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U.S. Department of Health and Human Services

Enforcement Report - Week of March 2, 2016

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices Synthes Small Electric Drive (SED) All lots from production launch Class II May operate solely in reverse mode, not operate in reverse mode when intended, not function or an unintentionally start. The Anspach Effort, Inc.
Veterinary Mod LabDiet 5058 w/150 ppm Fenbendazole Plastic sealed bag in a box; 1 - 480 kg package Product Code: 57T7; Manufactured 01/26/2015 Class I A manufacturing error resulting in Ivermectin used in place of Fenbendazole in custom research diet for mice resulted in mice mortality. Purina Animal Nutrition LLC
Veterinary Product is a custom feed, "Moravec" goat pellets (16.5 lbs rumensin per ton) packaged into 50 lb. bags. Manufactured by Frontier Cooperative Columbus, NE 237.15.1 manufactured on or about 8/27/2015 Class I Product contained elevated levels of monensin which resulted in animal death. Frontier Cooperative Co
Veterinary Bulk Prestart 550 non-medicated nursery swine feed manufactured with Start 300 Vitamin Pac. The responsible firm is Kassik Milling, Milligan, NE. lots: 15040912,15041403, 15042102, 15050107, 15040922, 15042222, 15043014, 15043013, 15041017, and 15042215 Class I Product is superpotent for Vitamin A. Kassik Milling Co Inc
Veterinary Bulk Start 300 non-medicated nursery swine feed manufactured with Start 300 Vitamin Pac. The responsible firm is Kassik Milling, Milligan, NE. lots: 15040913, 15041404, 15042101, 15050108, 15042016, 15042223, 15043015, 15041627, and 15043007 Class I Product is superpotent for Vitamin A. Kassik Milling Co Inc
Devices Shuttle Select Slip-Cath Catheter. Angiographic catheter. For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide. Product numbers: SCBR4.5-35-135-P-NS-ANG-SHTL SCBR4.5-35-135-P-NS-ANG-SHTL-JP SCBR4.5-35-150-P-NS-0-SHTL SCBR4.5-35-150-P-NS-ANG-SHTL SCBR4.5-35-75-P-NS-ANGSHTL SCBR5.0-35-90-P-NS-RUC Lots: 4323524 4325406 4334525 4338030 4339752 4360231 4364180 4368348 4393439 4413850 4423906 4428682 4448476 4469769 4482723 4578086 4578087 4586710 4587403 4594134 4598548 4600573 4605628 4605629 4605630 4605631 4611045 4611046 4613055 4616267 4619949 4625448 4629806 4631548 4640682 4643656 4648596 4655177 4655178 4661955 4661956 4677333 4693109 4698226 4723849 4727230 4732759 4732760  ...
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Class I Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result. Recall expanded 10/08/2015 to include additional catheters. Cook Inc.
Devices GE Precision MPi is an all-digital multipurpose tilt-C x-ray system, intended for a multitude of diagnostic procedures, including radiology, fluoroscopy, interventional procedures, vascular and non-vascular procedures, and specialized applications including angiographic studies. NRT no.: 02980000 Class II It was discovered that the Remote Touch Panel (RTP) of the GE Precision MPi X-ray system may not always boot up as intended and needs to be updated to properly accomplish its intended purpose. Regulatory Insight, Inc
Food Labeled "CSFISHERY COMMUNITY SUPPORTED FISHERY Wild Albacore Tuna, 64 oz.., Ingredients: Oregon Albacore Tuna, Sea Salt" Label is black ink on an off white label. No UPC OCK 16AAPR2017 Class II This voluntary recall was initiated after the manufacturing firm notified the recalling firm that products were possibly under- processed. Under-processed seafood could lead to contamination with Clostridium botulinum. CSFPDX, LLC
Food FROZEN KINGFISH STEAK, QF, IVP, Size: 10/12 OZ, WEIGHT 22 LBS, IMPORTER:PRESIDENT EAST COMPANY, PRODUCT OF TAIWAN, individual pieces are held within clear plastic vacuum-sealed packaging. PRODUCTION DATE: 2015/05/19 BEST BEFORE DATE: 2017/05/19 Class III Recent FDA analysis determined that the product is decomposed and was also identified as Spanish mackerel. President East Company
Devices Philips Healthcare IntelliVue Info Center iX, A.0 866023 Software A.0.X Class II Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads. Philips Electronics North America Corporation
Devices Philips Healthcare PIIC Classic Upgrade, 866117 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm) Software B.O Class II Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads. Philips Electronics North America Corporation
Devices Philips Healthcare IntelliVue Info Center iX, B.0, 866389 Physiological, Patient Monitor (With Arrhythmia Detection or Alarm) Software Versions: B.0.X Class II Reconstructed ECG leads viewed or printed at the Information Center iX may misrepresent the ECG waveform in specific leads. Philips Electronics North America Corporation
Food Simply Roundy's Natural Authentic Italian Butternut Squash Ravioli, Net Wt. 9 oz (255g). Packaged in a paper tray inside a plastic bag and wrapped around with paper band. Made in Italy. UPC 11150-50750 Lot Numbers: 506B, 508C, 511D, 512C, 513B, 516B, 520A, 522B, 522F, 523B, 523C, 529C, 530F, 531F, 535C, and 536A Class I Roundy's is recalling Simply Roundy's Natural Authentic Italian Sweet Butternut Squash Ravioli because the product may contain undeclared cashew and almond. This product was manufactured and recalled by Bertagni 1882 SpA of Arcugnano, Italy due to undeclared cashews and almonds. Roundys Supermarkets, Inc.
Devices 9131-001 Defibrillation Electrodes, Lot No. 141125-02 Used in Powerheart G3 9300A, 9300E, 9300P, 9390A, and 9390E AEDs Cardiac Science 9131 Defibrillation Electrodes are single use and intended to be used in conjunction with Cardiac Science automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended for short term use (<8 hours) and must be used before the expiration date listed on the packaging. The AED electrodes are used for emergency treatment of cardiac arrest patients over 8 years of age or greater than 55 pounds. The user assesses the patient s condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin. Lot No. 141125-02 Class II Defibrillation electrodes may exhibit higher than expected electrical impedance over time. If electrode impedance becomes too high, your Powerheart G3 Automatic External Defibrillator (AED) will fail the electrode self-test and it will not be Rescue Ready. If the AED fails the self-test, the STATUS INDICATOR on the AED will be RED and the AED will beep. This is normal and correct behavior when the impedance limit is exceeded. The high impedance electrodes require replacement. Cardiac Science Corporation
Devices WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of steam Soft touch facial & nasal masks" Product labeling reads in part: "Well at Walgreens***WARM Helps relieve symptoms of stuffy nasal passages, congestion or scratchy throats due to cold, flu or allergies Model: PJ1011 Item: 366596 UPC code: 31191717008 Lot No. 08/14: 45228pcs Lot No. 12/14: 21096pcs Lot No. 01/15: 14220pcs Lot No. 03/15: 20040pcs Class II "The public reason for the recall is that the product is being recalled out of an abundance of caution due to one or more consumer complaints, which have been independently investigated and remain unconfirmed. No causal connection between the complaints and the producta¬"s proper use as instructed have been determined." Bigwall Enterprises
Food Great Pacific Bagel & Cream Cheese, product is wrapped with flexible clear plastic, net weight 4.5 oz. The UPC is UPC 92438 00300 all best by dates prior to 12/23/2015. Class II Great Pacific Bagel & Cream Cheese was recalled due to undeclared wheat Vern's & Son Food Service Distributing
Biologics Apheresis Platelets, Leukocytes Reduced W036815310964-part 1; W036815310964- part 2 Class II Blood products, which did not meet acceptable product specifications, were distributed. OneBlood, Inc.
Biologics Apheresis Platelets, Leukocytes Reduced W036814155275 Class II Blood product, which did not meet acceptable product specifications, was distributed. OneBlood, Inc.
Devices PRN 50-M+, GE part number 2062759-001, manufacturer part number 600-23310-01 Product Usage: The PRN 50M+ Paper Chart Recorder thermally records patient data on a paper strip. This device is intended for use under direct supervision of a licensed health care practitioner. This device is not intended for home use. Serial Number range: 1801405 through 1918761 Class II The item was recalled due to an increased user/patient risk of exposure to fire and/or electrical shock due to the failure of the PRN 50-M+ Digital Writer Gsi Group Inc
Biologics Apheresis Platelets, Leukocytes Reduced, Irradiated W050915058626; W050915053498; W050915053408 Class II Blood products, which did not meet acceptable product specifications, were distributed. HCSC-Blood Center
Biologics Apheresis Platelets, Leukocytes Reduced W050915058630; W050915058630; W050915058939; W050915058939; W050915058938; W050915058938; W050915053497; W050915053497; W050915056257; W050915058947; W050915058944; W050915058944; W050915056265; W050915056265; W050915053408; W050915053412; W050915056240; W050915056240 Class II Blood products, which did not meet acceptable product specifications, were distributed. HCSC-Blood Center
Biologics Apheresis Platelets, Leukocytes Reduced, Irradiated W115115230331I; W1151152539084 Class II Blood products, in which NAT testing was performed incorrectly, were distributed. LifeSouth Community Blood Centers, Inc.
Biologics Apheresis Red Blood Cells, Leukocytes Reduced W115115278374-part 1; W115115278374-part 2 Class II Blood products, in which NAT testing was performed incorrectly, were distributed. LifeSouth Community Blood Centers, Inc.
Biologics Red Blood Cells W1151152734529; W1151152734545; W1151152734553; W1151152734713; W115115289769O; W1151152935379 Class II Blood products, in which NAT testing was performed incorrectly, were distributed. LifeSouth Community Blood Centers, Inc.
Biologics Fresh Frozen Plasma W1151152734529; W1151152734553; W115115299009Z Class II Blood products, in which NAT testing was performed incorrectly, were distributed. LifeSouth Community Blood Centers, Inc.
Biologics Apheresis Platelets, Leukocytes Reduced W115115230331I; W1151152499294-part 1; W1151152499294-part 2; W115115251300Q-part 1; W115115251300Q- part 2; W115115269743Y-part 1; W115115269743Y-part 2; W1151152990160- part 1; W1151152990160-part 2; W115115302083I-part 1; W115115302083I-part 2; W1151153020896; W115115302893O-part 1; W115115302893O-part 2; W115115306031F-part 1; W115115306031F-part 2; W115115308091X Class II Blood products, in which NAT testing was performed incorrectly, were distributed. LifeSouth Community Blood Centers, Inc.
Biologics Red Blood Cells, Leukocytes Reduced W115115179244U; W1151152762001; W1151152778856; W1151152783707; W115115285076Z; W115115285295D; W115115291023J; W115115311197J Class II Blood products, in which NAT testing was performed incorrectly, were distributed. LifeSouth Community Blood Centers, Inc.
