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U.S. Department of Health and Human Services

Enforcement Report - Week of March 19, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Cryoprecipitated AHF 011FL48039, 011GG54687, 011GG54691, 011GG54692, 011GG54694, 011GN89879, 011GN89897, 011GN89906, 011GN89908, 011GR84727, 011FW38211, 011FW38226, 011FW38282, 011FW38285, 011FW38286, 011FW38287, 011FW38296, 011FW38297, 011FW38298, 011FW38300, 011FW38301, 011FW38302, 011GJ78797, 011GJ78800, 011GJ78801, 011GJ78803, 011GJ78809, 011GJ78810, 011GJ78813, 011FL46117, 011FL46121, 011FL46125, 011FL46129, 011FL46130, 011FL46131, 011FL46138, 011FL46140, 011FL46141, 011FL46220, 011FL46221, 011FL46222, 011FL46224, 011FL46225, 011FL46226, 011FL46229, 011FL46606, 011FL46610, 011FL47248, 011FL47267, 011FL47386,  ...
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Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 011FL47869, 011FL47960, 011FL47967, 011FL47988, 011FL48025, 011FL48035, 011FL48133, 011GG54687, 011GG54691, 011GG54692, 011GG54694, 011GN89880, 011GN89882, 011GN89884, 011GN89885, 011GN89892, 011GN89894, 011GN89897, 011GN89904, 011GN89905, 011GR84667, 011GR84699, 011GR84727, 011GR84734, 011GR84736, 011GR84990, 011GR84995, 011GR85007, 011GR85025, 011GR85073, 011GR85086, 011GR85087, 011FW38211, 011FW38226, 011FW38282, 011FW38287, 011FW38297, 011FW38300, 011FW38302, 011GJ78800, 011GJ78803, 011GS96842, 011GS96847, 011GS96848, 011GS96850, 011GS96855, 011GS96857, 011GS96859, 011GS96862, 011GS96865,  ...
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Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells 011GJ78797, 011GJ78801, 011GJ78809, 011FL46105, 011FL46106, 011FL46117, 011FL46121, 011FL46125, 011FL46129, 011FL46130, 011FL46131, 011FL46138, 011FL46140, 011FL46141, 011FW37216, 011FX11239, 011FX11241, 011FX11243, 011FX11246, 011FX11261, 011FX11264, 011FX11266, 011GG53993, 011GG53994, 011GG53996, 011GG54004, 011GG54007, 011GG54009, 011GG54689, 011GK98769, 011GK98771, 011GK98775, 011GK98780, 011GK98786, 011GK98789, 011GK98793, 011GK98795, 011GK98801, 011GK98803, 011GK98804, 011GW73737, 011GW73740, 011GW73741, 011GW73756, 011GW73758, 011GW73760, 011GW73762, 011GW73764, 011GW73874, 011GW73876,  ...
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Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced Irradiated 011GR85032, 011GS96849, 011FL46158, 011FL46165, 011FL46224, 011FL47267, 011FS50157, 011FS50180, 011FW36887, 011FW36917, 011FW37198, 011FX10078, 011FX10117, 011FX10936, 011FX11204, 011GG53991, 011GN89287, 011GN89290, 011GQ85634, 011FS48758, 011FS48999, 011FS49042, 011FT19301, 011FX09399, 011FY35028, 011GC80922, 011GG49902, 011GG49905, 011GG49908, 011GG49969, 011GG51266, 011GG51278, 011GK96463, 011GK96488, 011GN87808, 011GN87811, 011GQ82752, 011GR78760, 011FW32214, 011GG48696, 011GG49445, 011GQ79911, 011GR74757, 011GS90796, 011GS90801, 011GS91560, 011GY42344, 011GY42522, 011FW31345, 011GR73686,  ...
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Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American Red Cross Blood Services
Biologics Fresh Frozen Plasma 011FL46106, 011FL46162, 011FL46165, 011FS50153, 011FS50172, 011FS50174, 011FS50234, 011FS51022, 011FS51025, 011FS51030, 011FS51032, 011FS51035, 011FS51037, 011FS51038, 011FS51039, 011FS51040, 011FT19632, 011FT19788, 011FT19798, 011FT19800, 011FT19809, 011FW36893, 011FW36917, 011FX10112, 011FX10115, 011FX10118, 011GG54667, 011GG54668, 011GG54671, 011GK98044, 011GK98049, 011GK98053, 011GK98056, 011GK98058, 011GK98065, 011GK98066, 011GK98769, 011GK98771, 011GK98775, 011GK98776, 011GQ84443, 011GQ84448, 011GQ84449, 011GQ85033, 011GQ85629, 011GQ85630, 011GQ85632, 011GQ85634, 011GQ85636, 011GQ85639,  ...
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Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American Red Cross Blood Services
Biologics Plasma Frozen 011FL46149, 011FL46615, 011FL46617, 011FL46620, 011FL46622, 011FL46623, 011FW36922, 011FW37198, 011FW37201, 011FX10074, 011FX10083, 011GG52911, 011GQ84420, 011GQ84426, 011GQ84428, 011GR82779, 011GR82788, 011GR83783, 011GR83787, 011GR83791, 011GW73879, 011GW73883, 011GW73889, 011FJ13972, 011FS47824, 011FT18757, 011FT18759, 011FT18761, 011FT18913, 011FX08918, 011FX08923, 011FX08940, 011FX08942, 011FX08947, 011FX08970, 011FX09758, 011FX09759, 011FX09764, 011FZ71066, 011FZ71075, 011FZ71670, 011FZ71671, 011GC80825, 011GC80829, 011GC80838, 011GC80846, 011GC80874, 011GC80880, 011GC49898, 011GC49902,  ...
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Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American Red Cross Blood Services
Biologics Plasma Frozen Cryoprecipitate Reduced 011FS51244, 011FT20149, 011FT20164, 011FX10583, 011FX10930, 011FX10936, 011FX11045, 011FX11070, 011FX11077, 011FX11179, 011FX11600, 011FY36268, 011GK98780, 011GK98789, 011GK98795, 011GK98801, 011GK98803, 011GN89595, 011GN89599, 011GQ85065, 011GQ85533, 011GR83527, 011GR83530, 011GR83546, 011GR83549, 011GY44909, 011GY44911, 011GY44917, 011GY44925, 011KN17373, 011KN17730, 011KN17742, 011FS49047, 011FT18775, 011FT18780, 011FW34896, 011FW34908, 011FW34910, 011FW34953, 011FW34956, 011FY34686, 011FY34689, 011FY34690, 011FY34694, 011FY35713, 011FZ72442, 011FZ72527, 011GG49912, 011GG49913, 011GG49915,  ...
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Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells, Frozen 011GK94709 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. American Red Cross Blood Services
Biologics Platelets Pheresis Leukocytes Reduced 107252509 (2 units), 102977169 (2 units), 101897456 (2 units), 101885085 Class II Blood products, collected from a donor who was taking a medication containing aspirin at the time of donation, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 107215315 Class II Blood products, which were stored under unacceptable storage conditions, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells Leukocytes Reduced 242463929 Class II Blood products, which were stored under unacceptable storage conditions, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 104176388 (2 units) Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells Apheresis Leukocytes Reduced 300577901 (2 units), 305638451 (2 units), 305638461 (2 units), 305638469 (2 units), 305638471 (2 units), 309605582 (2 units) Class II Blood products, which were not appropriately tested for West Nile Virus (WNV), were distributed. Blood Systems, Inc.
Biologics Red Blood Cells Leukocytes Reduced 300577900, 300577903, 300577905, 300577906, 305638450, 305638452, 305638457, 305638459, 305638460, 305638465, 305638466, 305638468, 305639302, 305639303, 305639306, 305639311, 305639313, 305639317, 305639318, 305639319 Class II Blood products, which were not appropriately tested for West Nile Virus (WNV), were distributed. Blood Systems, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 104199421;104199421 Class III Blood components, processed from Whole Blood and refrigerated more than eight hours after collection, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells Leukocytes Reduced 104199423; Class III Blood components, processed from Whole Blood and refrigerated more than eight hours after collection, were distributed. Blood Systems, Inc.
