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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 06GS92453 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. American National Red Cross, The
Biologics Red Blood Cells Leukocytes Reduced 007GF08682, 007GF08684, 007GF08679, 007GF08683, 007GF08685, 007GF08686, 007GF08691, 007GF08700, 007GF08702, 007GF08687, 007GF08688, 007GF08694, 007GF08695, 007GF08701, 007GF08699, 007GF08689, 007GF08697 Class II Blood products, collected from donors whose hemoglobin determination was performed using expired microcuvettes, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 007FE44669, 007FE44667, 007FE44666, 007FE44663, 007FE44662, 007FE44661, 007FE44660, 007FE44659, 007FE44657, 007FE44656 Class III Blood products, collected using scales for which the quality control results were not documented, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 06KK04287, 06KK0428806, KK04193, 06KK04267, 06KK04130 Class III Blood products, in which quality control and distribution of products did not meet specifications, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 06KK04290, 06KH10582, 06KK04291, 06KK04130 Class III Blood products, in which quality control and distribution of products did not meet specifications, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 06GK20836 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Recovered Plasma 06GK20836 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Source Plasma 0230124137, 0230124642, 0230125300, 0230125851, 0230126581, 0230128020, 0230128531, 0230129104, 0230129657, 0230130244, 0230130860, 0230131470, 0230132051, 0230132569, 0230133157, 0230133666, 0230134222, 0230134805, 0230135449, 0230135976 Class II Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed. Biomat USA, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced FZ68866; LT17247; FZ69538 Class II Blood products, which quality control and distribution of products did not meet specifications, were distributed. Tri-counties Blood Bank
Biologics Red Blood Cells Leukocytes Reduced 042S19211 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. American National Red Cross (The)
Biologics Platelets Leukocytes Reduced 042S19211 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. American National Red Cross (The)
Biologics Red Blood Cells 01KH81493;01KH81496;01KH81499;01KK05209;01KK05214;01KX84353;01KX84355;01KX84356;01KX84358;01Q76121;01Q76123;01Q76124;01Q76128;01Q76129;01Y56415;01Y56417;01Y56419;01Y56421;01KH81504;01KH81503;01KH81501;01KH81500;01KH81498;01KH81497;01KK05212;01KK05208;01KK05204;01KK05203;01KH81502;01Y56420;01Q76127;01KX84354;01KX84352;01KF85597;01KF85596;01Y56423;01Q76131;01Q76130;01Q76126;01KX84357;01KX84351;01KX84348;01KX84347;01Y56422;01Q76125;01Q76132;01KK05206;01KK05207;01KH81495 Class III Blood products, not prepared in accordance with specifications, were distributed. American National Red Cross (The)
Biologics Red Blood Cells GS73316, GS73318, GS73305 Class III Blood products, which may have reached an unacceptable temperature during shipment, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Liquid Plasma GS73318 Class III Blood products, which may have reached an unacceptable temperature during shipment, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Red Blood Cells Leukocytes Reduced GQ58593, GP16828, GW67707, GW67697, GP16214, GP16225, GP16217, GP16216, GZ02392, GZ02376, GZ02394, GZ02427, GZ02426, GQ57036, GQ57037, GQ57034, GQ57040, GZ02413, GQ57047, GQ57044, GP12805, GP16152, GP16144, GP15223, GZ02059, GZ02064, GP14150, GP14774, GP14149, GP06096, GP16294, GP16254, GP16252, GP16285, GP16251, GP16256, GP16289, GP06105, GP06101, GP06098 Class III Blood products, which may have reached an unacceptable temperature during shipment, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Red Blood Cells (Apheresis) KP77163; KP77163 Class II Blood products, possibly air contaminated, were distributed. San Diego Blood Bank
Biologics Red Blood Cells 103337722 Class III Red Cell product, lacking a proper visual inspection for clots, was distributed. Blood Systems, Inc.