Biologics Red Blood Cells, Leukocytes Reduced W036215409255 Class II Blood product, labeled RBC antigen negative tested RBC antigen positive, was distributed. Exempla Saint Joseph Hospital
Biologics Apheresis Red Blood Cells, Leukocytes Reduced W035213335087H-part 1; W035213335087H-part 2 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Carter BloodCare
Devices Syngo Plaza Picture archiving and communication system. Software only. PACS intended to display, process, read, report, communicate, distribute, store and archive digital medical images. Stores and archives within DICOM structured reports. Integrates hospital/radiology information systems. Device model numbers: 10863171, 10863172, 10863173 Class II Siemens is releasing an updated software version to address several software issues including RGB images will show "?" since calculation of HU is not possible; save as option enabled; changes in access for loading studies; breast region is now properly fitted to segment boundary when clicking fit breast to screen. Siemens Medical Solutions USA, Inc
Devices Stryker Vitallium Wire (6 Pack) Non Sterile. For use in bone procedures. All lots of the following Catalog Numbers: 2704-1-024; 2704-3-018; 6703-1-018; 6703-2-120; 6704-1-018; 6704-2-120 and 6704-3-120. Class II The wire packages are correctly marked with a "NON-STERILE" label, however, the enclosed Instructions For Use (IFU) states the device are sterilized via gamma irradiation and should not be resterilized. Since the IFU states the devices are sterile, no instructions for moist heat sterilization are provided. Stryker Howmedica Osteonics Corp.
Biologics Red Blood Cells, Leukocytes Reduced W043215085630 Class II Blood product collected from a donor whose suitability to donate was not adequately determined, was distributed. Blood Assurance Inc
Biologics Blood and Blood Products for Reprocessing W041214048548P Class III Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed Blood Systems, Inc. dba United Blood Services Texas
Biologics Apheresis Platelets, Leukocytes Reduced W115115296332O Class II Blood product, with a low pH, was distributed. Lifesouth Community Blood Centers - Montgomery Region
Devices Single Lumen Central Venous Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH. RPN/Catalog number: C-PMS-250-PED C-PMS-251J-PED C-PMS-300-CHILDRENS-032285 C-PMS-301J-PED C-PMS-301J-PED-BH C-PMS-301-PED C-PMSY-250 C-PMSY-251 C-PMSY-251J C-PMSY-300 C-PMSY-300J C-PMSY-300J-UT-A C-PMSY-300-PED C-PMSY-301J C-PMSY-301J-BH C-PMSY-301J-PED C-PMSY-301J-PED-OTP C-PMSY-400-HURLEY-022388 C-PUM-300J C-PUM-301 C-PUM-301J C-PUMY-301J Lots: NS6168054 NS6178118 NS6063352 NS5855441 5824486 5898058 5967405 6079119 NS5932737 NS6028554 NS6042799 NS5922707 NS5932811 NS6145002 5987014 NS6178099 NS6028540 NS5830758 NS5866960 NS5918174 NS5974263 NS6042577 NS6047450 NS6090278 NS6105922 NS6124990 NS5881337 NS5892116 NS6031991 5782006 5855241 NS5881336 NS5892113 NS5945282 6062729 NS5970950 NS6108255 NS6153173 5793198 5925744 6010406 6148800 NS5796483 NS5928602 NS6047451 NS5970942 NS5954223 5945120 NS5954224 5973354 Class I A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids. Cook Inc.
Devices Single Lumen Pressure Monitoring Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH. RPN/Catalog number: C-PMS-250 C-PMS-2502-15-3.5 C-PMS-2502-15-5.0 C-PMS-250-MONTES-A-092084 C-PMS-251 C-PMS-251J C-PMS-300 C-PMS-300-CHILDRENS-A-032988 C-PMS-300J C-PMS-301 C-PMS-301J C-PMS-301J-PKG C-PMS-400J Lots: 6028502 6034979 6083984 6194848 NS6014456 NS6014457 6148788 6254047 5906417 6160213 NS6064797 NS6014483 NS6175149 NS6184593 NS6187516 NS6014458 5889463 5898283 5922849 5941909 5964565 5976506 6021072 6028497 6143834 6160238 NS5933957 5828147 5941919 NS5932835 NS5932836 NS6050233 NS6072523 NS6108227 NS6130497 5803601 6034985 6075213 NS5833882 NS5892109 NS5892110 NS5919920 NS6021136 NS6054843 NS6072524 NS6075557 NS6082375 NS6108228 NS6148658 6067668 Class I A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids. Cook Inc.
Devices Femoral Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH. RPN/Catalog number: C-NPMS-501J-15 C-NPMSY-501J-15 C-PMS-300-FA C-PMS-300J-FA C-PMS-301-FA C-PMS-301J-FA C-PMS-400-FA C-PMS-401-FA C-PMS-401J-FA C-PMSY-300-FA C-PMSY-300J-FA C-PMSY-400J-FA C-PMSY-401-FA Lots: 6054830 6054831 6072436 6078670 6081720 6083977 NS6054841 NS6054842 NS6075552 NS6082372 NS6082373 NS5833881 NS5881267 NS5881268 NS5892106 NS5892107 NS5892108 NS5914766 NS5922706 NS5928596 NS5932820 NS5932821 NS5967447 NS5967448 NS5967449 NS6014474 NS6014475 NS6014484 NS6014485 NS6042778 NS6042795 NS6042796 NS6050046 NS6063330 NS6063354 NS6075555 NS6100599 NS6100600 NS6108225 NS6124985 NS5888542 NS5928597 NS6028553 NS6042797 NS6090273 NS6090274 NS6100601 NS6130149 5800570 5860387 5891906 5980254 6003160 6062725 6143835 NS5830771 NS5866956 NS5866957 NS5881269 NS6014460 NS6042798 NS6050047 NS6075534 NS6075556 5895598 6129058 6148613 NS5932822 NS5932837 NS5994907 NS6130498 6067782 6139280 NS6042805 NS6130500 6049951 6137353 6139281 6034986 6049957 6067784 NS5833887 NS5866959 NS5881272 NS5881334 NS5881335 NS5919925 NS6047449 NS6054847 NS6054848 NS6072526 NS6072555 NS6082379 NS6090277 NS6105921 NS6124989 NS6130501 NS6148639 NS5866961 NS5866962 NS5892115 NS5922709 NS5932844 NS5974256 NS6031988 NS6031990 NS6042578 NS6050052 NS6050053 NS6031992 NS6031993 NS6130504 NS6137424 NS6054849 Class I A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids. Cook Inc.
Devices Radial Artery Pressure Monitoring Catheter Sets and Trays The subject sets and trays are comprised of a single-lumen uncoated or heparin-coated catheter. Product catalog numbers with heparin coating are designated by the suffix BH. RPN/Catalog number: C-PMS-250-RA C-PMS-251-RA C-PMS-300-RA C-PMS-300-RA-CHOP C-PMS-301J-RA C-PMS-301-RA C-PMS-400-RA C-PMSY-250-RA C-PMSY-300-RA C-PMSY-301-RA Lots: 6049998 6160195 6160212 NS5898558 NS6063328 NS6178204 NS6178206 5895605 6191185 5793196 5800313 5800443 5800569 5806981 5810905 5810917 5824484 5824546 5824547 5824548 5866984 5866985 5866986 5870319 5881447 5881519 5889496 5891905 5911486 5922847 5922848 5925742 5928632 5939446 5939447 5939448 5976502 6025016 6025094 6033768 6034981 6034983 6050000 6062738 6062742 6067675 6067676 6075206 6075207 6083936 6083954 6083985 6083986 6129056 6148790 6160236 6165591 6174974 6175289 6191362 6269150 NS6063331 NS6108226 NS6170739 NS6170767 5905252 6003109 NS6072553 5793197 5800571 5800572 5824485 5824551 5845063 5864072 5866988 5873125 5881151 5881152 5884641 5884642 5889464 5892063 5892064 5922850 5939431 5942091 5951549 5953768 5954322 5967404 5974281 5994817 5996926 6003161 6003162 6017048 6025095 6025145 6034984 6042699 6050002 6075210 6075211 6075212 6081723 6083988 6100756 6124809 6125111 6148791 6153122 6160239 6160240 6168131 6171368 6187477 6250532 6059759 NS6047396 NS6047397 NS6047398 NS6047399 NS6047440 NS6047442 6124812 5793192 5824526 5884647 5892068 5942090 5967410 6003167 6059765 6134128 6153124 6168137 6254068 5793193 5866995 5892069 5942092 6003168 6025099 6067664 6168138 Class I A manufacturing process may lead to catheter tip fracture and or separation. Potential adverse events may include loss of device function, medical intervention to retrieve a separated segment, or complications resulting from a separated tip occluding blood flow to end organs. These catheters are used in venous or arterial pressure monitoring, blood sampling, and administration of drugs and fluids. Cook Inc.
