography. Serial # A5410000053, A5410000054, A5410000067, A5410000068, A5410000069, A5410000070, A5410000072, A5410000073, A5411000315, A5411000331, A5411000332, A5411000141, A5411000144, A5411000038, A5411000069, A5411000133, A5411000175, A5411000119, A5411000123, A5411000333, A5411000334, A5410000038, A5411000019, A5411000047, A5411000048, A5411000053, A5410000041, A5410000042, A5410000046, A5410000016, A5410000039, A5410000021, A5410000023, A5411000074, A5411000080, A5411000024, A5411000184, A5411000193, A5411000196, A5410000100, A5410000114, A5410000115, A5410000116, A5410000117, A5411000342, A5411000343, A5411000344, A5411000366,  ...
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Class II When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings. AGFA Corp.
Devices GE Healthcare, CARESCAPE Monitor B850, B650 or B450. Patient Monitor. Excessive data in the Code Information for this product has caused issues with the CSV download function. The complete list of Code Information can be found at the Addendum to Enforcement Report. Class II GE Healthcare has recently become aware of a potential safety issue due to partial loss of monitoring with the CARESCAPE Monitor B850, B650 or B450. When connecting the PDM (Patient Data Module) to the CARESCAPE B850, B650 or B450 monitor with software version 2 the PDM may not start communicating to the monitor and loss of the PDM parameters could occur. GE Healthcare, LLC
Devices EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract. Model: EG-3630U A01013 E010080 E110111 E110159 E110236 A01017 E010082 E110116 E110161 E110237 A01022 E010084 E110118 E110167 E110239 A01025 E010092 E110120 E110169 E110240 A01026 E010093 E110132 E110172 E110256 A01028 E010094 E110134 E110177 E110277 A01029 E010095 E110135 E110179 E110278 A01031 E010096 E110138 E110182 E110282 A01033 E01037 E110139 E110187 E110283 A01036 E01038 E110140  ...
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Class II Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope. This may result in patient injury if the Instruction for Use is not followed carefully by the user. Pentax Medical Company
Food YES Raspberry Lemonade Sorbetto No code Class III Mislabeling of product as "Organic" Dolci Gelati LLC.
Food YES Green Tea Gelato no code Class III Mislabeling of product as "Organic" Dolci Gelati LLC.
Food YES Sea Salt Caramel Gelato No code Class III Mislabeling of product as "Organic" Dolci Gelati LLC.
Food YES Peanut Butter Cup Gelato no code Class III Mislabeling of product as "Organic" Dolci Gelati LLC.
Food YES Mocha Gelato no code Class III Mislabeling of product as "Organic" Dolci Gelati LLC.
Food YES Mango Agave Sorbetto no code Class III Mislabeling of product as "Organic" Dolci Gelati LLC.
Food Country Life TARGET MINS CALCIUM MAGNESIUM With Vitamin D3 Complex, WILD BLUEBERRY FLAVOR, LIQUID Dietary Supplement, 16 FL. OZ. (1 PINT) (472 mL), Product No. 2523, Bar Code 015794025238, and 32 FL. OZ. (1 QT) (944 mL), Product No. 2522, Bar code 015794025221 --- Manufactured for Country Life, LLC 180 Vanderbilt Motor Parkway, Hauppauge, NY 11788 Code 2523: Lot 1112H6-G16 (16 fl. oz), Code 2522: Lot 1112H6-G32 (32 fl. oz.) Class II The affected lots do not meet quality standards due to insoluble particulates. Country Life
Devices MK5 NX Controller--Wheelchair controller P/N 1143839 Class II M41 Powered Wheelchairs received through Invacare Service Parts (ISP) have controllers that were programmed in a way this is not aligned to standard factory settings. The controller during different settings such as max forward speed, max forward acceleration, max reverse speed and max turning speed can result in momentary loss of control. Invacare Corporation
Devices Disposable StrykeFlow Tip, Stryker Disposable Suction/I irrigator Tip; Sterile, Rx only, Latex Free. Stryker Suction Irrigation system, used to provide a clean and clear operative site through the evacuation and aspiration of irrigant solution. P/N 0250070505; Lot numbers: 14021FG2, 13337FG2, 13343FG2, 13347FG2, 14007FG2, 14016FG2. Class II Internal review found that six lots of Disposable StrykeFlow Tips were shipped with a potentially deformed blister pouch which could impact sterility of the product. Stryker Endoscopy
Food Fat free cottage cheese sold under the Knudsen or Kraft brand and packaged in a plastic container with a net weight of 16 oz. (1 lb.) 453 g, a plastic container with a net weight of 24 oz. (1.5 lb.) 680 g, or a plastic container with a net weight of 32 oz. (2 lb.) 907 g. Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014 Class II Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness. Kraft Foods Group