Biologics Blood and Blood Products for Reprocessing 104192399 Class III Blood components, processed from Whole Blood and refrigerated more than eight hours after collection, were distributed. Blood Systems, Inc.
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W041008015909V, W041008017196X Class II Blood products, for which the irradiation was performed incorrectly, were distributed. Blood Systems, Inc.
Food Nicomex Camaron Entero Whole Shrimp Net Wt 1 oz (28.35 grams). Productos Mexicanos Distributed by Nicomex Inc. 88 First Street, Passaic, NJ 07055 Tel. (973) 815-2062. UPC 8 84678 10173 9. UPC 8 84678 10173 9. Class II Nicomex Inc. is recalling Camaron Entero for undeclared sulfites and Color Para Tamal for unapproved color based on NYSDAM Laboratory analysis. Nicomex Inc.
Food Nicomex Color Para Tamal Net Wt 1/8 oz (3.54gms) Productos Mexicanos Distributed by Nicomex Inc. 88 First Street, Passaic, NJ 07055 Tel. (973) 815-2062. UPC 8 84678 10369 6 Class II Nicomex Inc. is recalling Camaron Entero for undeclared sulfites and Color Para Tamal for unapproved color based on NYSDAM Laboratory analysis. Nicomex Inc.
Drugs BEST Slim, Dietary Supplement, 100% Natural Weight Loss Pill, 40 Pills per bottle, Distributed by CTV Best Group Inc., P.O. Box 956452, Duluth, GA 30095. All lots (lot 109400, Exp 12/31/2016) Class I Marketed without an Approved NDA/ANDA: Product contains an undeclared drug, sibutramine, making it an unapproved new drug. CTV Best Group
Devices 4040-2: Umbilical 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® device, 22g x 1½ needle, and Point-Lok® needle safety device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection. 2485103 2493959 2498064 2511207 2521581 2525780 2525781 2533316 2547272 2574207 2578556 2472508 2476319 2467728 2497730 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Smiths Medical ASD, Inc.
Devices 4042-2: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection. 2463876 2472511 2476324 2476325 2480609 2485108 2489875 2493965 2503422 2503423 2506814 2511211 2513709 2521588 2529536 2533320 2536817 2547283 2551262 2551263 2560919 2560920 2569052 2569053 2574217 2463876 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Smiths Medical ASD, Inc.
Devices 4043-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection. 2459798 2472512 2472513 2476329 2480613 2480614 2489880 2493968 2498070 2503427 2506816 2511212 2513711 2521591 2521592 2525786 2529541 2533323 2547290 2547291 2551266 2555870 2560932 2569056 2569057 2569058 2463882 2467732 2574219 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Smiths Medical ASD, Inc.
Devices 4043G-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® device and ice bag Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection. 2489881 2503429 2513713 2525788 2555872 2472514 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Smiths Medical ASD, Inc.
Devices 4043W-2: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® device, syringe tip cap and 6 mL Luer slip syringe Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection. 2485116 2489882 2498071 2503431 2506818 2511214 2521593 2533326 2542764 2547293 2555873 2560933 2569066 2578565 2459802 2472515 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Smiths Medical ASD, Inc.
Devices 4042LH: 3 mL Line Draw, Luer lock syringe (heparin concentration: 7 I.U. per mL)with Filter-Pro® device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection. 2459795 2476328 2503425 2521590 2529540 2533322 2551265 2560930 2569055 2574218 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Smiths Medical ASD, Inc.
Devices 4042E: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection. 2476326 2480611 2493966 2493967 2506812 2506813 2529537 2529539 2533321 2536818 2536820 2547286 2459794 2463880 2463881 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Smiths Medical ASD, Inc.
Devices 4043E: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® device (for sale in Europe only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection. 2476330 2476331 2485112 2485113 2485115 2493970 2493971 2493972 2506817 2511213 2525787 2529542 2536822 2538273 2542763 2459801 2467733 2467734 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Smiths Medical ASD, Inc.
Devices G1469J: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® device (for sale in Japan only) Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection. 2467804 2480661 2503528 2503529 2521653 2529597 2529598 2551329 2572218 2572220 2467805 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Smiths Medical ASD, Inc.
Devices G1725: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® device and 1 mL Line Draw Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® device Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection. 2530465 2530465 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Smiths Medical ASD, Inc.
Devices G1762: 3 mL Line Draw, Luer lock syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® device, syringe tip cap, and 5 mL Luer lock syringe Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection. 2483968 2492596 2496746 2500736 2505477 2514016 2524048 2529356 2536681 2541173 2554034 2475168 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Smiths Medical ASD, Inc.
Devices G1777: Umbilical (2) 3 mL Line Draw, Luer lock syringes (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® devices and (2) Needle-Pro® Devices with 22G x 1½needles Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection. 2491431 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Smiths Medical ASD, Inc.
Devices G2001: 3 mL Line Draw, Luer slip syringe (heparin concentration: 23.5 I.U. per mL) with Filter-Pro® device, Needle-Pro® Device and 23G x 1 needle Arterial Blood Sampling Line Draw Syringes are sterile, single-use devices, in-vitro diagnostic devices used for the drawing of arterial blood via an arterial line. The product is not for injection. 2548332 Class II issue with the plunger tip of the Portex® Arterial Blood Sampling Line Draw Syringes Smiths Medical ASD, Inc.
Devices GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 CARESCAPE Monitor B650 The CARESCAPE Monitor B650 is a multi-parameter patient monitor intended for use in multiple areas and intra-hospital transport within a professional healthcare facility. The CARESCAPE Monitor B650 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B650 is indicated for monitoring and recording of, and to generate alarms for, hemodynamic (including ECG, ST segment, arrhythmia detection, ECG diagnostic analysis and measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, cardiac output, temperature and mixed venous oxygen saturation), impedance respiration, airway gases (CO2, O2, N2O and anesthetic agents), spirometry, gas exchange, and neurophysiological (including electroencephalography, Entropy, Bispectral Index (BIS) and neuromuscular transmission(NMT) status. The CARESCAPE Monitor B650 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for remote viewing and to data management software devices via a network. The CARESCAPE Monitor B650 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. The CARESCAPE Monitor B650 is not intended for use during MRI. K092027 CARESCAPE Monitor B850 The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Temperature, Impedance Respiration and SvO2 (Mixed Venous Oxygen Saturation), Airway Gases (Fi/Et C02, 02, N20 and Anesthetic Agent), Spirometry, Gas Exchange (02 Consumption (VO2), C02 production (VCO2), energy expenditure (BE), and respiratory quotient (RQ)) and neurophysiological (including electroencephalography (EEG), Entropy, Bispectral Index (BIS) and Neuromuscular Transmission (NMT) Monitoring) status. The CARESCAPE Monitor B850 provides alarms, trends, snapshots and events, and calculations and can be connected to displays, printers and recording devices. The CARESCAPE Monitor B850 can be a stand-alone monitor or interfaced to other devices. It can also be connected to other monitors for bed to bed viewing and to data management software devices via a network. The CARESCAPE Monitor B850 is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility. In addition to the healthcare practitioner, the CARESCAPE Monitor B850 is designed to provide configuration and troubleshooting capabilities to qualified service personnel. The CARESCAPE Monitor B850 is not intended for use during MRI. K131414 CARESCAPE MONITOR B850 The CARESCAPE Monitor B850 is a multi-parameter high acuity patient monitor intended for use in multiple areas within a professional healthcare facility. The CARESCAPE Monitor B850 is intended for use on adult, pediatric, and neonatal patients and on one patient at a time. The CARESCAPE Monitor B850 system is indicated for monitoring of Hemodynamic (including ECG, ST Segment, Arrhythmia Detection, ECG Diagnostic Analysis and Measurement, Invasive Pressure, Noninvasive Blood Pressure, Pulse Oximetry, Cardiac Output, Thermodilution and pulse contour), Temperature, Mixed Venous Oxygen Saturation, and Central Venous Oxygen Saturation). Respiratory [Impedance Respiration, Airway Gases (C02, 02, N20 and Anesthetic Agents), Spirometry, Gas Exchange] and N Mfg Lot or Serial # SEW13380452HA SEW13380454HA SEW13380455HA SEW13380500HA SEW13380501HA SEW13380502HA SEW13380503HA SEW13380504HA SEW13380505HA SEW13380506HA SEW13380507HA SEW13380508HA SEW13380509HA SEW13380512HA SEW13380520HA SEW13380524HA SEW13380525HA SEW13380526HA SEW13380534HA SEW13380535HA SEW13380536HA SKA13130068GA SKA13130071GA SKA13130075GA SKA13130077GA SKA13130078GA SKA13130082GA SKA13130085GA SKA13140118GA SKA13370167GA SKA13370211GA SKA13370214GA SKA13370215GA SKA13370216GA SKA13370217GA SKA13370218GA SKA13370219GA SKA13370220GA SKA13370221GA SKA13370222GA SKA13370223GA SKA13370224GA SKA13370225GA SKA13370226GA SKA13370227GA  ...