Biologics Apheresis Platelets, Leukocytes Reduced W115915014061 (triple collection) Class II Apheresis products, in which leuko reduced units did not meet WBC count specification, were distributed. Central California Blood Center
Devices Fresenius Naturalyte Liquid Acid Concentrate Catalog Number: 08-2301-3 Intended Use: Acid Concentrate for Bicarbonate Dialysis Lot Number: 15STAC072 Exp Date: 2017-12-31 Class II On the label calcium (Ca) listed in the right upper corner of the label (red background) incorrectly indicates the product contains 2.5 mEq/L Ca. The concentration indicated in the list of constituents represents the actual calcium concentration of the final dialysate, 3.0 mEq/L. Fresenius Medical Care Renal Therapies Group, LLC
Devices Olympus, Model No. PCF-H180AL, flexible scope, large diameter, video pediatric colonoscope Serial Numbers: 2005030,2800270,2007268,2802306,2802294,2108696,2801707,2006928,2201349,2904573, 2108936,2006513,2107568,2801235,2800468,2200301,2006896,2802237,2802245,2109496, 2109225,2006520,2200358,2200372,2200370,2200350,2200356,2200364,2200351,2200345, 2005915,2109239,2109237,2904265,2108385,2100007,2904378,2801427,2200930,2107811, 2700057,2004864,2004924,2800273,2109999,2100088,2301603,2107560,2200701,2200648, 2904362,2802353,2802234,2801828,2801792,2903393,2903491,2109241,2109087,2109090, 2201179,2109261,2109234,2802808,2801887,2801892,2007452,2801960,2006598,2903718, 2007242,2007253,2903751,2006554,2006560,2802465,2007275,2004893,2802541,2903876, 2903913,2200971,2700124,2904046,2904425,2007142,2802500,2904240,2109319,2800517, 2802466,2802455,2200168,2006418,2200172,2006479,2108689,2201411,2201402,2005274, 2005123,2005141,2201410,2201389,2903348,2800505,2006883,2801725,2200481,2903648, 2903632,2108188,2108969,2109228,2109233,2802031,2802017,2802028,2802016,2802029, 2108350,2108320,2801583,2903806,2904150,2007033,2903029,2802758,2802794,2802793, 2005497,2005545,2700076,2903964,2903965,2903969,2201427,2100108,2007401,2802654, 2005642,2802394,2903060,2903059,2903756,2200703,2200988,2201112,2903499,2904701, 2802756,2005665,2800338,2108452,2100110,2201023,2301893,2301911,2904358,2904345, 2904344,2904356,2904336,2802111,2005706,2005255,2200750,2200766,2200880,2200769, 2200774,2005599,2802920,2006131,2006639,2006641,2006642,2006638,2006640,2006632, 2006628,2006635,2006634,2903927,2005006,2904212,2903346,2802333,2904016,2903343 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. GIF-H180, flexible scope, large diameter, video gastroscope Serial Numbers: 2003035,2704738,2704724,2809007,2808939,2105965,2808765,2004365,2004669,2902353, 2902347,2902342,2004663,2602122,2105267,2601317,2806231,2805648,2808714,2807053, 2807205,2705548,2806959,2704571,2704560,2704611,2705574,2805740,2004809,2703149, 2601037,2901878,2702879,2702870,2703000,2704441,2902854,2003990,2003988,2705078, 2004004,2702967,2808478,2809057,2601256,2601255,2808955,2808944,2807181,2809202, 2206863,2900222,2900226,2900745,2901670,2900229,2003063,2902820,2002897,2600226, 2602014,2003460,2900362,2900112,2806936,2003147,270517S,2704934,2909893,2909872, 2909863,2901323,2806640,2704259,2106188,2106273,2601745,2704573,2003712,2807584, 2807557,2807713,2106293,2106290,2106303,2106300,2807679,2704771,2704770,2704792, 2704800,2602187,2704885,2808319,2602175,2808317,2602190,2702863,2808937,2809103, 2901274,2002984,2002916,2901389,2901374,2601611,2805999,2004421,2704766,2703778, 2705367,2795393,2805917,2805916,2809093,2902295,2004720,2902215,2809055,2004871, 2705449,2809016,2809050,2808936,2808938,2805816,2809044,2900211,2901687,2601179, 2602413,2704897,2705037,2808546,2808581,2808537,2808530,2004462,2004461,2004458, 2004457,2004452,2900338,2806650,2900337,2704236,2704202,2806696,2902604,2703089, 2601468,2004949,2702732,2602089,2808410,2808402,2808413,2808391,2808412,2808415, 2808405,2808379,2807126,2705106,2805727,2702820,2705110,2702954,2704316,2103301, 2901080,2901329,2901326,2900094,2807461,2807463,2600468,2600432,2600183,2003532, 2602342,2901759,2901798,2901789,2901786,2004023,2004047,2601355,2206691,2807571, 2601721,2900252,2808516,2809385,2809049,2809068,2809056,2809060,2806692,2806772, 2702822,2807586,2703753,2106008,2902452,2704036,2601438,2703138,2601515,2703127, 2703134,2105807,2806871,2806863,2003144,2902409,2806880,2809409,2703670,2900905, 2900885,2900901,2900907,2900902,2900892,2902465,2105610,2600472,2602482,2004043, 2909906,2808548,2602237,2901669,2900507,2705345,2703372,2600645,2003099,2807855, 2806888,2807784,2807852,2704075,2900761,2806646,2900595,2809208,2902564,2600735, 2003799,2601893,2602481,2003728,2003726,2900894,2808085,2808064,2808060,2900874, 2003167,2105243,2909945,2601918,2809264,2909796,2909798,2004189,2704407,2901872, 2808189,2808188,2600417 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. CF-H180AL, flexible scope, large diameter, video colonoscope Serial Numbers: 2601800,2807942,2104002,2807968,2003519,2003522,2003506,2003533,2003517,2807849, 2807869,2106004,2001560,2602147,2806411,2900360,2001561,2602228,2602229,2309559, 2309556,2602230,2805615,2103724,2103717,2002975,2805586,2806264,2806591,2705038, 2908746,2808043,2704335,2705017,2002983,2106012,2105987,2106009,2106019,2002580, 2002571,2104510,2002603,2900105,2001677,2105162,2909901,2703303,2909972,2601007, 2601084,2104893,2704419,2806374,2806356,2104903,2908799,2601095,2807327,2640009, 2702843,2207664,2207660,2702782,2106428,2806318,2908674,2702730,2704143,2703560, 2106031,2908845,2908846,2908841,2908838,2908852,2908837,2908840,2908843,2106106, 2601525,2807589,2808233,2309810,2805782,2909109,2601535,2104776,2104781,2806163, 2908908,2103829,2104924,2002427,2909718,2002323,2703941,2601588,2601200,2600263, 2309366,2602033,2602034,2900148,2106202,2003379,2000851,2003280,2106797,2003653, 2106800,2807548,2106791,2909657,2003008,2003228,2003232,2106134,2808000,2900241, 2900656,2000774,2106423,2003189,2106410,2309513,2900683,2106413,2807888,2309493, 2106264,2106409,2106422,2107166,2909809,2107149,2808271,2702536,2702344,2704544, 2704568,2704587,2703158,2104281,2703144,2602024,2002832,2805717,2002833,2600272, 2704020,2001762,2207531,2900586,2003128,2208594,2002620,2309683,2001688,2104750, 2104891,2309573,2000881,2309635,2001645,2001650,2106010,2104981,2104993,2104937, 2104890,2900413,2703200,2601190,2309828,2909966,2601218,2001712,2601205,2806343, 2704399,2704716,2105584,2105562,2105559,2104847,2601672,2601642,2602223,2808051, 2703078,2002521,2601938,2601866,2908548,2908499,2105744,2909315,2105988,2106017, 2309497,2309262,2104662,2806423,2105002,2105542,2001423,2309783,2703663,2703654, 2001547,2600215,2001708,2001468,2001514,2001519,2309845,2001311,2309105,2208046, 2208058,2806987,2704187,2208651,2309470,2003116,2003086,2003104,2208215,2001850, 2805888,2309542 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. GIF-160, flexible scope, large diameter, video gastroscope Serial Numbers: 2203925,2001221,2205721,2102757,2102758,2000420,2419219,2001053,2001248,2001285, 2103701,2307844,2408213,2419900,2419587,2419391,2307188,2408135,2408138,2205035, 2205321,2306154,2103419,2000710,2408319,2103515,2204385,2204384,2510491,2419538, 2001154,2103711,2101909,2306353,2103416,2000041,2103345,2408554,2408663,2307057, 2103617,2419115,2306153,2205297,2205019,2306510,2419520,2000431,2408693,2205441, 2419920,2204907,2102886,2102877,2306758,2306495,2000590,2510424,2205820,2307047, 2307014,2307030,2307052,2307066,2306132,2204209,2204663,2204110,2419379,2205371, 2205380,2205384,2408566,2204782,2103708,2101363,2419549,2001300,2103162,2103161, 2510637,2419320,2204264,2204882,2408764,2408487,2419319,2510526,2204325,2419745, 2204606,2103269,2102524,2419255,2419198,2204551,2000906,2307366,2307304,2103274, 2510151,2419258,2102792,2307251,2102786,2307350,2419462,2407416,2306959,2306800, 2307470 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. GIF-H180J, flexible scope, large diameter, video gastroscope Serial Numbers: 2102433,2102439,2102434,2002026,2002023,2000101,2000567,2001703,2317892,2001252, 2103738,2206336,2001183,2317780,2317782,2001658,2002113,2002108,2001058,2205716, 2103267,2206418,2104707,2104698,2000541,2001445,2000352,2104483,2104215,2001040, 2104379,2104209,2103329,2103015,2104488,2102974,2206175,2001272,2001664,2001241, 2317793,2105371,2001462,2418248,2418397,2105032,2418202,2001127,2001130,2206216, 2104357,2104490,2103447,2205654,2103446,2103440,2205664,2001504,2001507,2104514, 2001451,2104498,2104528,2104474,2001880,2001877,2104733,2104747,2104736,2104746, 2206304,2001661,2001630,2001629,2001626,2001641,2104502,2206298,2104780,2104768, 2104772,2317557,2001884,2317515,2104773,2105392,2205478,2105396,2205463,2205479, 2102775,2217033,2217029,2217036,2104347,2002170,2206318,2317401,2317975,2103228, 2317752,2216831,2317699,2317693,2317691,2103700,2103695,2104487,2104491,2103098, 2103009,2103295,2104653,2317589,2104541,2002004,2002001,2104533,2001862,2103606, 2103935,2104349,2000395,2103657,2317957,2000953,2206569,2103744,2217195,2002120, 2317577,2104489,2103049,2317690,2103060,2317683,2317684,2103375,2000500,2216960, 2000389,2000634,2105256,2105255,2105150,2317905,2317875,2103770,2103557,2103574, 2216820,2217126,2217122,2206257,2206237,2206196,2206239,2206200,2206049,2001713, 2206052,2206240,2001536,2317519,2216863,2102463,2102459,2102464,2102474,2001783, 2001781,2001788,2001747,2001770,2001778,2001756,2001755,2001785,2105103,2001731 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. GIF-Q180,flexible scope, large diameter, video gastroscope Serial Numbers: 2501321,2603572,2603751,2707414,2500011,2705546,2604232,2603079,2500780,2808458, 2001720,2002054,2001724,2001723,2501905,2809593,2705417,2500916,2808421,2809413, 2705911,2203846,2808998,2501295,2809000,2705264,2603152,2809444,2706645,2102694, 2203503,2809061,2705453,2706361,2102880,2002142,2500236,2705566,2705242,2500869, 2501511,2603466,2706515,2706908,2706905,2706442,2001193,2501087,2501807,2705697, 2705333,2900664,2501186,2800014,2707065,2705978,2501786,2002139,2002083,2809935, 2809951,2707769,2304352,2707593,2304332,2001807,2808518,2602866,2602846,2706687, 2001864,2808509,2705957,2706072,2705888,2602226,2102504,2501901,2501941,2900354, 2501928,2203680,2500463,2203472,2707126,2603744,2707886,2901047,2603180,2604176, 2707760,2502049,2602102,2706079,2706071,2603287,2602732,2602730,2900859,2705386, 2808456,2705662,2809750,2705605,2705589,2808232,2706404,2500529,2602714,2501738, 2706823,2809590,2604997,2604999,2604989,2808704,2808713,2604264,2706028,2800064, 2808452,2500660,2501776,2808455,2501961,2501854,2809540,2501472,2602442,2603316, 2808333,2707097,2706919,2707574,2501001,2706156,2605035,2501890,2603001,2603053, 2706604,2707840,2501962,2605156,2808499,2304527,2603134,2604932,2102468,2500067, 2501704,2501595,2603135,2705891,2807973,2705461,2603530,2707882,2706068,2807964, 2706013,2705465,2707101,2705475,2707892,2500032,2602610,2501680,2707346,2707374, 2707382,2500458,2500653,2808341,2808894,2603444,2001317,2602502,2604160,2500576, 2706920,2808353,2705694,2705593,2900826,2900764,2604623,2901059 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. GIF-XP160, flexible scope, large diameter, video gastroscope Serial Numbers: 2000023,2110370,2211004,2210975,2110666,2110583,2411739,22109S9,2311220,2812668, 2311177,2110498,2411568,2110745,2110711,2000181,2211040,2812506,2110504, 2311372,2012921 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. CF-Q180AL, flexible scope, large