Food Low fat cottage cheese, 2% milkfat, sold under the Breakstone's brand, Daily Chef brand, Knudsen brand, or Kraft brand packaged in a tray of 4 plastic containers each with a net weight of 4 oz. (113 g), a tray of 8 plastic containers each with a net weight of 4 oz. (113 g), a plastic container with a net weight of 8 oz. (227 g), a plastic container with a net weight of 16 oz. (1 lb.) 453 g, a plastic container with a net weight of 24 oz. (1.5 lb.) 680 g, a plastic container with a net weight of 32 oz. (2 lb.) 907 g, or a 3 lb. plastic container with a net weight of 48 oz. (3 lb.) 1.36 kg. Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014 Class II Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness. Kraft Foods Group
Food Cottage cheese, 4% milkfat, sold under the Daily Chef, Knudsen, or Kraft brand and packaged in a plastic container with a net weight of 8 oz. (227 g), a plastic container with a net weight of 16 oz. (1 lb.) 453 g, a plastic container with a net weight of 24 oz. (1.5 lb.) 680 g, a plastic container with a new weight of 32 oz. (2 lb.) 907 g, or a plastic container with a net weight of 5 lb. (2.27 kg). Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014 Class II Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness. Kraft Foods Group
Food Cottage Doubles - cottage cheese, 2% milkfat, with peach topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g). Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014 Class II Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness. Kraft Foods Group
Food Cottage Doubles - cottage cheese, 2% milkfat, with strawberry topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g). Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014 Class II Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness. Kraft Foods Group
Food Cottage Doubles - cottage cheese, 2% milkfat, with pineapple topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g). Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014 Class II Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness. Kraft Foods Group
Food Cottage Doubles - cottage cheese, 2% milkfat, with blueberry topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g). Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014 Class II Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness. Kraft Foods Group
Food Cottage Doubles - cottage cheese, 2% milkfat, with raspberry topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g). Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014 Class II Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness. Kraft Foods Group
Food Cottage Doubles - cottage cheese, 2% milkfat, with mango topping sold under the Knudsen brand and packaged in a plastic container with a net weight of 3.9 oz. (110 g). Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014 Class II Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness. Kraft Foods Group
Food Cottage cheese, 2% milkfat, with pineapple sold under the Breakstone's brand or Knudsen brand and packaged in a tray of 4 plastic containers each with a net weight of 4 oz. (113 g). Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014 Class II Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness. Kraft Foods Group
Food Low fat cottage cheese, 1.5% milkfat, with pineapple sold under the Knudsen brand packaged in plastic containers with a net weight of 16 oz. (1 lb.) 453 g. Plant Code: 06-245; Code Dates: 09 MAY 2014 through 23 JUL 2014 Class II Kraft Foods is voluntarily recalling 18 SKUs of Knudsen Cottage Cheese, nine SKUs of Breakstone's Cottage Cheese, five SKUs of Simply Kraft Cottage Cheese and two SKUs of Daily Chef Cottage Cheese produced at our Tulare, CA manufacturing facility. Some ingredients used in these products were not stored in accordance with Kraft's temperature standards. While unlikely, this could create conditions that could lead to food borne illness. Kraft Foods Group
Devices Hemochron Jr. Whole Blood Microcoagulation System APTT Cuvette. For in vitro diagnostic coagulation test. Catalog number J103. Lot Number A4JCA001 Class II Test results may be erroneously elevated or report an out-of-range high (OOR-H) error code. ITC-Nexus Dx
Devices Solanas 2.1mm FIXED DEPTH DRILL, 10mm, Part No. 63928-10. Component of the SOLANAS III Posterior Stabilization System, a spinal fixation system intended to improve stability of the cervical and thoracolumbar area of the spine (C1-T3). Lot No. 7117902 Class II Alphatec Spine is recalling the 2.1mm Fixed Depth Drill 10mm because they received a report that the instrument malfunctioned and golden stop slid from its fixed position during use. Alphatec Spine, Inc.