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Class II GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE Monitor B850 and CARESCAPE Monitor B650. These issues include both NIBP (Non-Invasive Blood Pressure) and Bed to Bed Issues. GE Healthcare, LLC
Devices Navigator Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing. SGKIT (SGTRAY) Class II During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required. Biomet 3i, LLC
Devices Tapered Navigator Certain Surgical Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing. SGTIKIT (SGTTRAY) Class II During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required. Biomet 3i, LLC
Devices Contra-Angle Torque Driver Kit Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing. NCATDO aka CATD0 (PSDT1) Class II During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required. Biomet 3i, LLC
Devices Contra-Angle Torque Driver Kit For Certain Internal Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing. NCATD0C (PSDT1) Class II During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required. Biomet 3i, LLC
Devices Contra-Angle Torque Driver Kit For Certain and External Connection Product Usage: Molded plastic tray used in holding various dental instruments for autoclave processing. NPSDK0 aka PSKDO (PSKDT1)( Class II During recent revised sterilization validation testing, the included surgical trays did not meet the Sterility Assurance Level required. Biomet 3i, LLC
Drugs Dextrose* Vial In Sterile Water, 50%, 50 mL Single Dose Vial, Rx only, Specialty Medicine Compounding Pharmacy, 350 S Lafayette, South Lyon, MI 48178 All unexpired lots, manufactured and distributed between 07/01/2013 and 10/19/2013; including Lot #s: 07222013@19, 07222013@22, 07222013@23, 07222013@24, Exp 10/20/13; 07232013@1, 07232013@2, 07232013@3, 07232013@5, Exp 10/21/13; 07252013@1, 07252013@3, 07252013@4, 07252013@5, Exp 10/23/13; 07302013@24, 07302013@28, 07302013@30, 07302013@31, 07302013@32, Exp 10/28/13; 08052013@4, 08052013@6, 08052013@7, 08052013@8, 08052013@9, 08052013@10, Exp 11/03/13; 08092013@1, 08092013@8, 08092013@3, 08092013@4,  ...
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Class I Non-Sterility: 50% dextrose is being recalled after particulate matter, later identified as mold, was found floating in the product. Specialty Medicine Compounding Pharmacy, P.C.
Food Chocolate Pecan Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***" product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years Class I Presence of undeclared allergens soy, milk, and pecans Pecan Shed
Food Plain Chocolate Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***" product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years Class I Presence of undeclared allergens soy, and milk Pecan Shed
Food Butter Pecan Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***" product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years Class I Presence of undeclared allergens soy, milk, and pecans Pecan Shed
Food Pecan Shed Special Turtle Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***" product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years Class I Presence of undeclared allergens soy, milk, and pecans Pecan Shed
Food Maple Nut with Pecans Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***" product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years Class I Presence of undeclared allergens soy, milk, and pecans Pecan Shed
Food Dark Chocolate with Pecans Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***" product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years Class I Presence of undeclared allergens soy, milk, and pecans Pecan Shed
Food Tiger Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***" product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years Class I Presence of undeclared allergens soy, milk, and peanuts Pecan Shed
Food Sucrose Free Chocolate Plain Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***" product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years Class I Presence of undeclared allergens soy, and milk Pecan Shed
Food Chocolate Mint Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***" product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years Class I Presence of undeclared allergens soy, and milk Pecan Shed
Food Pumpkin Pie Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***" product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years Class I Presence of undeclared allergens soy, and milk Pecan Shed
Food Pumpkin Pie with Pecans Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***" product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years Class I Presence of undeclared allergens soy, milk, and pecans Pecan Shed
Food Divinity with Pecans Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***" product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years Class I Presence of undeclared allergens soy, milk & pecans Pecan Shed
Food Sucrose Free Chocolate Pecan; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***" product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years Class I Presence of undeclared allergens soy, pecans & milk Pecan Shed
Food Birthday Cake Fudge; Label reads in part "***The Pecan Shed***Fresh Homemade Fudge***ALLERGY INFORMATION: ALL OUR FUDGE IS MANUFACTURED ON THE SAME EQUIPMENT THAT PROCESSES PEANUTS, TREE NUTS, MILK, CREAM, SOY, EGG, WHEAT AND ARTIFICIAL FOOD COLORING.***" product has no lot codes or expiration dates. Per firm, fudge expires in 2 weeks unless frozen. If frozen, it expires in 2 years Class I Presence of undeclared allergens soy & milk Pecan Shed
Food Candied pecans: milk chocolate product has no lot codes or expiration date Class II Presence of undeclared soy allergen Pecan Shed
Food Candied pecans: dark chocolate product has no lot codes or expiration date Class II Presence of undeclared soy allergen Pecan Shed
Food Candied pecans: creamy white product has no lot codes or expiration date Class II Presence of undeclared soy allergen Pecan Shed
Food Candied pecans: honey toasted product has no lot codes or expiration date Class II Presence of undeclared allergens soy Pecan Shed
Devices The Innova 3131IQ (3131-IQ) and 2121 IQ (2121-IQ) biplane systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational angiography procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications. The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. These devices are not intended for mammography applications. Mfg Lot or Serial # System ID 00000550134BU1 2035763100A 00000581573BU3 203932VA4100 00000523132BU9 205783BCL5 00000560743BU7 206598UWBP 00000446090BU3 207351YCL1 00000504213BU0 212305CATH1 00000437215BU7 214324INNOVA2 00000562417BU6 2198864100 00000093723VE5 229228INNOV21C 00000583484BU1 240566CATH2 00000478109BU2 251435ICV3 00000477896BU5 3016094100 00000441137BU7 3018774100 00000466659BU0 303788CL1 00000466984BU2 304424INNOVA 00000445301BU5 309691P3100 00000424103BU0 310423INNOVA1 00000579612BU3 313745IN1 00451726BU4BU8 316268INNOVAA 00000466810BU9 318449INNOVA2 00000482326BU6 3184734100 00000499386BU1  ...