diameter, video colonoscope Serial Numbers: 2807123,2706168,2704697,2704696,2706205,2603823,2500832,2806683,2706253, 2706256,2704313,2704314,2008421,2602202,2602873,2806818,2704323,2603826, 2806676,2807264,2603013,2602S15,2501708,2806563,2501622,2602650,2501251, 2704932,2501637,2705315,2208812,2603725,2806595,2601980,2500885,2603935, 2705615,2705705,2705305,2500522,2907865,2705498,2603941,2807163,2807143, 2501819,2704886,2501553,2501744,2501768,2603178,2603044,2704755,2501372, 2807593,2705425,2208838,2208833,2706176,2008309,2704655,2705847,2706206, 2603321,2705005,2501169,2704832,2704839,2602446,2806333,2705983,2500287, 2601941,2501912,2604229,2501770,2806741,2806744,2603057,2704336,2806592, 2500217 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. PCF-160AL, flexible scope, large diameter, video colonoscope Serial Numbers: 2123053,2337714,2338700,2337727,2112612 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. CF-Q160L, flexible scope, large diameter, video colonoscope Serial Numbers: 2000158, 2203109,2000413,2101113,2304140,2203874,2405424,2203295,2203853, 2517622,2101047,2102290,2102302,2102305,2102303,2203697,2102317,2102297, 2202898,2203059,2203471,2304922,2202617,2416261,2102141,2101633 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. GIF-Q140, flexible scope, large diameter, video gastroscope Serial Numbers: 2813102,2914792,2711389,2711291,2812266,2812356,2802476,2600371,2914632, 2914333 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. GIF-140, flexible scope, large diameter, video gastroscope Serial Numbers: 2801185,2801376,2700216,2903833,2903851,2700830,2801154,2700481,2700049, 2025259,2802540,2700325 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. PCF-Q180AL, flexible scope, large diameter, video colonoscope Serial Numbers:2707306,2705876,2807674,2706579,2009538,2706717,2604531,2706710,2501499, 2808113,2705777,2705730,2707016,2808779,2808777,2707125,2603799,2603795, 2603779,2603825,2604265,2807420,2604568,2501361,2500180,2602289,2909274, 2808355,2808217,2808957,2808020,2602290,2707346,2707406,2808556,2807468, 2603295,2604460,2705711,2009462,2602564,2501493,2808528,2500150,2603952, 2603243,2807523,2500982,2500983,2706852,2706892,2009425,2500420,2501392, 2603200,2807685,2501550,2501315,2706332,2604191,2604217,2706407,2603757, 2603028,2603031,2501324,2300253,2300252,2603975,2704883,2603976,2807640, 2808342,2707351,2602872,2808599,2706811,2707210,2500216,2501543,2808299, 2808816,2100010,2807695,2009697,2500686,2604024,2705191,2808911,2808139, 2602993,2705168,2500369,2500602,2501796,2705522,2009502,2808909,2808836, 2601829,2601832,2807758,2707152,2808449,2501699,2601820,2501213,2200069, 2808356,2704854,2704864,2603401,2704735,2603647,2705203,2808490,2501463, 2602027,2705832,2501166,2603137,2603106 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. CF-Q160AL, flexible scope, large diameter, video colonoscope Serial Numbers: 2427253,2528563,2315445,2314847,2212887,2315826,2000027,2314864,2315955, 2213834,2212872,2315727,2315729,2213866,2416648,2427952,2416195,2314929, 2111326,2416125,2213186,2111744,2315611,2213344,2314241,2427731,2427747, 2314885,2314876,2314596,2010689,2314038,2315864,2010526,2315138,2315140, 2315540,2111669,2212839,2212640,2427816,2314895,2427562 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. CF-140L, flexible scope, large diameter, video colonoscope Serial Numbers: 2127866,2712435,2914674,2026893,2916216,2813792,2228261,2711888,2600329 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. GIF-Q160, flexible scope, large diameter, video gastroscope Serial Numbers: 2407409,2407584,2306291,2204284,2305898,2406901,2306874,2000549,2203971, 2407393,2203790,2000405,2306456,2102668,2203672,2406988,2102128,2103100, 2103035,2204108,2204527,2000464,2204116,2102323,2417865,2102954,2519556, 2418512,2306371,2305350,2407684,2519174,2519207,2519210,2102734,2205217, 2001322,2418634,2406987,2418156,2305446,2204190,2204202,2103307,2101785, 2518969,2519343,2102896,2203946,2001430,2305568,2102316,2305870,2204258 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. TJF-160F, flexible scope, large diameter, video duodenoscope Serial Numbers: 2201503,2000062,2000105,2100621,2301997,2100999,2201555,2302025,2000061, 2201491,2000039,2100930,2402518,2302084,2100852,2101121 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. GIF-XQ140, flexible scope, large diameter, video gastroscope Serial Numbers: 2600297,2601232,2600397,2013906 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. PCF-140L, flexible scope, large diameter, video colonoscope Serial Numbers: 2700328,2912416,2811408 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. PCF-H190L, flexible scope, large diameter, video pediatric colonoscope Serial Number 2303917 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. CF-Q140L, flexible scope, large diameter, video colonoscope Serial Numbers: 2913081,2600279 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices Olympus, Model No. XCF-Q160ALE, flexible scope, large diameter, video colonoscope Serial Number 240T024 Class II If excessive pressure is applied to the distal end of the endoscope, the internal coil pipe assembly at the distal end of the endoscope can become detached and angulation may not operate as intended. Integrated Medical Systems Inc
Devices This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system. Product Code/Name: PA0552 (All Lots) Bond Ready-to-Use Primary Antibody PAX-5 (1EW). Detection Kit: DS9800 BondTM Polymer Refine Detection Kit. Affected Detection Kit Lots: 42314, 42388, 42474, 42486, 42499, 42555, 42570, 42579, 42627, 42645, 42683, 42780, 42802, 42823, 42852, 43050. Class II The Bond" Polymer Refine Detection and Novolink" Polymer Detection System may not provide adequate staining when using a detection protocol where one of its components - Peroxide Block / Peroxidase Block is applied after the primary marker incubation as specified in the Instructions for Use Following the Instructions for Use. Leica Microsystems, Inc.
Devices BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10454728 (BCS RECONDITIONED), 10454729 (BCS RECONDITIONED), 10454742 (BEHRING COAGULATION SYSTEM), 10459303 (BCS RECONDITIONED), 10460659 (BCS INSTRUMENT), 10461881 (BCS INSTRUMENT), IVD --- Device Listing D018966 All serial numbers Class II False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not flagged by the existing check algorithms. Siemens Healthcare Diagnostics, Inc.
Devices BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studies, Catalog Numbers: 10459330 (BCS XP SYSTEM, COMPLETE), 10462449 (BCS XP ANALYZER SYSTEM), 10461894 (BCS XP), 10470625 (BCS XP REFURBISHED); IVD --- Device Listing D060801 All serial numbers Class II False short clotting times for PT on BCS and BCS XP with Dade Innovin can occur. This has also an effect for false low PT INR values. These false short clotting times were observed only with turbid, hemolytic and/or icteric samples from intensive care patients. The corresponding reaction curves of these samples showed a pre-peak, which can lead to falsely short clotting time. The result was not flagged by the existing check algorithms. Siemens Healthcare Diagnostics, Inc.
Devices The Symbiq infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. It is intended primarily for use in the hospital setting and can be used in other acute and non-acute areas, such as, but not limited to, Nursing Homes, Mobile Intensive Care, Ambulatory Infusion, Centers, Hospice, Sub acute facilities, Outpatient/Surgical Centers, Long-term Care, Urgent Care, Transport, and Physician Offices. Lot Code 16026 &16027 with the following serial numbers: 14339221, 14339224, 14339232, 14339261, 14339275, 14339296, 14339308, 14339321, 14339335, 14339349, 14339353, 14339357, 14339371, 14339372, 14339378, 14339387, 14339391, 14339396, 14339401, 14339504, 14339515, 14339553, 14339710, 14339719, 14339725, 14339733, 14339738, 14339742, 14339748, 14339761, 14339769, 14339771, 14339799, 14339815, 14339822, 14339851, 14339887, 14339888, 14339904, 14339913, 14339964,  ...
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Class II Potential for the Symbiq pole clamp assemblies to be missing the rubber stop pad. Hospira Inc.
Biologics Red Blood Cells, Leukocytes Reduced W270112230651 Class II Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed. Central Pennsylvania Blood Bank
Food Izzie Macs! Macadamia Nuts - Salted. Certified Organic Macadamia Nuts, 100% Big Island Grown A raw food. Sold in 6 oz. plastic bag and 16 oz. plastic bag. UPC - 6 oz.: 689076792677; UPC 16 oz.: 689076792974. Mahina Mele Farm 87-2642 Mamalahoa Hwy. Captain Cook, HI 96704 All Lots currently in commerce Class I IEH sampling found samples of raw macadamia nuts to be positive for Salmonella. Mahina Mele Farm
Food Izzie Macs! Macadamia Nuts - Unsalted. Certified Organic Macadamia Nuts, 100% Big Island Grown A raw food. Sold in 6 oz. plastic bag and 16 oz. plastic bag. UPC - 6 oz.: 689076793575; UPC 16 oz.: 689076792776. Mahina Mele Farm 87-2642 Mamalahoa Hwy. Captain Cook, HI 96704 All lots currently is commerce Class I IEH sampling found samples of raw macadamia nuts to be positive for Salmonella. Mahina Mele Farm
Food Bulk Macadamia Nuts - (salted, unsalted; whole and pieces) Certified Organic Macadamia Nuts, 100% Big Island Grown A raw food. Sold in 5 lb. bag. NO UPC number. Mahina Mele Farm 87-2642 Mamalahoa Hwy. Captain Cook, HI 96704 All lots currently in commerce Class I IEH sampling found samples of raw macadamia nuts to be positive for Salmonella. Mahina Mele Farm
Food Baby Bruddah's Mac Nut Buttah; Certified Organic by International Certification Services Inc.. From the Big Island, A raw food. Sold in 12 oz. plastic tub. UPC number: 753182242019 Mahina Mele Farm 87-2642 Mamalahoa Hwy. Captain Cook, HI 96704 All lots currently in commerce Class I IEH sampling found samples of raw macadamia nuts to be positive for Salmonella. Mahina Mele Farm
Food Baby Bruddah's Chocolate Mac Nut Buttah; Certified Organic by International Certification Services Inc. From the Big Island, A raw food. Sold in 12 oz. plastic tub. UPC number: 75318224204 Mahina Mele Farm 87-2642 Mamalahoa Hwy. Captain Cook, HI 96704 All lots currently in commerce Class I IEH sampling found samples of raw macadamia nuts to be positive for Salmonella. Mahina Mele Farm
Devices CDI H/S Cuvette, non-sterile, Manufactured by Terumo Cardiovascular Group, Perfusion Pack or Smart Perfusion Pack. Product Usage: Heart/Lung Perfusion Pack is either a customized tubing pack built to user specifications or a stock tubing pack, designed for use during surgery requiring cardiopulmonary bypass. It is not designed for long-term use (greater than six hours). Perfusion Packs labeled as SMART® contain components that have an additive to improve blood compatibility. Non-SMART packs may contain some SMART tubing and/or connectors depending on the customer requirements. Catalog Number 6922, 1/2 inch -lots TE27, TH06 and TK03 Catalog Number 6923, 3/8 inch - lots TE13, TE18, TG15, TH20 and TK17 b. Model Number(s): 020204612, 020208807, 020210805, 020211806, 020493806, 044002300, 044003200, 044004102, 044004700, 044010200, 044016900, 044017601, 044018700, 044019901, 044027700, 044035101, 075104103, 075104404, 020135802, 088511700, 084103204, 047000500, 046001601, 065255600, 066110500, 075203800,  ...