Biologics Red Blood Cells, codes: RC6, RC6LV, RC5 GS95665 GS95670 GS95674 GS93565 GS93572 GS85540 GS85539 GS95665 GS95670 GS95674 GS93565 GS93572 GS85540 GS85539 GS93568 GS93566 GS93564 GS93567 GS95675 GS95673 GS93570 GS95678 GS93574 GS93573 GS95677 GS93838 GS93837 GS93568 GS93566 GS93834 GS93564 GS93567 GS95675 GS95673 GS93570 GS93569 GS95678 GS93574 GS93573 GS95677 GS93838 GS93837 GS93835 GS93569 GS93835 GS93571 GS93571 GS67306 GS50734 GS62284 GS62287 GS67344 GS67895 GS32722 GS32726 GS50725 GS50726 GS50727 GS50728 GS50729 GS62283 GS62285 GS62295 GS62355 GS67298 GS67300 GS67304 GS67336 GS67560 GS67562 GS67858 GS69377 GS69391 GS69394 GS74669 GS62286 Class III Blood products, which exceeded time limits taken out of storage for labeling, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Red Blood Cells Leukocytes Reduced, codes: LRC6, LRC5, LRC3 GX94804 GW62803 GW62801 GX94808 GW62805 GX94803 GQ54219 GQ54221 GX94794 GX94799 GX94795 GX94790 GX94757 GX94758 GX94751 GX94760 GX94755 GX94763 GX94752 GX94767 GX94764 GX94768 GX94749 GX94761 GX94769 GX94754 GQ54034 GQ54017 GQ54016 Y96446 Y96451 GQ54217 Y96439 Y96442 Y96409 Y96422 Y96420 GY09002 GW79371 GW79385 GW79386 GW79382  ...
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Class III Blood products, which exceeded time limits taken out of storage for labeling, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Platelets Pheresis Leukocytes Reduced, Codes: LPAA, LPAB, LPA, LPAC GS50898 GS50917 GS50919 GS66370 GS66372 GS66373 GS68610 GS68614 GS68616 GS68617 GS68620 GS68621 GS68622 GS68627 GS68922 GS69379 GS69381 GS69463 GS69464 GS70344 GS70345 GS70346 GS70406 GS70407 GS70408 GS70410 GS70411 GS70412 GS70417 GS72560 GS72561 GS72566 GS72567 GS72913 GS72914 GS72915 GS72916 GS72918 GS72922 GS72923 GS73455 GS75510 GS75510 GS75512 GS75512 GS75530 GS75537 GS77276 GS77282 GS77287 GS77290 GS77291 GS77294 GS77296 GS78395 GS78541 GS78543 GS80419 GS84016 GS66356 GS66358 GS66362 GS68611 GS68612 GS68613 GS68615 GS68618 GS68619 GS68623 GS68625 GS68626 GS68917 GS68918 GS68919 GS68920 GS70347 GS70394 GS70402 GS70403 GS70404 GS70405 GS70409 GS70413 GS70414 GS70415 GS70416 GS72559 GS72562 GS72563 GS72565 GS72917 GS72920 GS72921 GS72924 GS72933 GS72936 GS72938 GS73396 GS73452 GS73456 GS74918 GS74921 GS74922 GS75523 GS75526 GS75531 GS75532 GS75533 GS75534 GS77283 GS77295 GS77297 GS78394 GS78396 GS78404 GS78406 GS80417 GS66356 GS66358 GS66362 GS68612 GS68613 GS68615 GS68618 GS68619 GS68623 GS68625 GS68626 GS68917 GS68918 GS68919 GS68920 GS70347 GS70394 GS70402 GS70403 GS70404 GS70405 GS70409 GS70413 GS70414 GS70415 GS70416 GS72559 GS72562 GS72563 GS72565 GS72917 GS72920 GS72921 GS72924 GS72933 GS72936 GS72938 GS73396 GS73397 GS73452 GS73456 GS74918 GS74921 GS74922 GS75523 GS75526 GS75526 GS75531 GS75533 GS75534 GS77283 GS77295 GS77297 GS78394 GS78396 GS78404 GS78406 GS78555 GS80417 GS66356 GS68613 GS70414 Class III Blood products, which exceeded time limits taken out of storage for labeling, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Platelets Pheresis Leukocytes Reduced Irradiated, Code: ILPAA GS73397 GS75526 Class III Blood products, which exceeded time