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Class II GE Healthcare has become aware of a potential safety issue involving the innova systems. The Innova system can unexpectedly stop delivering X-rays after a power-on or a reset cycle which may result in the loss of real-time interventional imaging. No injuries have been reported due to this issue. GE Healthcare, LLC
Food Markets of Meijer Pretzel Hamburger Bun, 4 count, NT.WT. 12.0 oz (0.75 lb), 16 oz ( 1 lb) UPC 412500558-2; Ingredients: Enriched Wheat Flour( Wheat Flour, malted barley flour, niacin.....)water, sugar, canola oil, salt, .. , dough conditioner, whey powder, yeast, dough conditioner... soy oil, wheat gluten Allergens: Contains wheat, soy Pretzel Demi Roll 6" , 4 count,12.0 oz (0.75 lb), 16 oz (1 lb) UPC 0-4125000560-2 Ingredients: Wheat Flour...water, sugar, canola oil, salt, dough conditioner, cultured , whey powder, yeast, dough conditioner...soy oil, wheat gluten Allergens: Contains wheat, soy Meijer Distribution, Inc. Grand Rapids, MI 49544 all products with a sell date through 1/15/2014 Class I Source of whey powder ingredient is not identified as milk and the allergen statement does not include milk. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. Meijer Distribution, Inc
Food Markets of Meijer Pretzel Dinner Roll, 8 count, 14.0 oz ( 0.87 lb) UPC 0-4125099036-9 Ingredients: Enriched Flour ( Wheat Flour, Malted Barley Flour, niacin, iran, thiamine mononitrate....) water, sugar, canola oil, salt, why (milk) , yeast, wheat starch soy lecithin, wheat gluten Allergens: Contains wheat, soy Meijer Distribution, Inc. Grand Rapids, MI 49544 all products with a sell date through 1/15/2014 Class II Milk not listed as Allergen. People who have an allergy or severe sensitivity to milk run the risk of serious or life-threatening allergic reaction if they consume these products. Meijer Distribution, Inc
Biologics Fresh Frozen Plasma W036808121748; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells W036808121748; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets Pheresis Leukocytes Reduced W20221380114400; W20221380114400; Class II Blood products, with platelet yields below the specified minimum requirement, were distributed. American National Red Cross, Penn Jersey Region
Devices VERIFY® SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY® SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270°F using typical healthcare dynamic air removal steam sterilization cycles. Model LCC019, Lot #: 024552A Class II STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY® SixCess Challenge Packs incorrectly identifies the lot as Lot #024522A. Steris Corporation
Drugs Triamcinolone Acetonide Cream USP, 0.1%, Net Wt 80 grams per tube, Rx only, E. Fougera & Co., A division of Fougera Pharmaceuticals Inc., Melville, New York 11747, NDC 0168-0004-80, UPC 3 0168-0004-80 8. Lot #: 485P, 486P, 487P, 488P, Exp 06/15; 638P, 639P, 640P, Exp 07/15; 753P, 754P, 755P, Exp 08/15; 898P, 756P, 757P, 758P, 899P, 900P, 901P, 902P, Exp 09/15 Class III Labeling: Label Error on Declared Strength: There is a misprint on the end flap which read 01% rather than 0.1%. Fougera Pharmaceuticals Inc.
Biologics Red Blood Cells Leukocytes Reduced W044213874332; W044213851195; W044213838507 Class II Blood products, collected from a donor who visited a malarial endemic region, were distributed. San Diego Blood Bank
Food HUDSON VALLEY HOMESTEAD BUSHWHACKER'S SAVORY SAUCE, Mild, Net Wt. 14 oz., UPC: 7 51122 00091 0, Hudson Valley Homstead 102 Sheldon Lane Craryville, New York 12521 (518) 851-7336, www.hudsonvalleyhomstead.com all lots Class II Charlemagne's Tree Farm, Ltd. dba HUDSON VALLEY HOMESTEAD recalled BUSHWHACKER'S Savory Sauce "Mild" and "Hot & Spicy" types due to Undeclared Anchovies (fish). Charlemagnes Tree Farm Ltd
Food HUDSON VALLEY HOMESTEAD BUSHWHACKER'S SAVORY SAUCE, Hot & Spicy, Net Wt. 14 oz., UPC 7 51122 00092 1, Hudson Valley Homstead 102 Sheldon Lane Craryville, New York 12521 (518) 851-7336, www.hudsonvalleyhomstead.com all lots Class II Charlemagne's Tree Farm, Ltd. dba HUDSON VALLEY HOMESTEAD recalled BUSHWHACKER'S Savory Sauce "Mild" and "Hot & Spicy" types due to Undeclared Anchovies (fish). Charlemagnes Tree Farm Ltd
Devices Synthes Small Notch Titanium Reconstructive Plate Product Usage: The Synthes Small Notch Titanium Reconstructive Plate set offers fixation for immediate stabilization to allow bone fusion. Commercially pure titanium implants are biocompatible. The wide selection of implants accommodates variable anatomy; precisely crafted instruments facilitate implant placement. Implant plate lateral slant of holes allows for angulation of screws. Elongated central holes provide flexibility in screw placement. Wide selection of length's accommodates individual case requirements. All lots of Parts 489.401, 489.402, 489.412, 489.413, 489.414, 489.415, 489.418, 489.423, and 489.424. Class II Certain modules containing the Synthes Small Notch Titanium Reconstructive Plate set was distributed by Spine sales consultants although it was contraindicated for certain spine applications. Synthes, Inc.
Drugs Carisoprodol Tablets, USP, 350 mg, unit dose blister packages of 100 tablets (10 cards of 10 tablets each), Rx only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL NDC 51079-819-20 Lots and Expiration Dates: 3037463, Expires 2/2014; 3039466, Expires 3/2014; 3040644, Expires 4/2014; 3043463, Expires 6/2014; 3049568, Expires 3/2015 Class III Failed Impurity/degradation Specification Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
Food MARY ANN'S Chocolates Signature Assortment,May Contain Sugar, Chocolate, Butter, Corn Syrup, Assorted Fruit and Nuts, Coconut, Vegetable Oil, Egg or Vegetable Albumen , Salt, Natural and Artificial Flavors and Certified Food Colors. Fruits Contain Sulfur Dioxide, Savory Foods, Inc. Grand Rapids, MI 49507 SIGNATURE ASSORTMENT 5PC, 3 oz UPC 733549030336 SIGNATURE ASSORTMENT 12PC-7OZ PINK BOX UPC 733549030343 CANDY-8OZ HEART BOXED ASSORTED CHOCOLATES 14.0 0Z BOX M CHOCOLATES SIGNATURE ASSORTMENT 13.0 OZ BOX M CHOCOLATES GRAND TRUFFLE ASSORTMENT 14 oz asstd UPC 733549030350 19 oz asstd UPC 733549030367 25 oz asstd UPC 733549030442 CANDY-CANDY-CANDY-GRAND TRUFFLE ASSTD 4 PC CANDY-GRAND TRUFFLE ASSTD 9 PC CANDY-ASSORTED SNAPPERS 5PC-5OZ PINK BOX Pictured Label placard on all boxes, all varieties: Mary Ann's Chocolates Signature Assortment: Lemon Creme Milk; Cherry Cordial Milk Raspberry Cream Milk, Tiramisu Truffle Dark, Caramel Milk/Dark Raspberry Truffle Dark, Almond Cluster Milk/Dark Chocolate; Coconut Cluster Milk, Chocolate Insanity Truffle Dark, Peanut Cluster Milk, Coconut Creme Milk, Maple Cream Milk, Pecan Cluster Milk, Irish Creme Truffle Dark No manufacturing codes Class II The ingredient panel for assorted chocolates did not identify peanuts and specific tree nuts (almond, walnut, pecan, pistachio, cashew, macadamia and coconut). The source of lecithin was not identified as soy and lakes yellow 5, lakes yellow 6, red 3, red 40 and blue lake 1 were not identified as ingredients. Savory Foods, Inc.
Veterinary ***Joint Support for Dogs***SYNOVIAL-FLEX SOFT CHEWS***TRP*Advanced Soft Chew Technology***Combining Glucosamine HCl, MSM, Creatine Monohydrate, Perna Canaliculus, Omega-3 Fatty Acids and Antioxidants in a Palatable Liver Flavored Chew***SOGEVAL***Shared solutions***Net Content: Contains 120 soft chews*** Model # FNGL9002120, Lot # 52070-1 exp 12/2015. Class III Consumer complaint of the smell of their Synovial Flex Soft Chews associated with Joint Max Double Strength soft chews that were inadvertently mislabeled as Synovial Flex Soft Chews. Sogeval Laboratories Inc
Devices plastic tissue. The IHC PR Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitation measurement of PR (Progesterone Receptor) in formalin-fixed, paraffin-embedded normal and neoplastic tissue. It is indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes of breast cancer. Note: The IHC ER and PR Image Analysis applications are an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of estrogen and progesterone receptor proteins. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the ER and PR reagent/kit used to assure the validity of the IHC ER and PR Image Analysis application assisted scores. IHC PR Breast Tissue Manual Read of Digital Slides: The ScanScope® System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape. The ScanScope® system is intended for use as an aid to the pathologist in the detection and quantitative measurement of PR (Progesterone Receptor) by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for PR on a computer monitor. It is indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes of breast cancer. 23elHCKIT2500, 23elHCKIT5000, 23elHCKIT500. Class II In an abundance of caution, Aperio (now known as Lecia Biosystems) is providing additional information to clarify that the use of Digital IHC Breast/ER/Dako Image Analysis, Digital IHC Breast/HER2 Digital Read, Digital IHC Breast/HER2/Dako Image Analysis, Digital IHC Breast/PR Digital Read and Digital IHC Breast/PR/Dako Image Analysis with the RUO products identified in that earlier notification is also for Research Use Only and not for use in diagnostic procedures. As a result, we are including with this notice updated manuals for the image analysis algorthithms listed above so that the intended use in the hardware and software manuals is consistent. Leica Biosystems Imaging, Inc.