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Class III The CDI System 500 monitor displays the "H/S DISCONNECT AT CUVETTE" error message when the CDI HIS Cuvette does not make a proper connection with the CDI H/S Probe. When this occurs, blood parameter values for HCT, Hgb and S02 do not display. Sorin Group USA, Inc.
Food Mary's Gone Crackers Thins, Light and Tasty Snack Crackers; Lightly salted. Organic, gluten free, non gmo, vegan; NET WT. 4.5 oz (127 g); UPC: 10897580000707; Mary's Gone Crackers, Inc. 199 Kentucky St., Gridley, CA 95948 Lot: 15120003; Best By: 09SEPT2016 A3433 Class II Gluten Free product may have gluten levels above the >20 ppm limit in FDA regulations for gluten free products. Mary's Gone Crackers, Inc.
Devices Flow-i Anesthesia System Product Usage: The indication for the Flow-i Anesthesia System is administering inhalation anesthesia while controlling the entire ventilation of patients with no ability to breath, as well as in supporting patients with a limited ability to breath. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment by healthcare professionals trained in inhalation anesthesia administration. Model numbers: C20, C30 and C40 (Only Model # C20 for US) Part numbers: 66 77 200 (US Only), 66 77 300 and 66 77 400 Serial numbers (2743, 2852, 2854, 2855, 2856, 2858 Class I Electrical issues in the control, monitoring or panel sub-systems, caused by the printed circuit boards (PCBs) that control the sub-systems. The problems manifested as multiple re-starts of the sub-systems and, in a few instances, disabling of the system has occurred. Replacement PCBs are now available to correct the issues. Only the Model C20 is affected in the US. Maquet Cardiovascular Us Sales, Llc
Devices Hill-Rom Bariatric Power Recliner, Product Model # P9096 Hill-Roms 660 lb Powered Bariatric Recliner was created to provide an aesthetically pleasing design that will enhance the overall experience for the bariatric patient. Using spring box construction and an exceptionally smooth mechanism, the patient is able to move into a reclined position with little effort and infinite positions up to 38 degrees. An independent footrest enables patients to be in a fully seated position with their feet up for added comfort. Bariatric Power Recliner, Product Model # P9096; all power bariatric chairs that are affected by this field action is distributed within the following serial number range: L341RW9151 through P070RW0812 Class II The recliners were shipped without the foot rest ottoman linkage side shields, which could result in consumer injury. Hill-Rom, Inc.
Devices Specify 5-6-5 Lead, Specify 2x8 Lead, Model Numbers: 39565, 39286. Spinal cord stimulation leads. Part of a neurostimulation system for treating chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain. All lot/serial numbers are affected for both Model numbers: 39565 and 39286 Class II Some Specify 5-6-5 and 2x8 surgical lead product labeling does not adequately distinguish between permanent surgical implant and trialing/screening use. Medtronic Neuromodulation
Devices LPS-FLEX GSF OPT prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer Various sizes  Product Usage "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " The CR-Flex GSF and LPS-Flex GSF uncoated (Option) and precoat styles are intended for cemented use only. " The CR-Flex GSF and LPS-Flex GSF porous coated femoral components may be used cemented or uncemented (biological fixation). " Specific uses with CR-Flex GSF or LPS-Flex GSF femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm Prolong® Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee Flex Congruent articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees." Item numbers: 00-5764-013-51 00-5764-013-52 00-5764-014-51 00-5764-014-52 00-5764-015-51 00-5764-015-52 00-5764-016-51 00-5764-016-52 00-5764-017-51 00-5764-017-52 Lots: 11003937 11004287 11004298 11004337 11004544 11004612 11004769 11004797 11004818 11005062 11005066 11005155 11005276 11005598 11005680 11005705 11005748 11005900 11005931 11005959 11005980 11006190 11006737 11006764 11006827 11006840 11006882 11006922 11006986 11007165 11007217 11007272 11007323 11007651 11007849 11007988 11008186  ...
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Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices NexGen CR-FLEX Option FEM NexGen CR-FLEX Precoat FEM NexGen CR-FLEX Porous FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " CR-Flex and LPS-Flex porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). CR-Flex HA/TCP porous coated femoral and tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only. " Specific uses with CR-Flex or LPS-Flex femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm Prolong® Highly Crosslinked Polyethylene CR articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees. " Specific Uses with NexGen LPS or LCCK femorals: The LPS femoral is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 130 degrees. The usage of the LCCK femoral is the same as the LPS with the exception that femoral bone loss can be accommodated by femoral stem extensions and augmentation. No varus/valgus constraint or other stability other than that provided by the NexGen LPS is provided when the LCCK femoral component is used with the LPS-Flex articular surfaces." Item numbers: 00-5950-012-01 00-5950-012-02 00-5950-013-01 00-5950-013-02 00-5950-013-05 00-5950-013-06 00-5950-014-01 00-5950-014-02 00-5950-014-05 00-5950-014-06 00-5950-015-01 00-5950-015-02 00-5950-015-05 00-5950-015-06 00-5950-016-01 00-5950-016-02 00-5950-016-05 00-5950-016-06 00-5950-017-01 00-5950-017-02 00-5950-017-05 00-5950-017-06 00-5952-012-01 00-5952-012-02 00-5952-013-01 00-5952-013-02 00-5952-013-05 00-5952-013-06 00-5952-014-01 00-5952-014-02 00-5952-014-05 00-5952-014-06 00-5952-015-01 00-5952-015-02 00-5952-015-05 00-5952-015-06 00-5952-016-01 00-5952-016-02 00-5952-016-05 00-5952-016-06 00-5952-017-01 00-5952-017-02 00-5952-017-05 00-5952-017-06 00-5956-012-01 00-5956-012-02 00-5956-013-01 00-5956-013-02  ...
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Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices NexGen LPS-FLEX Option Femoral NexGen LPS-FLEX Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Product Usage "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " CR-Flex and LPS-Flex porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). CR-Flex HA/TCP porous coated femoral and tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only. " Specific uses with CR-Flex or LPS-Flex femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm Prolong® Highly Crosslinked Polyethylene CR articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees. " Specific Uses with NexGen LPS or LCCK femorals: The LPS femoral is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 130 degrees. The usage of the LCCK femoral is the same as the LPS with the exception that femoral bone loss can be accommodated by femoral stem extensions and augmentation. No varus/valgus constraint or other stability other than that provided by the NexGen LPS is provided when the LCCK femoral component is used with the LPS-Flex articular surfaces." Item numbers: 00-5960-011-31 00-5960-011-32 00-5960-012-31 00-5960-012-32 00-5960-013-31 00-5960-013-32 00-5960-014-31 00-5960-014-32 00-5960-015-31 00-5960-015-32 00-5960-016-31 00-5960-016-32 00-5960-017-31 00-5960-017-32 00-5964-012-01 00-5964-012-02 00-5964-013-01 00-5964-013-02 00-5964-014-01 00-5964-014-02 00-5964-015-01 00-5964-015-02 00-5964-016-01 00-5964-016-02 00-5964-017-01 00-5964-017-02 Lot numbers: 11003819 11003822 11003824 11003955 11003973 11003997 11004030 11004042 11004076 11004086 11004103 11004104 11004105 11004160 11004166 11004173 11004174 11004188 11004190 11004223  ...
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Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " CR and LPS porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only." Item numbers: 00-5970-011-31 00-5970-011-32 00-5970-012-31 00-5970-012-32 00-5970-013-31 00-5970-013-32 00-5970-013-33 00-5970-013-34 00-5970-014-31 00-5970-014-32 00-5970-014-33 00-5970-014-34 00-5970-015-31 00-5970-015-32 00-5970-015-33 00-5970-015-34 00-5970-016-31 00-5970-016-32 00-5970-017-31 00-5970-017-32 00-5970-018-31 00-5970-018-32 00-5972-011-31 00-5972-011-32 00-5972-012-31 00-5972-012-32 00-5972-013-33 00-5972-013-34 00-5972-014-33 00-5972-014-34 00-5972-015-33 00-5972-015-34 00-5972-016-31 00-5972-016-32 00-5972-017-31 00-5972-017-32 00-5972-018-31 00-5972-018-32 Lot numbers: 11003380 11003415 11003477 11003574 11003583 11003586 11003597 11003601  ...
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Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Product Usage "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " CR and LPS porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only." Item numbers: 00-5992-017-91 00-5992-017-92 00-5994-013-01 00-5994-013-02 00-5994-013-91 00-5994-013-92 00-5994-014-01 00-5994-014-02 00-5994-014-91 00-5994-014-92 00-5994-015-01 00-5994-015-02 00-5994-015-91 00-5994-015-92 00-5994-016-01 00-5994-016-02 00-5994-016-91 00-5994-016-92 00-5994-017-01 00-5994-017-02 00-5994-017-91 00-5994-017-92 00-5996-011-01 00-5996-011-02 00-5996-011-51 00-5996-011-52 00-5996-012-01 00-5996-012-02 00-5996-012-51 00-5996-012-52 00-5996-013-01 00-5996-013-02 00-5996-013-51 00-5996-013-52 00-5996-014-01 00-5996-014-02 00-5996-014-51 00-5996-014-52 00-5996-015-01 00-5996-015-02 00-5996-015-51 00-5996-015-52 00-5996-016-01 00-5996-016-02 00-5996-016-51 00-5996-016-52 00-5996-017-01 00-5996-017-02  ...
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Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Porous Fem NexGen Knee LPS Precoat Fem prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " CR and LPS porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only." Item numbers: 00-5966-013-01 00-5966-013-02 00-5966-014-01 00-5966-014-02 00-5966-015-01 00-5966-015-02 00-5966-016-01 00-5966-016-02 00-5966-017-01 00-5966-017-02 00-5970-011-01 00-5970-011-02 00-5970-012-01 00-5970-012-02 00-5970-013-01 00-5970-013-02 00-5970-013-03 00-5970-013-04 00-5970-014-01 00-5970-014-02 00-5970-014-03 00-5970-014-04 00-5970-015-01 00-5970-015-02 00-5970-015-03 00-5970-015-04 00-5970-016-01 00-5970-016-02 00-5970-017-01 00-5970-017-02 00-5970-018-01 00-5970-018-02 00-5972-011-01 00-5972-011-02 00-5972-012-01 00-5972-012-02 00-5972-013-01 00-5972-013-02 00-5972-013-03 00-5972-013-04 00-5972-014-01 00-5972-014-02 00-5972-014-03 00-5972-014-04 00-5972-015-01 00-5972-015-02 00-5972-015-03 00-5972-015-04  ...