Food Item: 4815 Land O'Lakes, Extra Melt American White, Pasteurized Process American Cheese, Net WT 5 lbs (2.26 KG) Lot#: 31507365 Class II Land O'Lakes is recalling certain cheese products due to potential contamination with large pieces of plastic in the product. Land O' Lakes, Inc
Food Item: 48775 Land O'Lakes, Golden Velvet Pasteurized Process Cheese Spread - Yellow, NET WT 5 LBS (2.26 KG) Lot#: 31508146 & 31507367 Class II Land O'Lakes is recalling certain cheese products due to potential contamination with large pieces of plastic in the product. Land O' Lakes, Inc
Food Item: 48770 Land O'Lakes, Pasteurized Process Cheese Product, Yellow, NET WT 5 LBS (2.27 KG). Lot#: 31508147 and 31510762 Class II Land O'Lakes is recalling certain cheese products due to potential contamination with large pieces of plastic in the product. Land O' Lakes, Inc
Food Item: 48135 Land O'Lakes, Premium Deli Cheese, American, 5 lbs (2.27 KG) Lot#: 31510765 Class II Land O'Lakes is recalling certain cheese products due to potential contamination with large pieces of plastic in the product. Land O' Lakes, Inc
Food UltraBalance Protein Powder, Net Wt. 14.8 oz (420g) Lot # 0712072, 0213041, 0813013, 0913002, 0214064 Class II Metagenics is recalling UltraBalance Protein powder because it may contain undeclared soy. Metagenics, Inc.
Food BBQ Pull-A-Part Bread (Brands: Sunbeam (UPC 0 77633 05303 1), Bunny (UPC 0 71025 01500 3), Flowers [Foodservice] (UPC 0 72250 01866 1) and Ingles (UPC 0 86854 01543 8), 16oz clear flexible plastic bags, Distributed by Flowers Bakeries, LLC, Thomasville, GA 31757. Sell by date codes: JUL 3 180 172 Class I Undeclared allergen: Milk; Products made from margarine did not declare milk as part of the ingredient. Flowers Foods
Devices Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use. Lot numbers: 090213, 090913, 021714, 022414, 042814, 051914, 052614 Class II The case label correctly states partial rebreather but the insert label incorrectly states non-rebreather. Salter Labs
Devices Pad-Pak and Pedi-Pak accessories for the HeartSine Samaritan PAD 300P and 350P device (SAM 300P and 350P) Automate External Defibrillator electrode supplies. The Pedi-Pak is specifically designed for use with the HeartSine Samaritan PAD 300P and 350P device. It contains defibrillator electrodes in a sealed foil pouch and a battery pack in a sealed plastic housing. Pad-Pak 01 & Pad-Pak 02 · Adult Lot Numbers: A1785 to A1805 · Pediatric Lot Numbers: P433 to P445. Class II HeartSine Technologies, Ltd. initiated a voluntary recall of its Pad-Pak and Pedi-Pak user-replaceable sub-assemblies for the HeartSine family of automated external defibrillators because a small number of sealed foil pouches containing the electrodes were found to be difficult to open, resulting in potential delay in therapy. Heartsine Technologies, Limited
Veterinary KOXY KRUMBLES MEDICATED calf pellet/crumble feed; 50 lb bag; Active Drug Ingredient Amprolium 1.25%; Manufactured By: CHS Inc. Sioux Falls, SD 57107 Manufacturer's Lot Code: M927140 Product Code: 2730 Class II PGG/HSC Feed Co., LLC is recalling Koxy Krumbles, an amprolium medicated calf pellet/crumble, due to 70% of declared amprolium. PGG/HSC Feed Co. LLC
Devices Insite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use. Catalog number RD471-60K: Lot numbers: RD4710111, Exp Jan 2012; RD4710411, Exp. Apr 2012; RD4711013, Exp Oct 2014. Class II Product was distributed without 510(k) approval. Biogenex Laboratories, Inc.
Biologics Reagent Red Blood Cells 842201100 Class III Misbranded reagent red blood cells were distributed. Bio-Rad Medical Diagnostics GmbH
Devices Zoll Circulation LifeBand Single Pack (accessory), and Nickel-metal hydride (NIMH) Battery. The LifeBand is a chest compression assembly that consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. The AutoPulse Battery is a removable component that supplies power for the AutoPulse operation. Used in the AutoPulse Resuscitation System Model 100, for chest compressions as an adjunct to manual CPR. LifeBand Single Pack: product code 8700-03, lot 41515; Nickel-Metal hyride battery: product code 8700-0702-03: serial numbers: 03690,03695,03696,03700,03701,03702,03706,03707,03708,03709,03710, 03711,03715,03717,03718,03720,03721,03726,03727,03728,03730,03732, 03733,03734,03736,03738,03742,03743,03745,03749,03750,03758,03768, 03770,03772,03773,03778,03779,03781,03782,03783,03786,03788,03797, 03799,03805,03806,03809,03863,03866,03867,03869,03871,03874,03875, 03880,03881,03882,03883,03888,03889,03890,03893,03894,03895,03896, 03899,03901,03906,03910,03916,03926,03943,04064,04067,04100,04119, 04133,04193,04223,04233,04301,04303,04304,04337,04364,04397,04399, 04400,04405,04406,04408,04409,04410,04411,04415,04417,04418,04419, 04420,04421,04422,04423,04433,04442,04468,04470,04478,04482,04483, 04510,04511,04514,04585,04586,04587,04588,04589,04591,04593,04594, 04595,04596,04598,04599,04600,04603,04607,04608,04610,04611,04612, 04617,04619,04635,04641,04662,04674,04675,04676,04678,04679,04682, 04704,04705,04712,04718,04744,04762,04763,04773,04774,04777,04780, 04782,04785,04786,04789,04795,04828,04838. Class III Typographical error in the Japanese legal label of the AutoPulse Resuscitation System Model 100. The label is specific to the Japanese version of the product. Zoll Circulation, Inc.