Devices VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators; REF/CATALOG # 684 4055, IVD --- COMMON/USUAL NAME: VITROS Vitamin D Calibrators -- Ortho-Clinical Diagnostics High Wycombe HP12 4DP, UK --- For use in the calibration of the VITROS ECi/ECiQ Immunodiagnostic Systems, the VITROS 3600 Immunodiagnostic Systems, and the VITROS 5600 Integrated System for the quantitative measurement of total 25-OH Vitamin D in human serum. 0020, 0030, 0040, 0050, 0060, 0070, 0081, 0090, 0100, 0110 Class III Ortho Clinical Diagnostics has determined that the VITROS Immunodiagnostic Products 25-OH Vitamin D Total Calibrators, Lots 0091 through 0235, used with VITROS Immunodiagnostic Products 25-OH Vitamin D Total Reagent Packs, may generate negatively biased results. As a result, users must immediately discontinue using all current lots of VITROS 25-OH Vitamin D Total Calibrators and Reagent Packs. Ortho-Clinical Diagnostics
Devices Treatment packs used on the VisuMax Laser Keratome. Size M Manufactured by Carl Zeiss Meditec AG, Jena, Germany. The VisuMax Laser Keratome is indicated for the following: In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring lamellar resection of the cornea. Patients undergoing surgery or other treatment requiring initial lamellar resection of the cornea. In the creation of a lamellar cut/resection of the cornea for lamellar keratoplasty. In the creation of a cut/incision for penetrating keratoplasty and corneal harvesting. P/N 1462-333, Size M, Lot # M130010 Class II Carl Zeiss Treatment pack, lot number M 130010, size M, may actually contain size S. Carl Zeiss Meditec AG
Devices CELLTRACKS ANALYZER II® (Product Code 9555) Product Usage: The CELLTRACKS ANALYZER II® is a semi-automated fluorescence microscope, consisting of the analyzer, a dedicated computer with CELLTRACKS® software, monitor, keyboard, mouse and uninterruptible power supply (UPS). The system also supports an optional Remote Review Workstation (RRW), which consists of a dedicated computer with CELLTRACKS® software, monitor, keyboard and mouse. Use of this product requires training and should be used under the supervision of laboratory management. The CELLTRACKS ANALYZER II® is for analysis of rare cells that are isolated from biological fluids including whole blood. It is used in conjunction with the CELLTRACKS® AUTOPREP® System, which automates and standardizes the sample preparation with specific reagent kits. An optional Remote Review Workstation is also available to provide the capability to review images and report results remotely. First: K050145, cleared 15 March 2005 Latest: K130794, cleared 20 June 2013 9555 Serial numbers: CT1106005 CT1104002 CT1108006 CT1111009 CT1201001 CT1203004 CT1205011 CT1205012 CT1206013 CT1210022 CT1210024 Class II Janssen Diagnostics, LLC received complaints of camera failures on the CELLTRACKS ANALYZER II®. Veridex, LLC
Biologics Red Blood Cells Leukocytes Reduced W333613106336 Class II Blood product, which was labeled as leukoreduced, but exceeded the acceptable limit for white blood cell count for leukoreduced products, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced W069113134332 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Mississippi Blood Services Inc.
Biologics Recovered Plasma W069113134332 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. Mississippi Blood Services Inc.
Devices Philips HeartStart MRx Monitor/Defibrillator Models: M3535A and M3536A with Q-CPR Meter Option B08 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician MRx units with the Q-CPR Meter option B08 and with a serial number within the range: US00100253 and US00571587 Class II When the HeartStart MRx.is used with the Q-CPR Meter in defibrillation mode, the Q-CPR Meter may incorrectly display the Do Not Touch the Patient icon. Philips Medical Systems, Inc.
Devices bioMerieux PREVI Isola System (General purpose,microbiology, diagnostic Medical Device), (REF 29500/29500R), bioMerieux, Hazelwood, MO. Serial number range: AS 180-00001 to AS 180-00476 Class II The firm has determined the product may fail to dispense the sample to the agar plate resulting in a "failure to dispense" in conjunction with urine specimens. This could lead to a "false" negative growth result. Biomerieux Inc
Devices GE Healthcare Infinia and Infinia Hawkeye Nuclear Medicine Systems. For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. Serial Numbers for all devices: 22, 343, 1002, 1003, 1006, 1007, 1008, 1010, 1012, 1013, 1016, 1018, 1019, 1021, 1025, 1026, 1027, 1034, 1035, 1038, 1039, 1042, 1043, 1046, 1056, 1058, 1060, 1061, 1065, 1066, 1069, 1072, 1073, 1074, 1075, 1076, 1078, 1080, 1081, 1085, 1086, 1091, 1095, 1099, 1100,  ...
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Class II Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. This generated both a visual and audio alert condition on both the console and the gantry. No injuries have been reported. GE Healthcare, LLC
Devices GE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping. all serial numbers are listed in Product 1 Class II Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. This generated both a visual and audio alert condition on both the console and the gantry. No injuries have been reported. GE Healthcare, LLC
Devices Elscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping. all serial numbers are listed in Product 1. Class II Potential safety issue related to unintended radial detector motion, which may occur during patient setup or at the end of a patient scan. This failure mode has been observed on a single system, in which the detector moved to the home position and then slowly starting drifting inward toward the patient. This generated both a visual and audio alert condition on both the console and the gantry. No injuries have been reported. GE Healthcare, LLC
Devices RetCam 3, RetCam Portable and RetCam Shuttle; manufactured by Clarity Medical Systems, Inc.; Pleasanton, CA 94588. General ophthalmic imaging including retinal, corneal and external imaging. no lot numbers: RetCam 3 (RC3, Part number 21-100500; Serial numbers: RC3125 RC6003 RC6004 RC6005 RC6006 RC6007 RC6008 RC6009 RC6010 RC6011 RC6012 RC6013 RC6014 RC6015 RC6016 RC6017 RC6018 RC6019 RC6020 RC6021 RC6022 RC6023 RC6024 RC6025 RC6026 RC6027 RC6028 RC6029 RC6030 RC6031 RC6033 RC6034 RC6035 RC6036 RC6037 RC6038 RC6039 RC6040 RC6041  ...
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Class II Software anomaly for RetCam 3, RetCam Shuttle and RetCam Portable with software versions 6.0.x, 6.1. x and 6.2x where the patients age is calculated incorrectly. Clarity Medical Systems Inc
Devices Philips HeartStart MRx Monitor/Defibrillator Model numbers: M3535A, M3536A, M3536M,M3536M4,M3536M6,861288,861289,861464,861483,and 861491 Serial numbers within the range: US00100204 to US00570921 Class II MRx may display a Red X in the Ready For Use (RFU) indicator during automated tests informing the user that a failure has been detected that may prevent the delivery of a shock and pacing Philips Medical Systems, Inc.
Food Valued Naturals Natural Coconut Net wt. 8oz (216.80g) Imported by Philippines International Foodsource LLC 52 Richboynton Rd, Dover, NJ 07801 Packaged in 8 oz bag 12 per case. UPC 7-90429-22603-6 Retail Lots - 62289, 62752, 63046, 63374, 63541, 63614, 63800 UPC 7-90429-22603-6 12x6x6 (5# boxes) - 63059 Class III NYSDAM Laboratory Analysis Reports has determined that Valued Naturals Natural Coconut contains 28.1 ppm sulfites. International Foodsource, LLC
Devices Smith & Nephew RENASYS Soft Port REF: 66800799 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps) ALL LOT #s 2013010311 and lower Class II Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wound contact dressing and may adversely affect the performance of the blockage alarm. Smith & Nephew Inc.