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Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices ZIMMER UNI HIGH FLEX PRECOAT FEM prosthesis, knee, femorotibial, non-constrained, cemented, metal/polymer various sizes These devices are indicated for patients with: - Painful and/or disabling knee joints due to osteoarthritis or traumatic arthritis. - Previous tibial condyle or plateau fractures with loss of anatomy or function. - Varus or valgus deformities. - Revision of previous arthroplasty procedures. " These devices are indicated for cemented use only. " The Zimmer Unicompartmental Knee System is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees." Item numbers: 00-5842-011-01 00-5842-011-02 00-5842-012-01 00-5842-012-02 00-5842-013-01 00-5842-013-02 00-5842-014-01 00-5842-014-02 00-5842-015-01 00-5842-015-02 00-5842-016-01 00-5842-016-02 00-5842-017-01 00-5842-017-02 Lot numbers: 11002504 11002764 11002766 11002767 11002780 11002782 11002784 11003009 11003028 11003042 11003048 11003345 11003366 11003367 11003370 11003371 11003384 11003398 11003399 11003413 11003414 11003433 11003452 11003488 11003490 11003491 11003584 11003587 11003588 11003589 11003603 11003611  ...
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Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices Gender PFJ FEMORAL COMP, prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes " Osteoarthritis, traumatic arthritis, polyarthritis, and/or severe chondrocalcinosis of the patellofemoral joint. The salvage of previously failed surgical attempts (e.g., arthroscopy, lateral release, cartilage transplantation). History of patellar dislocation or patella fracture. Dysplasia-induced degeneration. This device is intended for cemented use only." Item numbers: 00-5926-011-01 00-5926-011-02 00-5926-012-01 00-5926-012-02 00-5926-013-01 00-5926-013-02 00-5926-014-01 00-5926-014-02 00-5926-015-01 00-5926-015-02 Lot numbers: 11003385 11003487 11003827 11003957 11004055 11004100 11004102 11004106 11004145 11004378 11004444 11004449 11004454 11004464 11004499 11005712 11005779 11005783 11006058 11006623 11006851 11006878 11006925 11006973 11008245 11008259 11008270 11008331 11008381 61771793 61771795 61777453 61777454 61777455 61777456 61777457  ...
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Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural Knee GSM POR Flex prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). " Components without CSTi porous coating are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. " The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex, NexGen CR-Flex Mobile*, NexGen UC-Flex Mobile*, NexGen Trabecular Metal" CR Monoblock, 90-prefix NexGen CR, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong® Highly Crosslinked Polyethylene CR articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees." Item numbers: 00-5410-014-01 00-5410-014-02 00-5410-015-01 00-5410-015-02 00-5410-016-01 00-5410-016-02 00-5410-017-01 00-5410-017-02 00-5410-018-01 00-5410-018-02 00-5412-014-02 00-5412-015-01 00-5412-016-02 00-5414-013-01 00-5414-014-01 00-5414-014-02 00-5414-015-01 00-5414-015-02 00-5414-016-01 00-5414-016-02 00-5416-013-01 00-5416-013-02 00-5416-014-01 00-5416-014-02 00-5416-015-01 00-5416-015-02 00-5416-016-01 00-5416-016-02 00-5416-017-01 00-5416-017-02 00-5750-013-01 00-5750-013-02 00-5750-013-05 00-5750-013-06 00-5750-014-01 00-5750-014-02 00-5750-014-05 00-5750-014-06 00-5750-015-01 00-5750-015-02 00-5750-015-05 00-5750-015-06 00-5750-016-01 00-5750-016-02 00-5750-016-05 00-5750-016-06 00-5750-017-01 00-5750-017-02  ...
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Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices NKII CSTI Porous Femoral NKII NP Femoral prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer variou sizes Product Usage "" The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating is indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). " The Natural-Knee II primary components without CSTi Porous Coating, all posterior stabilized and revision components, the N-K II Constrained Knee System, the modular cemented tibial baseplate, and the revision stem and revision fluted stem are indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact. " The Natural-Knee II Durasul polyethylene components are indicated for patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. These devices are intended for cemented use only in the United States." Item numbers: 6212-00-007 6212-00-008 6212-00-009 6212-00-010 6212-00-011 6212-00-020 6212-00-021 6212-00-030 6212-00-031 6212-00-040 6212-00-041 6212-00-050 6212-00-051 6307-00-006 6307-00-007 6307-00-008 6307-00-009 6307-00-010 6307-00-011 6307-00-020 6307-00-021 6307-00-030 6307-00-031 6307-00-040 6307-00-041 6307-00-050 6307-00-051 Lot numbers: 11002695 11003148 11003157 11003159 11003165 11003167 11003170 11003181 11003190 11003192 11003193 11003195 11003196 11003201 11003212 11003214 11003216 11003223 11003228  ...
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Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices CR Flex GSF Porous Femoral LPS Flex GSF Porous Femoral LPS Flex Porous Femoral prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer various sizes This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " The CR-Flex GSF and LPS-Flex GSF uncoated (Option) and precoat styles are intended for cemented use only. " The CR-Flex GSF and LPS-Flex GSF porous coated femoral components may be used cemented or uncemented (biological fixation). " Specific uses with CR-Flex GSF or LPS-Flex GSF femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm Prolong® Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee Flex Congruent articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. The LPS-Flex GSF femoral, when used with LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees." Item numbers: 00-5752-013-01 00-5752-013-02 00-5752-013-05 00-5752-013-06 00-5752-014-01 00-5752-014-02 00-5752-014-05 00-5752-014-06 00-5752-015-01 00-5752-015-02 00-5752-015-05 00-5752-015-06 00-5752-016-01 00-5752-016-02 00-5752-016-05 00-5752-016-06 00-5752-017-01 00-5752-017-02 00-5752-017-05 00-5752-017-06 00-5762-013-51 00-5762-013-52 00-5762-014-51 00-5762-014-52 00-5762-015-51 00-5762-015-52 00-5762-016-51 00-5762-016-52 00-5762-017-51 00-5762-017-52 00-5962-012-51 00-5962-012-52 00-5962-013-51 00-5962-013-52 00-5962-014-51 00-5962-014-52 00-5962-015-51 00-5962-015-52 00-5962-016-51 00-5962-016-52 00-5962-017-51 00-5962-017-52 00-5962-018-51 00-5962-018-52 Lot numbers: 11003002 11003328  ...
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Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices NexGen LPS Flex Option Femoral NexGen LPS Flex Precoat Femoral prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " CR-Flex and LPS-Flex porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). CR-Flex HA/TCP porous coated femoral and tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only. " Specific uses with CR-Flex or LPS-Flex femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14 mm or 90-prefix 17 or 20 mm Prolong® Highly Crosslinked Polyethylene CR articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees. The LPS-Flex femoral, when used with the LPS-Flex articular surfaces, is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 155 degrees. " Specific Uses with NexGen LPS or LCCK femorals: The LPS femoral is designed for use with both cruciate ligaments excised and when load bearing ROM is expected to be less than or equal to 130 degrees. The usage of the LCCK femoral is the same as the LPS with the exception that femoral bone loss can be accommodated by femoral stem extensions and augmentation. No varus/valgus constraint or other stability other than that provided by the NexGen LPS is provided when the LCCK femoral component is used with the LPS-Flex articular surfaces." Item numbers: 00-5960-011-51 00-5960-011-52 00-5960-012-51 00-5960-012-52 00-5960-013-51 00-5960-013-52 00-5960-014-51 00-5960-014-52 00-5960-015-51 00-5960-015-52 00-5960-016-51 00-5960-016-52 00-5960-017-51 00-5960-017-52 00-5960-018-51 00-5960-018-52 00-5964-011-51 00-5964-011-52 00-5964-012-51 00-5964-012-52 00-5964-013-51 00-5964-013-52 00-5964-014-51 00-5964-014-52 00-5964-015-51 00-5964-015-52 00-5964-016-51 00-5964-016-52 00-5964-017-51 00-5964-017-52 Lot numbers: 11003819 11003822 11003824 11003955 11003973 11003997 11004042 11004086 11004103 11004104 11004105 11004160 11004166 11004173 11004174 11004188  ...
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Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing various sizes This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " CR-Flex porous coated femoral components may be used cemented or uncemented (biological fixation). CR-Flex HA/TCP porous coated femoral components may only be used uncemented. All other femoral and tibial baseplate components are indicated for cemented use only. " CR-Flex Mobile articular surfaces are intended for use with a functional posterior cruciate ligament (PCL). UC-Flex Mobile articular surfaces are intended for use with an absent or deficient PCL. " Specific uses with CR-Flex femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex femoral, when used with CR-Flex Mobile or UC-Flex Mobile articular surfaces, is intended for use when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees." Item numbers: 00-5930-010-01 00-5930-010-02 00-5930-020-01 00-5930-020-02 00-5930-030-01 00-5930-030-02 00-5930-040-01 00-5930-040-02 00-5930-040-41 00-5930-040-42 00-5930-050-01 00-5930-050-02 00-5930-060-01 00-5930-060-02 00-5930-070-01 00-5930-070-02 00-5930-080-01 00-5930-080-02 Lot numbers: 11002165 11002170 11002753 11002755 11004006 11004022 11004039 11004084 11004256 11004347 11004558 11004696 11005020 11005211 11005470 11005509 11005570 11005571 11005811 11006243 11006977 11007624 61785664 61785665 61785666 61785667 61790305 61790857  ...
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Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures." Item numbers: 00-8114-040-00 00-8114-050-00 Lot numbers: 61790499 61878931 61891348 61907682 61993208 61993210 62030932 62038367 62106796 62106797 62148557 62161479 62206538 Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices CPT 12/14 COCR prosthesis, hip, semi-constrained, metal/polymer, porous uncemented various sizes "The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures." Item numbers: 00-8114-000-00 00-8114-000-10 00-8114-001-00 00-8114-001-10 00-8114-002-00 00-8114-002-10 00-8114-002-18 00-8114-002-30 00-8114-003-00 00-8114-003-10 00-8114-003-18 00-8114-003-30 00-8114-004-00 00-8114-004-10 00-8114-004-20 00-8114-004-23 00-8114-004-26 00-8114-004-30 00-8114-005-00 00-8114-005-10 00-8114-005-30 00-8114-012-18 00-8114-013-18 Lot numbers: 61744462 61744471 61767815 61770620 61774067 61774069 61774070 61774071 61778347 61778352 61779345 61783709 61783710 61783712 61783713 61783715 61783716 61783717 61787012 61787026 61787032 61787033 61787039  ...
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Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices Bipolar Shell prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented various sizes Use of the MultiPolar Bipolar Cup is indicated in: Fracture dislocation of the hip. Elderly, debilitated patients when a total hip replacement is contraindicated. Irreducible fractures in which adequate fixation cannot be obtained. Certain high subcapital fractures and comminuted femoral neck fractures in the aged. Nonunion of femoral neck fractures. Secondary avascular necrosis of the femoral head. Pathological fractures of the femoral neck. Osteoarthritis in which the femoral head is primarily affected." Item numbers: 00-5001-038-00 00-5001-039-00 00-5001-040-00 00-5001-041-00 00-5001-042-00 00-5001-043-00 00-5001-044-00 00-5001-045-00 00-5001-046-00 00-5001-047-00 00-5001-048-00 00-5001-049-00 00-5001-050-00 00-5001-051-00 00-5001-052-00 00-5001-053-00 00-5001-054-00 00-5001-055-00 00-5001-057-00 00-5001-058-00 00-5001-060-00 00-5001-062-00 00-5001-064-00 00-5001-066-00 00-5001-068-00 00-5001-070-00 00-5001-072-00 Lot numbers: 00370174 00370176 00370178 00370181 00370453 00370454 00370455 00370457 00370461 00370665 00370751 00370810 00370858 00370859 00370860 00370866 00370867 00370868 00370869  ...