Drugs Clonidine HCl Injection, 1000 mcg/10 mL (100 mcg/mL),10 mL Single Dose Vial, Rx only, Manufactured for: X-Gen Pharmaceuticals Inc., Big Flats, NY 14814, NDC 39822-2000-1. Lot: PLNB1412, Exp 12/15 Class III Labeling: Label Error On Declared Strength: The side label description incorrectly states "Each mL contains 500 mcg Clonidine Hydrochloride" instead of stating "Each mL contains 100 mcg Clonidine Hydrochloride". X-Gen Pharmaceuticals Inc.
Devices Hudson RCI, Breathing Circuit, Adult, Single Limb w/Heated Wire, [Respiratory Gas Humidifier, (Direct Patient Interface)]. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier. Catalog Number: 780-96, Lot numbers: 02L1300073 & 02A140133. Class II The temperature probe does not properly connect to the temperature port. Teleflex Medical
Devices Hudson RCI, Breathing Circuit, Adult Single Limb (W/Connector, Adaptor, Y Piece), Rx Only, Single Patient Use. The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier. Catalog Number: 1696, Lot numbers: 02K1301986, 02L1300010, 02L1300037, 02L1301081, 02L1301783, 02M1300190, 02M1300236, 02A1400518 02A1401286, 02A1402358, 02B1400178, 02B1400715 & 02B1401320. Class II The temperature probe does not properly connect to the temperature port. Teleflex Medical
Devices QLAB 10 Core Module PN 453561704771. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products. 795041 All serial numbers. Class II Philips Healthcare has discovered a problem in the Philips Ultrasound QLAB version 10.0 and 10.1 that could result in the erroneous calculation of Ejection Fraction (EF) from the results of a2DQ and aCMQ patient exams. Philips Ultrasound, Inc.
Devices QLAB 10.1 Core Module PN 453561728001. QLAB Quantification Software is a software application package designed to view and quantify image data acquired on Philips Medical Systems ultrasound products. 795041 All serial numbers. Class II Philips Healthcare has discovered a problem in the Philips Ultrasound QLAB version 10.0 and 10.1 that could result in the erroneous calculation of Ejection Fraction (EF) from the results of a2DQ and aCMQ patient exams. Philips Ultrasound, Inc.
Devices Siemens syngo Imaging XS, version VA70A or higher 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 post processing applications. model number: 10496279 Class II Siemens has become aware of the potential malfunction when using syngo Imaging XS, version VA70A or higher. In some cases a miscalculation may occur for the grey scale values in the functions Region of Interest, Pixel Lens, Edge enhancement and Histograms. This potential malfunction may occur for images with a pixel depth greater than 12 bit. All values calculated for images with a pixel depth less than or equal to 12 bit are correct. Siemens Medical Solutions USA, Inc
Devices Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter. Model 0218TA and 0218TB. Manufacturing Lot Numbers: 12031275 and 12031242. EXP.: 02/2017. Batches: 12031526, 12031249, 12031527, 12031248, 12041183, 12041186, 12031244, 12031461, 12031460, 12021404, 12031462, 12031245, 12021405, 12031405, 12031246, 12021401, 12041344, 12031237, 12031241, 12021403, 12041345, 12041184, 12031497, 12031240, 12021194, 12031524, 12031480, 12041181, 12031275, 12031242, 12021450, 12021449, 12041185, 12031525, 12031247, 12021402, 12021448. Class II Perouse Medical in France initiated a voluntary recall of certain batches of Perouse FLAMINGO Inflations Devices due to a potential water-tightness default. The potential default could cause an air entry when the plunger is positioned around 20 mL. Perouse Medical
Drugs Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540. Lot # DM1316; Exp. 05/16 Lot # DM1318; Exp. 05/16 Class III Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing. Sandoz Inc
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