limits taken out of storage for labeling, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Cryoprecipitated AHF, Pooled, Code: PCRY G09140 G09139 G09138 G07119 G07120 G07121 G07122 G07123 G07124 G07125 G07126 G07127 G07130 G07131 G07132 G07145 G07146 G07147 G07148 G07149 G07151 G07152 G07153 G07154 G07155 G07157 G07158 G07169 G07170 G07171 G07172 G07173 G07174 G07175 G07176 G07177 G07178 G07181 G07182 G07183 G07184 G08324 G08325 G08326 G08327 G08329 G08330 G08382 G08409 G08410 G08411 G08426 G08427 G08971 G08972 G08977 G08979 G09087 G09088 G09089 G09090 G09091 Class III Blood products, which exceeded time limits taken out of storage for labeling, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Cryoprecipitated Reduced, Code: CRY GN93464 GN96667 GN96700 GN96737 GN97580 GN97837 GN99456 GN99461 GN99464 GP00343 GP00355 GP00367 GP02213 GP02215 GP03171 GP03870 GP06177 GP06178 GP07347 GP07348 GP07925 GP07955 GP07982 GP09298 GP10343 GP10344 GP10660 GP11285 GP11497 GP12429 GP16144 GP16161 GP16176 GP16180 GP16188 GP16189 GP16194 GP16402 GP16633 GP16636 GP16659 GP16664 GP16671 GP16673 GP16679 GP16687 GP16689 GP16701 GP16712 GP16714 GP16726 GP16786 GP16799 GP16806 GP17382 GP17405 GP18518 GP18519 GP18522 GP18547 GP18549 GP20914 GP20922 GP20937 GP22386 GP22396 GP22686 GP22706 GS85943 GS85947 GS85969 GS87971 GS87972 GS87973 GS87977 GS87979 GS95309 GS95324 GX99180 GZ00077 GZ00111 GZ00710 GZ00975 GZ00982 GZ01977 GZ01985 GZ01988 GZ01990 GZ01996 GZ01997 GZ02009 GZ02013 GZ02026 GZ02028 GZ02040 GZ02268 GZ02273 GZ02302 GZ02315 GZ02317 GZ02321 GZ02323 GZ02330 GZ02331 GZ02341 GZ02351 GZ02574 GZ02578 GZ02586 GZ02591 GZ02602 GZ02612 GZ02928 GZ02929 GZ02937 GZ02942 GZ03004 GZ03005 GZ03011 GZ03012 GZ03018 GZ03030 GZ03053 GZ03055 GZ03057 GZ03069 GZ03075 GZ03299 GZ03301 GZ03303 GZ03304 GS62285 GS67560 Class III Blood products, which exceeded time limits taken out of storage for labeling, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Red Blood Cells Leukocytes Reduced 011KJ13127 (2 units), 011KJ13201 (2 units) Class II Blood products, for which the quality control testing was not performed, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 07FQ48267 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced W051408112578 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Community Blood Bank, Inc.
Biologics Source Plasma 09EINA0084, 09EINA0119, 09EINA0123, 09EINA0134, 09EINA0141, 09EINA0167, 09EINA0189, 09EINA0196, 09EINA0216, 09EINA0222, 09EINA0264, 09EINA0259, 09EINA0261, 09EINA0301, 09EINA0272, 09EINA0328, 09EINA0330, 09EINA0379, 09EINA0380, 09EINA0422, 09EINA0414, 09EINA0452, 09EINA0502, 09EINA0500, 09EINA0491, 09EINA0538, 09EINA0536, 09EINA0576, 09EINA0580, 09EINA0575, 09EINA0585, 09EINA0598, 09EINA0615, 09EINA0629, 09EINA0638, 09EINA0654, 09EINA0686, 09EINA0683, 09EINA0704, 09EINA0696, 09EINA0700, 09EINA0741, 09EINA0743, 09EINA0766, 09EINA0781, 09EINA0791, 09EINA0780, 09EINA0805, 09EINA0823, 09EINA0847,  ...
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Class II Blood products, collected from donors who did not have a complete physical examination, were distributed. BioLife Plasma Services L.P.