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Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. " Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected." Item numbers: 00-7843-011-16 00-7843-012-16 00-7843-013-16 00-7843-014-16 00-7843-015-16 00-7843-016-16 Lot numbers: 61760685 61781980 61840199 61844725 61844726 61951281 61956725 61968111 61987956 62011958 62029062 62034145 62097248 62097288 62120672 Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices VERSYS 7.5 INCH BEADED FC prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. " Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected." Item numbers: 00-7843-012-18 00-7843-013-18 00-7843-015-18 00-7843-015-24 00-7843-016-18 00-7843-016-24 00-7843-018-18 00-7843-018-24 00-7843-019-18 00-7843-019-24 00-7843-021-18 00-7843-021-24 00-7843-022-18 00-7843-022-24 Lot numbers: 11006277 61775244 61781982 61786860 61815081 61879442 61937678 61956718 61956722 61981808 61993659 62029064 62043111 62143772 77000810 77000822 Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices VERSYS 6 INCH BEADED FC 1 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. " Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected." Item numbers: 00-7843-011-26 00-7843-011-56 00-7843-012-26 00-7843-012-56 00-7843-013-26 00-7843-013-56 00-7843-014-26 00-7843-014-56 00-7843-015-26 00-7843-015-46 00-7843-015-56 00-7843-016-26 00-7843-016-46 00-7843-016-56 00-7843-017-26 00-7843-017-46 00-7843-017-56 00-7843-018-26 00-7843-018-46 00-7843-018-56 00-7843-019-26 00-7843-019-46 00-7843-019-56 00-7843-020-26 00-7843-020-46 00-7843-020-56 00-7843-021-26 00-7843-021-46 00-7843-021-56 00-7843-022-26 00-7843-022-46 00-7843-022-56 lot numbers: 11003828 11004140 11004141 11004945 11005429 11005666 61633498 61699577 61704382 61710259 61710265 61721708 61735803 61735804 61735807 61735808 61735811 61741803 61741804 61741807 61746866 61752732 61757179 61757188 61759235 61759263 61759264 61759265 61760620 61768678 61768681 61769239 61775245 61775247 61781979 61781993 61781994 61786857 61786859 61786862 61807096 61815089 61829365 61829366 61834825 61840229 61840235 61840236 61840240 61840243 61844742 61844743 61848234 61848238 61848248 61852817 61852823 61876837 61879443 61879446 61879450 61884825 61884826 61884830 61902329 61902374 61902382 61910047 61910048 61910049 61910050 61910051 61910057 61910058 61915343 61915348 61920858 61920859 61920860 61932609 61932610 61932611 61937670 61937671 61937679 61937680 61946016 61946017 61946018 61946026 61956713 61956714 61956724 61963719 61963728 61974966 61993630 62003641 62003642 62003643 62003719 62006778 62011971 62025498 62025499 62025503 62025504 62025509 62029069 62034134 62043097 62043107 62045160 62053687 62053689 62053692 62054926 62054928 62067444 62067446 62071763 62071764 62077676 62077680 62077681 62085290 62085291 62085293 62085296 62089502 62089504 62089509 62097215 62097232 62097258 62097289 62097296 62102129 62107875 62107877 62107878 62116476 62116532 62132186 62132187 62133140 62135309 62135311 62135317 62135322 62143764 62143773 62147263 62147267 62153941 62153947 62158853 77000593 77000594 77000595 77000596 77000597 77000598 77000990 77001428 77001429 77001431 77001433 77001543 77001550 Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices VERSYS 6 INCH BEADED FC 1 VERSYS 6 INCH BEADED FC S VERSYS 8 INCH BEADED FC 1 VERSYS 8 INCH BEADED FC 2 prosthesis, hip, semi-constrained, metal/polymer, porous uncemented "" Total hip replacement for the following: severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, nonunion of previous fractures of the femur; congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis; disability due to previous fusion; previously failed endoprostheses, and/or total hip components in the affected extremity and acute femoral neck fractures. " Hemi-hip replacement for the following: fracture dislocation of the hip; elderly, debilitated patients when a total hip replacement is contraindicated; irreducible fractures in which adequate fixation cannot be obtained; certain high subcapital fractures and comminuted femoral neck fractures in the aged; nonunion of femoral neck fractures; secondary avascular necrosis of the femoral head; pathological fractures of the femoral neck; and osteoarthritis in which the femoral head is primarily affected." Item numbers: 00-7843-011-06 00-7843-011-08 00-7843-011-36 00-7843-012-06 00-7843-012-08 00-7843-012-36 00-7843-013-06 00-7843-013-08 00-7843-013-36 00-7843-014-06 00-7843-014-08 00-7843-014-36 00-7843-015-06 00-7843-015-08 00-7843-015-36 00-7843-016-06 00-7843-016-08 00-7843-016-36 00-7843-017-06 00-7843-017-08 00-7843-017-36 00-7843-018-06 00-7843-018-08 00-7843-018-36 00-7843-019-06 00-7843-019-36 00-7843-020-06 00-7843-020-08 00-7843-020-36 00-7843-021-06 00-7843-021-36 00-7843-022-06 00-7843-022-36 Lot numbers: 11003968 11003975 11004089 11004219 11004274 11004333 11004746 11005067 11005118 11008034 61669552 61669554 61669559  ...
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Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices Metasul Head 40, 12/14, SZ M/0 total hip prosthesis - metal femoral heads Noninflammatory degenerative joint disease (NIDJD) including avascular necrosis, osteoarthritis, post-traumatic arthritis and congenital hip dysplasia and inflammatory joint disease (IJD) e.g. rheumatoid arthritis if bone quality is adequate. Failed previous surgery where pain, deformity, or dysfunction persists. Revision of previously failed hip arthroplasty. Total hip replacements may be considered for younger patients if any unequivocal indication outweighs the risks associated with the age of the patient and modified demands regarding activity and hip joint loading are assured. This includes severely handicapped patients with multiple joint involvement, for whom an immediate need of hip mobility leads to an expectation of significant improvement in the quality of their lives. The system is intended for use either with or without bone cement in total hip arthroplasty." Item number: 00-8770-040-02 Lots: 2564467 2573371 2625382 2631721 2655075 2655076 2685143 Class II LDPE bag containing the implant adheres to the highly polished implant surface. it is unlikely that adhesion of the LDPE bag would cause an adverse effect to either the patient or function of the implant. This conclusion was based on the following: " The LDPE material is biocompatible, similar to ultra high molecular weight polyethylene (UHMWPE). " LDPE is softer than the two mating materials of UHMWPE and cobalt chrome molybdenum (CoCrMo) and therefore, is not expected to scratch either wear surface, which could increase wear rates and possibly lead to osteolysis. " If there were wear particulates generated from the adhered film/residue of a LDPE bag they would be expected to elicit similar biologic reactions as those from UHMWPE and are unlikely to increase the likelihood of peri-prosthetic osteolysis. Zimmer Biomet, Inc.
Devices BD FMC7 FITC: Model 430918. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen. Product Usage: Analyte Specific Reagent. FMC7 is intended for in vitro diagnostic use in the identification of cells expressing FMC7 antigen. Model number: 340918: Lot number: 5341918. Incorrect expiry date on label 03/31/2017. correct expiry should be 6/30/16. Class III Becton, Dickinson and Company (BD) has determined that the FMC7 FITC (ASR) has an incorrect expiration date listed on the vial label. Becton, Dickinson and Company, BD Biosciences
Devices Stryker, T2 K-Wire 1.8 x 310 mm, Sterile Product Usage: Intended for the temporary stabilization of bone segments or fragments. Catalog number 0152-0218S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life Class II During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Stryker Howmedica Osteonics Corp.
Devices Stryker, METAIZEAU Intramedullary Pin, 2.0 x 400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments. Catalog number 0190-2000S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life Class II During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Stryker Howmedica Osteonics Corp.
Devices Stryker, Gamma K-Wire 3.2x450 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments. Catalog number 12106450S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life Class II During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Stryker Howmedica Osteonics Corp.
Devices Stryker, Gamma K-Wire 3.2x450 mm, UNS-Thread Product Usage: Intended for the temporary stabilization of bone segments or fragments. Catalog number 1210-6451S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life Class II During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Stryker Howmedica Osteonics Corp.
Devices Stryker, Gamma Guide Pin, 4x400 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments. Catalog number 1213-9091S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life Class II During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Stryker Howmedica Osteonics Corp.
Devices Stryker, Gamma3 K-Wire with Washer, 13x3.2x500 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments. Catalog number 1320-0016S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life Class II During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Stryker Howmedica Osteonics Corp.
Devices Stryker, T2 K-Wire, 3x285 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments. Catalog number 1806-0050S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life Class II During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Stryker Howmedica Osteonics Corp.
Devices Stryker, T2 K-Wire with washer, 7.8 x 3 x 285mm Product Usage: Intended for the temporary stabilization of bone segments or fragments. Catalog number 1806-0051S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life Class II During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Stryker Howmedica Osteonics Corp.
Devices Stryker, T2 Guidewire, Ball-Tipped, 3x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments. Catalog number 1806-0080S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life Class II During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Stryker Howmedica Osteonics Corp.
Devices Stryker, T2 Guidewire, Ball-Tipped, 2.5x800 mm Product Usage: Intended for the temporary stabilization of bone segments or fragments. Catalog number 1806-0083S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life Class II During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Stryker Howmedica Osteonics Corp.
Devices Stryker, T2 Guidewire, Ball-Tipped, 2.5 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments. Catalog number 1806-0084S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life Class II During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Stryker Howmedica Osteonics Corp.
Devices Stryker, T2 Guidewire, Ball-Tipped, 3 x 1000mm Product Usage: Intended for the temporary stabilization of bone segments or fragments. Catalog number 1806-0085S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life Class II During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Stryker Howmedica Osteonics Corp.
Devices Stryker, T2 Guidewire, Smooth-Tipped, 3 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments. Catalog number 1806-0090S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life Class II During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Stryker Howmedica Osteonics Corp.
Devices Stryker, T2 Guidewire, Smooth-Tipped, 2.2 x 800mm Product Usage: Intended for the temporary stabilization of bone segments or fragments. Catalog number 1806-0093S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life Class II During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Stryker Howmedica Osteonics Corp.
Devices Stryker, T2 Guidewire, Ball Tipped, 3 x 1250mm Product Usage: Intended for the temporary stabilization of bone segments or fragments. Catalog number 1806-1250S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life Class II During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Stryker Howmedica Osteonics Corp.
Devices Stryker, T2 Fixation K-Wire 3 x 285mm WCH coated Product Usage: Intended for the temporary stabilization of bone segments or fragments. Catalog number 1806-1417S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life Class II During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Stryker Howmedica Osteonics Corp.