Devices Smith & Nephew RENASYS-F Foam Dressing Kit with Soft Port REF #'s: 66800794, 66800795, and 66800796 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps) ALL LOT #'s: 2013011828 and lower- Small, 2013010125 and lower- Medium, and 2013011692 and lower - Large Class II Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wound contact dressing and may adversely affect the performance of the blockage alarm. Smith & Nephew Inc.
Devices Smith & Nephew RENASYS-F XL with Soft Port REF #: 66800797 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps) ALL LOT #: 2013011830 and lower Class II Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wound contact dressing and may adversely affect the performance of the blockage alarm. Smith & Nephew Inc.
Devices Smith & Nephew RENASYS-Gauze with Soft Port Kit REF #'s: 66800933, 66800934, 66800935, and 66800936 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps) ALL LOT #'s: 2013020417 and lower - Small, 2013020209 and lower- Medium, 2013020382 and lower - Large, and 2013020501 and lower- X-Large Class II Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wound contact dressing and may adversely affect the performance of the blockage alarm. Smith & Nephew Inc.
Devices Smith & Nephew RENASYS-G Sterile, Gauze Dressing Kit with Soft Port REF #'s: 66800961 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps) ALL LOT #s 2013020740 and lower Class II Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wound contact dressing and may adversely affect the performance of the blockage alarm. Smith & Nephew Inc.
Devices Smith & Nephew RENASYS-AB Abdominal Dressing Kit with Soft Port REF #'s: 66800980 (The RENASYS Soft Port Dressing Kits are used in conjunction with negative pressure wound therapy pumps) ALL LOT #'s 2013010287 and lower Class II Reports of wound fluid and /or blood that were not evacuated from beneath the wound dressing and the pump blockage alarm did not activate has been associated with inadequate Soft Port sealing at the wound site or improper positioning of the Soft Port orifice over the wound contact dressing drape. Inadequate sealing can result in air leaks and contribute to inefficient fluid evacuation from the wound contact dressing and may adversely affect the performance of the blockage alarm. Smith & Nephew Inc.
Food Roasting Cinnamon Butternut Squash Net Wt. 2 lbs (907 g) Foam Tray with 3 per case. Keep Refrigerated Distributed by Renaissance Food Group LLC UPC 825786790333 Best by Dates of 1/5/14; 1/7/14; 1/8/14 Class II Roasting cinnamon butternut squash is mislabeled. F & S Produce Co., Inc.
Food Colon Rebuild I (90 capsules), 2boxes x 240 bottles, 1box x 200 bottles. Colon Rebuild I, Lot 1471 Class II Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol. Global Vitality, Inc. dba Enzyme Process International
Food Fat Sugar (bulk), 3 boxes x 12 kg, 1 box x 8.76 kg. Lot 1845 Class II Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol. Global Vitality, Inc. dba Enzyme Process International
Food Adrenal Support (bulk), 4 boxes x 12 kg, 1 box x 11.48 kg. Lot 2037 Class II Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol. Global Vitality, Inc. dba Enzyme Process International
Food Energy Clarity (bulk), 6 boxes x 15 kg, 1 box x 10.55 kg. Lot 1843 Class II Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol. Global Vitality, Inc. dba Enzyme Process International
Food Multi Vitamin (bulk), 6 boxes x 12 kg, 1 box x 5.5kg. Lot 1671 Class II Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol. Global Vitality, Inc. dba Enzyme Process International
Food Total Digestion, Lot 1635, 4 boxes x 9.92 kg. Lot 1841, 4 boxes x 12 kg, 1 box x 11.24 kg. Lot 2017, 3 boxes x 10 kg, 1 box x 9.32 kg. Lot 1635, 1841, and 2017 Class II Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol. Global Vitality, Inc. dba Enzyme Process International
Food Pain Power, 100 vegetarian capsules, 55 boxes x 72 bottles, 1 box x 7 bottles. Lot 1533 Class II Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol. Global Vitality, Inc. dba Enzyme Process International
Food Super Digestayme, 200 count, 2 boxes x 72 bottles, 1 box x 55 bottles. 300 count, 4 boxes x 72 bottles, 1 box x 12 bottles. Lot 1585 Class II Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol. Global Vitality, Inc. dba Enzyme Process International
Food Colon Rebuild II, 210 capsules, 6 boxes x 72 bottles, 1 box x 70 bottles. Lot 1579 Class II Global Vitality is recalling dietary supplements because they may be contaminated with chloramphenicol. Global Vitality, Inc. dba Enzyme Process International
Devices Panaroma Central Station Product Usage: This device can view real time, store, print, graph, and trend patient clinical and demographic data. The device can also set independent alarm limits for data send by the bedside monitor. p/n 0998-00-0708-01; 0998-UC-0708-01 and 0020-00-0205-XXX Class II Mindray has identified two issues with the Panorama Central Station. Full Disclosure data may lag behind the Panorama system time clock when the Panorama Central Station is in use with Mindray¿s V-Series Monitor. Additionally, event indicators lag behind the Panorama system time clock when the Panorama Central Station is in use with a Panorama Telepack. Mindray DS USA, Inc. dba Mindray North America
Food Classic Sysco Custom Ready to Use Cherry Pie Filling; with other Natural Flavors #10 can - Net wt 7 lbs (3.18kg) UPC 1 00 74865 38257 8 Manufactured for Sysco by Lyons Magnus, Fresno, CA Item 1846; Cherry Pie code 8004 SUPC 6346134 Class II Precautionary withdrawal after inspection found metal on metal contact on an augur used in production. No metal has been discovered in any of the product. Lyons Magnus
Food Classic Sysco Custom Ready to Use Blueberry Pie Filling; Artificial Flavor #10 can - Net wt 7 lbs 1 oz (2kg) UPC 1 00 74865 38258 5 Manufactured for Sysco by Lyons Magnus, Fresno, CA Item 1847; Cherry Pie code 9204 SUPC 6346167 Class II Precautionary withdrawal after inspection found metal on metal contact on an augur used in production. No metal has been discovered in any of the product. Lyons Magnus
Food MORRISON'S BROWN GRAVY MIX, NET WT 13 OZ (369 g) mislabeled as MORRISON'S PANCAKE MIX, NET WT 5 LB (2.27 kg) Lot number 3357 Class II brown gravy mix product mislabeled as pancake mix, resulting in undeclared soy (as hydrolyzed vegetable protein) C. H. Guenther & Sons, Inc.
Devices VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011, 25-Test kit. Product Usage: The VerifyNow System is a turbidimetric based optical detection system which measures platelet-induced aggregation. The system consists of an instrument, a disposable test device and quality control materials. The VerifyNow IIb/IIIa Test is a semi-quantitative, whole blood platelet function test used to measure glycoprotein (GP) IIb/IIIa receptor blockade in patients treated with abciximab or eptifibatide. VerifyNow Ilb/Illa Test results should be interpreted in conjunction with other clinical and laboratory data available to the clinician. Lot/Serial No. WC0182B, WC0182C, WC0182A, WC0182D, WC0182E, WC0182F, WC0182G, WC0180C, WC0180E, WC0180F, WC0181A, WC0181C, WC0181D, WC0181F, WC0180A, WC0180B, WC0180D, WC0181B, WC0181E, WC0181G, WC0181H, WC0181J, WC0181K. Class II Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an erroneous low platelet aggregation unit (PAU) result. An erroneous low PAU result may cause a low percent inhibition calculation or low baseline PAU. Accumetrics Inc
Food Jalapeno Ground 40, Elite Spice Code #JP9520, 50 lb poly-lined cartons labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794*** Lot 1-227954 Class I Bulk spice for futher manufacturing may be contaminated with Salmonella. Elite Spice Inc.
Food Jalapeno Nut Seasoning, Elite Code # 35076A2, 50 lb poly-lined cartons labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794*** Lot 1-230880 Class I Bulk spice for futher manufacturing may be contaminated with Salmonella. Elite Spice Inc.
Food Chipotle Nut Seasoning, Elite Code # 38113A2, 50 lb poly-lined cartons labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794*** Lot 1-230879 Class I Bulk spice for futher manufacturing may be contaminated with Salmonella. Elite Spice Inc.
Food Ole Hot Chorizo Seasoning, Elite Spice # 32581A9, 32 lb poly-lined carton, labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794*** Lot 1-230758 Class I Bulk spice for futher manufacturing may be contaminated with Salmonella. Elite Spice Inc.
Food Mexican Style Mild Chorizo, Elite Spice # 32582A9, 24 lb poly-lined carton, labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794*** Lot 1-230647 Class I Bulk spice for futher manufacturing may be contaminated with Salmonella. Elite Spice Inc.
Food Jalapeno Burger Seasoning, Elite Spice # 32680B2, 50 lb poly-lined carton, labeled in part ***Elite Spice Inc. 7151 Montevideo Road, Jessup MD. 20794*** Lots 1-230813 and 1-230814 Class I Bulk spice for futher manufacturing may be contaminated with Salmonella. Elite Spice Inc.
Devices MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given temperature range of blood cardioplegic and crystalloid cardioplegic solutions during extracorporeal circulation. The product is designed for single use only, for an application period of no longer than 6 hours. Order Number Model Number and Description Lot number 70105.0647  ...
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Class II The MAQUET post-marketing vigilance program has identified a discrepancy that the desired cardioplegia temperature may not be obtained when the PLEGIOX Cardioplegia Heat Exchanger (PLEGIOX) is used in conjunction with a heater/cooler unit. Maquet Cardiovascular Us Sales, Llc
Devices Mar Cor Purification CWP Reverse Osmosis System. Models 101, 102, 104, and 106. serial numbers: 1289064, 1289069, 1289159, 1289259, 1289387, 1289650, 1289747, 1289826, 1289949, 1290088, 1290151, 1290333, 1290367, 1290480, 1290489, 1290845, 1290988, 1291042, 1291120, 1291233, 1291373, 1291378, 1291634, 1291777, 1291828, 1291933, 1292031, 1292114, 1292185, 1292185, 1292192, 1292391, 1292546, 1292597, 1292670, 1292674, 1292899, 1292960, 1293010, 1293039, 1293185, 1293190, 1293311, 1293379, 1293414, 1293687, 1293724, 1293771,  ...
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Class II There exists a potential situation with the crimp connection at the pump head assembly. The potential exists that the reverse osmosis pump head wiring could build resistance resulting in resistive heating of the surrounding components. If this occurs, the pump head assembly may experience melting of the plastic components and potentially create smoke/fire and shut down of the unit. Mar Cor Purification
Drugs Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50 Lot # 1826E131, Exp 04/2015 Class II Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg. Actavis Elizabeth LLC
Devices Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC,± 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers. Catalog number 0007Cm; lot number 1211158R; Expiration May 14, 2014. Class II Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards the end of their shelf life due to use of dated but unexpired secondary stock used to create the products. Lin-Zhi International Inc
Devices Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is prepared from non-sterile urine and should be handled as potentially infectious. IVD; The Cannabinoids (cTHC also known as THC version c) DAU negative and positive controls are human urine-based liquids and ready to use. The constituent is a processed drug-free human urine matrix, containing buffers, stabilizers, and less than 0.09 % of sodium azide. The controls are prepared by spiking known concentrations of 11-nor-9-THC-9-COOH into the drug-free matrix. cTHC is referenced as an abbreviation for 11-nor-9-THC-9-COOH and it may be referred to simply as THC in the text of this report. The controls contain 37.5 ng/mL and 62.5 ng/mL of cTHC,± 10% by GC/MS or LC/MS analysis. Lin Zhi International inc. Sunnyvale, CA 94085 The Cannabinoid Drug of Abuse (DAU) negative and positive controls are used as assay quality control material to monitor the precision of the Lin-Zhi International, Inc. (LZI) Cannabinoid Enzyme Immunoassay (Ref # 0070c) on a number of automated clinical chemistry analyzers. Catalog number 0008c; lot number 1211160R; Expiration May 14, 2014. Class II Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Control Level 2 of the lots mentioned may give decreased concentration readings towards the end of their shelf life due to use of dated but unexpired secondary stock used to create the products. Lin-Zhi International Inc
Devices Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Product Usage: The ABX PENTRA ML is a software data management system intended for use on ABX Hematology Analyzers. Model/Part #(s): A11A01652 Lot/Serial #(s): N/A Software Version(s): All versions are subject to this correction. Shelf Life: N/A Class II HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) due to a software bug with the potential of transmitting incorrect results to the Laboratory Information System. Horiba Instruments, Inc dba Horiba Medical
Food STONEWALL KITCHEN brand Chocolate Coconut Cupcake Mix, Net Wt. 22.5 oz. (637.9 g), UPC 7 11381 31535 4 -- DISTRIBUTED BY STONEWALL KITCHEN, STONEWALL LANE, YORK, ME 03909 Enjoy By Dates: 17 APR 2014 1, 16 AUG 2014 1, 03 SEPT 2014 1, 21 OCT 2014 1, 27 NOV 2014 1, 20 JAN 2015 1, 7 FEB 2015 1 Class II Labeling error. The cupcake mix is made with coconut milk powder which contains the sub-ingredients coconut milk and sodium caseinate (milk). These are listed in the ingredient statement. The "Contains" allergen statement lists Soy, Tree Nuts (coconut), and Wheat, but Milk is not listed. Raymond-Hadley Corp.
Devices PENTARAY NAV High-Density Mapping Catheter, Catalog No. D128201, D128202, D128204, D128205. The Biosense Webster PENTARAY NAV High-Density Mapping Catheter is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart. Lot Numbers: 15791519L 15803349L 15825343L 15845012L 15852437L 15859153L 15869785L 15793496L 15803350L 15825344L 15845013L 15852438L 15859154L 15869786L 15793497L 15803351L 15825345L 15845014L 15854132L 15859155L 15869787L 15793499L 15803352L 15825346L 15845015L 15854136L 15859156L 15869788L 15793500L 15803353L 15825347L 15845016L 15854141L 15859157L 15869789L 15793502L 15803354L 15825348L 15845017L 15854145L 15859158L 15869790L 15795833L 15803355L 15825863L 15845018L 15854147L 15859159L  ...
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Class II Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have partial tip separation from the catheter shaft. Biosense Webster, Inc.
Biologics Red Blood Cells Leukocytes Reduced W051714101583 Class III Blood product, for which the additive solution was not added during manufacturing, was distributed. Rhode Island Blood Center
Biologics Blood and Blood Products for Reprocessing W036813023947 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Plasma Frozen within 24 hours (FP24) W036813256009 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036813256009 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells W036813023947, 2300334 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036813817523, 2909442 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. OneBlood, Inc.
Devices Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception). Lots: MK761655, MK764022, MK767655, MK526401 Class II Due to an anomaly in the packaging process for specific lots of Disposable Falope-Ring Band Kit, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. The breach may or may not be easily seen. Gyrus Medical, Inc
Biologics Terasaki HLA Tissue Typing Trays (HLA Class II Tissue Typing Trays only). Terasaki HLA Tissue Typing Trays are for use in determining HLA cell surface antigens with a complement dependent microlymphocytotoxic technique. BK840023 Catalog ID - DR72; Lot Number - 030; Batch 087 Class III HLA typing assay, associated with false positive results, was distributed. One Lambda Inc
Devices XiO RPT System The XiO RTP System is used to create treatment plans for any cancer patient for whom external beam radiation therapy or brachytherapy has been prescribed. The system will calculate and display, both on screen and in hard-copy, either two or three dimensional radiation dose distributions within a patient for a given treatment. Versions 4.1 and higher Class II Dose and Monitor Unit values are not computed correctly when Elekta Motorized Wedges are used with Dynamic Conformal arcs. Elekta, Inc.