Devices Stryker, T2 K-Wire, 3.2x400mm, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments. Catalog number 1806-3030S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life Class II During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Stryker Howmedica Osteonics Corp.
Devices Stryker, T2 K-Wire, 3.2x400mm, CoCr, Recon Product Usage: Intended for the temporary stabilization of bone segments or fragments. Catalog number 1806-3031S; All lots distributed before 10 Nov 2015 with non-expired 5 year shelf life Class II During a review of the packaging, it was determined that the seal integrity of the pouch may be decreased. Stryker Howmedica Osteonics Corp.
Food Purple Cow Limited Edition Cookie Butter Ice Cream, 8 oz. cups, packed in paper cartons UPC Code 13733 61945 and marked Best By November 21, 2016 Class I House of Flavors, Inc. is voluntarily recalling a small batch of 8 oz. cups of Purple Cow Limited Edition Cookie Butter Ice Cream, sold at Meijer stores, that contain Purple Cow Butter Pecan Ice Cream with a Purple Cow Butter Pecan lid. House Of Flavors, Inc.
Food Jody's Gourmet Popcorn, Fabulous Fudge Chocolate Walnut, net weight 8 oz. , one unit per package, packed in clear clamshell, expiration date 12/22/15 Batch Numbers: 1528802-F and 1528801-F Class II Jody's Inc. received a few notifications from people who bought the fudge as part of a school fund raiser that the fudge had mold on it. The expiration date of the fudge is 12/22/15, and it should not be growing mold yet. The firm immediately recalled the fudge. Jody's Gourmet Popcorn
Devices Flexor Check-Flo Introducer, Catheter introducer, Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Intended for introduction of balloons, closed and non-tapered end catheters or diagnostic and interventional devices Catalog #: KCFW-6.0-35-70-RB-HFANL0-HC Lot: 6166304 Class II Incorrect packaging. Reports of packages labeled as 6.0Fr actually containing 5.0Fr devices. Cook Inc.
Food STREGA Araldi allo (Chocolate nougat) Barcode #8001975006112; Codice 011104925/E Class II Undeclared gluten Penta Intenational, Inc.
Devices Convenience Kits from Centurion that contain an In-Vision- Plus Needleless IV Connector, Model: code RYM5001 InVision-Plus® Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use. ECVC1010 CVC INSERTION BUNDLE - 3L, 16CM Batch Exp. 2015042150 12/2016 2015061050 01/2017 2015062650 02/2017 2015071050 03/2017 2015081150 03/2017 ECVC1025 16CM CENTRAL LINE BUNDLE Batch Exp. 2015052750 12/2016 2015062250 01/2017 2015070150 02/2017 2015070950 03/2017 2015080650 03/2017 ECVC1425 20CM CENTRAL LINE BUNDLE Batch Exp. 2015041450 12/2016 2015052250 12/2016 2015062250 01/2017 2015070150 02/2017 ECVC1780 TRIPLE LUMEN BUNDLE Batch Exp. 2015041450 01/2017 2015081350 05/2017 ECVC1785 QUAD LUMEN BUNDLE Batch Exp. 2015052150 01/2017 2015061850 03/2017 ECVC3015 CVC TRIPLE LUMEN BUNDLE Batch  ...
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Class II Convenience Kits from Centurion contain an In-Vision-Plus Needleless IV Connector, code RYM5001 that is being recalled by the manufacturer, RyMed Technologies, LLC. According to the RyMed Technologies recall notice, the recall was initiated due to the identification of a component molding abnormality that may lead to female luer threads to crack, leading to potential for the mating tubing set to become detached and for the administration to be interrupted. Other components within these kits are not affected by the recalled product. Centurion Medical Products Corporation
Devices AccuLIF PL Tubing Set and AccuLIF TL Tubing Set AccuLIF is an interbody device system that uses hydraulic pressure to expand the implant in-situ. The purpose of the AccuLIF PL Tubing Set (cat#900301) and AccuLIF TL Tubing Set (cat#905103) is to deliver pressurized saline from a syringe to the AccuLIF implant for in-situ expansion. The Tubing Set attaches to the AccuLIF Insertion handle at two district locations: the "junction block" and the "manifold." The PL and TL Tubing Sets are Class 2 instruments not intended to sustain or support life. Catalog number 900301, Lot #01131543, 01261508, 10151404, 10271408, 12161403, 12161404, 09021404, 01261509, 10271407, 01261507, 10071415, 05011403, 06241407, 08071402, 10091305, 03041403, 01271412, 07281401, and 11061303. Catalog number 905103, 01131542, 11241408, 12161405, 12161406, 0211501, 01211502, 11241406, 02031403, 06241408, 07161407, 09101402, 09281401, 10251303, 05301402, 11241407, and 12101305. Class II There were two potential interference conditions identified with the way the tubing set attaches to the inserter. Stryker Spine
Devices Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine Manufactured by : Stryker Spine SAS France Used to facilitate insertion of the Aero-AL cage into the disc space. Lot #144933, 14D252, and 14D253. Class II Reported jamming of the impaction handle when assembled to the Inserter guide at the threads. Stryker Spine
Devices Auto Endo5 Hem-o-lok Automatic Clip Applier, Medium Large Polymer Clips, Rx Only, Sterile, REF 543965 Product Usage: The Weck Auto Endo5 hem-o-lok ML automatic endoscopic ligating clip appliers are indicated for use as delivery devices for Hem-o-lok ML non-absorbable polymer ligating clips. These appliers are designed for use with 5/5.5mm cannulas. Hem-o-lok Ligating Clips are intended for use in procedures involving ligation of vessels or tissue structures. 73J1500065, 73J1500066, 73J1500280, 73J1500440, 73J1500565, 73J1500566, 73K1500193 Class II The clip in the applier may be missing a boss. A boss is the part of the clip that is used to hold the clip within the applier jaws prior to application. Teleflex Medical
Devices EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a single use EkoSonic Endovascular Device which is comprised of an Intelligent Drug Delivery Catheter (IDDC) and removable MicroSonic Device (MSD), and a reusable EKOS EkoSonic Control System. During use, fluids are delivered through the side-holes of the IDDC. The MSD is placed through the central lumen of the IDDC to deliver ultrasound energy along the length of fluid delivery, dispersing the fluid into the intravascular treatment site. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non-sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device. Lot Number 150910004. Expiration date is August 15, 2018. Serial numbers: 001, 002, 003, 004, 005, 006, 007, 008, 009, 010 Class II The EkoSonic kit, including the individually labeled MicroSonic Device (MSD) and Intelligent Drug Delivery Catheter (IDDC) are labeled with a 135 cm working length, and programmed with a 135 cm family code, however the MSD actual working length is 106 cm. EKOS Corporation
Drugs Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for Injection, Rx only, Isomeric Pharmacy Solutions, 2401 Foothill Dr., Salt Lake City, UT 84109 Lot Number: 12212015@8, Do Not Use Beyond: 03/22/2016, "Compounded on December 21, 2015" Class III Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use Beyond" date or BUD (Before Use Date) that may be longer than intended. Isomeric Pharmacy Solution, LLC
Devices Philips IntelliVue Measurement Module X1 Model: M3001A Software Revision:K.21.54 or L.00.96 Class II The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor Philips Electronics North America Corporation
Devices Philips IntelliVue Module Measurement X2 Model: M3002A Software Revision: K.21.54 or L.00.96 Class II The ST elevation alarm on the Patient Monitor or standalone X2 Measurement Module will not sound when indicated for all chest leads derived using Hexad 12-Lead ECG Monitoring in the Host Monitor Philips Electronics North America Corporation
Drugs risperiDONE ORALLY DISINTEGRATING TABLETS, 2 mg, 30 Ct Bottles, Rx Only. Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC: 68382-156-06. Lot #: MP4967, Expiry: 04/2016. Class III Failed Impurities/Degradation Specifications: Out of specification for a known degradant. Zydus Pharmaceuticals USA Inc
Devices Evita Infinity V500 Ventilator; Babylog Infinity VN500 Ventilator. Ventilation. Catalog #s 8416400 and 8417400 Class I Draeger became aware of events during which the battery capacity of the optional PS500 power supply unit for the Infinity (ACS) Workstation Critical Care (Evita Infinity V500) and Infinity (ACS) Workstation Neonatal Care (Babylog VN500) was rapidly and unexpectedly reduced, despite using the most recent power supply firmware version 1.50 released in November 2015 (reference recall Z-0436-2016). The batteries were prematurely discharged, even though an adequate battery charge status was displayed on the device. Draeger Medical, Inc.
Food Fresh Express, Club Size, Chopped Romaine Lettuce, 32 oz., in clear flexible plastic bags, containing condiments in a separate clear flexible plastic bag. Use By Feb 19, G034A06A Class I Undeclared Allergens: milk, eggs, wheat and fish. Fresh Express Incorporated
Devices Olympus Scientific Solutions Americas Corporation ( OSSA ) Delta XRF Analyzer . This is a Analytical X-ray system All models of the Delta XRF Analyzer Class II The Firm has discovered a Software bug. Olympus Scientific Solutions Americas
Devices HipLOC CHS Plate/Lag Screw Introducer Catalog Number: 35-000263; and Lot Number Identification: 1807188, 1807189, 1943563, and 2577847. Class II A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked. Biomet, Inc.
Devices software for Syngo Dynamics a Picture Archiving and Communication System (PACS) intended for acceptance, transfer, display, storage, archive and manipulation of digital medical images, including quantification and report generation. Syngo Dynamics is not intended to be used for reading of mammography images. For model #10091673 Class II Siemens is releasing a software update that addresses an issue of mixing data from multiple patients. In rare situations, echo trend graphs may mix data from multiple patients. Siemens Medical Solutions USA, Inc
Drugs Medicated Better Braids, La Laque (salicylic acid) Spray, 2%,12 Fl. OZ. (355 ml.) bottle, Distributed by Keystone Laboratories, Memphis, TN 38101-2026, UPC 0 70596 00422 5. Lot #: 9AD5 Class II Microbial Contamination of a Non-Sterile Products: The product had a positive Staphylococcus aureus test result. Keystone Laboratories Inc
Devices Mammomat Inspiration with Tomosynthesis functionality Model number: 10140000 Class II A potential system fatal error may occur during tomosynthesis reconstruction with large breasts that cover nearly the entire detector surface and with a breast thickness larger than 90 mm. The data to be processed for the tomosynthesis application can exceed the capacity of the graphical processing unit (GPU). If the fatal error message occurs, reconstruction of the data will be aborted. The system will need to be rebooted. Siemens Medical Solutions USA, Inc
Drugs Normosol-M and 5% Dextrose (multiple electrolytes and 5% dextrose) Injection Type 1, USP, 1000 mL Single-Dose Container bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7965-09, Barcode (01) 0 030409 796509 0. Lot #: 56-853-FW, Exp 01AUG2017 Class III Labeling: Incorrect or Missing Lot and/or Exp Date: Confirmed customer report of an incorrect expiration date printed on the primary container labeled "01AUG1017" rather than "01AUG2017". Hospira Inc.
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