Devices REF 623401 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time. 249649, 102928, 102929, 109312, 128472, 142839, 142840, 142841, 162485, 196050, 196051, 196052, 211382, 211387, 213581, 227387, 231687, 249644, 249647, 269701, 269702, 288346, 298769, 298770, 298772, 306503, 306505, 329328, 338142, 346434, 354575, 360633, 360634, 366429, 366430, 373254, 378641, 378642, 378644, 402462, 403004, 403005, 403007, 403008, 421300, 438246, 438247, 438248, 438249, 452447,  ...
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Class II DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM® Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the packaging redesign because all units within recalled lots may not be affected. In addition, pre-implantation inspection of the implants packaging will allow the surgeon to determine whether there are any breaches in the packaging of individual S-ROM Noiles Rotating Hinge Femur with Pin devices. Implants with intact packaging may be used as intended. DePuy Orthopaedics, Inc.
Devices REF 623401 R, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Medium, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time. 102325, 102326, 109315, 109316, 120082, 128475, 142843, 142845, 162487, 197812, 197813, 197814, 207924, 222654, 222657, 231689, 231690, 236435, 236442, 261758, 265711, 265714, 265715, 265717, 282997, 285154, 285155, 289096, 302804, 302807, 302808, 317754, 317755, 338154, 338155, 338157, 354580, 360635, 360636, 366432, 378645, 378647, 378650, 400505, 400506, 402456, 414735, 414736, 414737, 430481,  ...
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Class II DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM® Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the packaging redesign because all units within recalled lots may not be affected. In addition, pre-implantation inspection of the implants packaging will allow the surgeon to determine whether there are any breaches in the packaging of individual S-ROM Noiles Rotating Hinge Femur with Pin devices. Implants with intact packaging may be used as intended. DePuy Orthopaedics, Inc.
Devices REF 623411 L, S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time. E1VHS4, 430482, 338164, 373256, 395802, 409578, 448220, 409582, 238688, 430483, 306508, 329330, 264451, 448222, 216275, 373255, 346439, 409580, 338165, 250929, 360638, D65FJ4, 216277, 395804, EJ7F14, 254740, 302815, FF8DW4, 314821, 464642, 338166, FA4FP4, FA4FT4, 238411LC, 464643, 278448, 409579, 464640, 395803, 088411LA, 308248, FF8DX4, 196411LA, 448227, C1VCE4, 402352, 346437, 366433, 238687, 172188,  ...
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Class II DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM® Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the packaging redesign because all units within recalled lots may not be affected. In addition, pre-implantation inspection of the implants packaging will allow the surgeon to determine whether there are any breaches in the packaging of individual S-ROM Noiles Rotating Hinge Femur with Pin devices. Implants with intact packaging may be used as intended. DePuy Orthopaedics, Inc.
Devices REF 623411 R S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right, Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time. 102932, 102933, 102934, 120086, 142854, 156155, 156156, 156157, 162493, 172189, 181460, 181462, 193663, 231692, 231695, 236448, 241369, 241371, 246794, 261763, 269712, 278450, 278451, 278452, 282999, 283000, 283001, 291033, 291034, 302817, 306511, 306512, 306513, 317757, 317758, 329334, 338167, 338168, 346440, 360639, 360640, 360641, 366434, 366435, 366436, 378652, 392023, 400513, 400514, 406837,  ...
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Class II DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the packaging redesign because all units within recalled lots may not be affected. In addition, pre-implantation inspection of the implants packaging will allow the surgeon to determine whether there are any breaches in the packaging of individual S-ROM Noiles Rotating Hinge Femur with Pin devices. Implants with intact packaging may be used as intended. DePuy Orthopaedics, Inc.
Devices REF 623421 L S-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Left , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time. Both left and Right 102935, 110571, 114271, 114274, 114277, 128477, 132946, 142857, 156158, 162498, 162499, 162500, 172191, 172194, 193664, 193668, 217297, 224704, 229189, 229192, 229195, 229196, 236454, 236463, 236466, 241379, 249713, 249714, 249715, 254742, 254743, 260549, 260552, 269715, 269717, 278454, 278456, 283005, 283006, 283007, 291037, 291038, 291039, 295391, 302819, 306516,  ...
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Class II DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the packaging redesign because all units within recalled lots may not be affected. In addition, pre-implantation inspection of the implants packaging will allow the surgeon to determine whether there are any breaches in the packaging of individual S-ROM Noiles Rotating Hinge Femur with Pin devices. Implants with intact packaging may be used as intended. DePuy Orthopaedics, Inc.
Devices REF 623421 RS-ROM Noiles Rotating Hinge, Femoral Rotating Hinge Cemented (with Pin), Right , X-Small, Sterile R Qty 1 The S-ROM Hinged knee femoral component is used in revision surgeries when there is significant bone loss or ligament instability and additional support is needed. S-Rom femorals and inserts are brought into nearly every revision case as backup should the MCL become compromised during the procedure. If additional constraint is required the surgeon can use the S-ROM femoral and insert. S-ROM femorals are used in less than 10% of knee revision procedures, but are present almost all the time. Both Right and Left 102935, 110571, 114271, 114274, 114277, 128477, 132946, 142857, 156158, 162498, 162499, 162500, 172191, 172194, 193664, 193668, 217297, 224704, 229189, 229192, 229195, 229196, 236454, 236463, 236466, 241379, 249713, 249714, 249715, 254742, 254743, 260549, 260552, 269715, 269717, 278454, 278456, 283005, 283006, 283007, 291037, 291038, 291039, 295391, 302819, 306516, 306517,  ...
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Class II DePuy Orthopaedics has identified the potential for holes to develop in the inner and outer flexible pouches that form the sterile barrier for S-ROM Noiles Rotating Hinge Femur with Pin devices. The outer carton and shrink wrap are intact. A package redesign is underway to resolve this issue. S-ROM Noiles Rotating Hinge Femur with Pin devices will remain in US Distributors inventory during the packaging redesign because all units within recalled lots may not be affected. In addition, pre-implantation inspection of the implants packaging will allow the surgeon to determine whether there are any breaches in the packaging of individual S-ROM Noiles Rotating Hinge Femur with Pin devices. Implants with intact packaging may be used as intended. DePuy Orthopaedics, Inc.
Devices Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Tyvek® polyester peel pouch, 25 pouches per box. This device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus used to remove surgical smoke and fluids from the site. The device is intended for single use; it is not intended to be cleaned or reused. Catalog Number: 0043-25 Lot Number: 132405 Exp. Date: 07-2018 Class II Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord and 132405 Holster, Sterile, Disposable, Lot 132405 due to the potential for a small number of these suction coagulators to self-activate immediately on connection to the electrosurgical generator and to remain activated until it is disconnected. Megadyne Medical Products, Inc.
Biologics Cornea 111215OD; 111215OS 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. Upstate New York Transplant Services
Devices Boston Scientific, RunWay" Guide Catheter, UPN H749389696640, Catalog Number 38969-664. 2013040058 Class II Boston Scientific is initiating this Recall Removal of one lot (2013040058) of the RunWay" Guide Catheter. Boston Scientific has become aware that the sterile pouch of the devices from this lot may not be completely sealed and sterility may be compromised. To date, Boston Scientific has received one complaint for this issue. The most common adverse health consequence expected from an unsealed pouch is a transient bacteremia, which may require antibiotic therapy. Boston Scientific Corporation
Biologics Cornea 01272013060OS; 01272013060OD Class II Human corneas, recovered from a donor who was not properly evaluated for hemodilution, were distributed. Mid-America Transplant Services
Drugs Photofrin (porfimer sodium) for Injection, 75 mg Single Use Flip-Top Vial, Rx Only. Manufactured for: Pinnacle Biologics, Inc. Bannockburn, IL 60015. NDC:76128-155-75 Lot Number: 0M396; Expiry: Nov 2014 Class III Stability Data Does Not Support Expiry: Printed expiration date should be Nov 2013 rather than Nov 2014. Pinnacle Biologics Inc
Biologics Blood and Blood Products for Reprocessing W036808110290; Class III Blood products, collected from a donor whose suitability to donate was not fully evaluated, was distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036808110290; Class II Blood products, collected from a donor whose suitability to donate was not fully evaluated, was distributed. OneBlood, Inc.
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