Biologics Source Plasma 09FMOE9547, 09FMOE9637, 09FMOE9704, 09FMOE9733, 09FMOE9974, 09FMOF0004, 09FMOF0088, 09FMOF0307, 09FMOF0324, 09FMOF0345, 09FMOF0361, 09FMOF0411, 09FMOF0418, 09FMOF0439, 09FMOF0475, 09FMOF0501, 09FMOF0549, 09FMOF0762, 09FMOF0893, 09FMOF0905, 09FMOF0926, 09FMOF0959, 09FMOF0984, 09FMOF1130, 09FMOF1158, 09FMOF1161, 09FMOF1168, 09FMOF1169, 09FMOF1269, 09FMOF1277, 09FMOF1317, 09FMOF1471, 09FMOF1479, 09FMOF1611, 09FMOF1633, 09FMOF1643, 09FMOF1651, 09FMOF1750, 09FMOF1847, 09FMOF1848, 09FMOF1970, 09FMOF2107, 09FMOF2121, 09FMOF2133, 09FMOF2183, 09FMOF2184, 09FMOF2213, 09FMOF2267, 09FMOF2336, 09FMOF2364,  ...
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Class II Blood products, collected from donors who may not have had a complete physical examination, were distributed. BioLife Plasma Services L.P.
Biologics Human Cornea for Transplant Preserved in Optisol GS --- Single Patient Use --- Lions Eye Bank at Albany 518-489-7606 NY1301009 R1 (Right) and NY1301009 L1 (Left); Class II Human Corneas, not tested to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. Sight Society of Northeastern New York Lions Eye Bank@Albany
Devices Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants. Software Versions: 3.7.1, 3.7.1.1, 3.7.2, 3.7.3.1, 3.7.3.3, 3.7.3.4, 3.7.3.5, 3.7.6.3, 3.7.3.7, and 3.7.3.8 Class II Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. These issues include: 1) With Auto-Fetch in use another patient's image may appear without user's intention. 2.a) In the case where dose administration time and image acquisition time fall on either side of midnight, the value will be under reported and close to zero for all pixel. 2.b) Decay correction tag (0054,1102) has a value "ADMIN" and the value reported will be exceedingly high. 2.c) In the "BQML" case where StartDateTime tag (0018,1078) is provided in place of StartTime (0018,1078) no value is reported and instead shows as "not calibrated". 3) For multi-frame images that contain more than one overlay, studies with frames where overlays overlap, the wrong overlay is displayed. For studies with frames that should display one overlay for specified amount of frames and a second overlay for specified amount of frames, no overlays are displayed at all. Ge Healthcare It
Devices Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images. Serial Numbers: 111, 114, 119-123, 125-126, 134, 142-143, 151-155, 161-169, 173-178,180-183, 188-192, 196-209, 211, 221-232, 235-249, 254, 261-270, 275-276, 279-286, 305, 312, 316-326, 330-337, 339-349, 353, 355, 357-365, 372-373, 375-376, 379-385, 387-388, 394-401, 403-405, 409-410, 412-415, 417, 420-421, 423, 431-435, 441-446, 451-461, 464-470, and 482-490 Class II Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch. Carestream Health, Inc.
Devices The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure. GE Centricity PACS Versions: 3.1.1.2, 3.2, 3.2.0.1, 3.2.0.2, 3.2.1, 3.2.2, 3.2.2.1, 3.2.2.2, 3.2.2.3, 3.2.6, 4.0, 4.0.1 Class II GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. These issues are as follows: 1) In Centricity RIS-IC, and a RIS-Driven integration, the "close" button closes the exam in RIS-IC, but does not close the exam in Centricity PACS RA1000 Workstation. 2) Interrupted workflow could break the synchronization between Nuance PowerScribe 360 and Centricity PACS RA1000 Workstation. 3) Interrupted workflow could break the synchronization between Agfa Talk and Centricity PACS RA1000 Workstation. GE Healthcare It
Biologics Red Blood Cells Leukocytes Reduced W036810061996; Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics Platelets Pheresis Leukocytes Reduced W036809202625; Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics Fresh Frozen Plasma W036810196346; W036810061996; W036809202625; 2547164; Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics Red Blood Cells W036810196346; 2547164; 2369454; Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics Cryoprecipitated AHF 2369454; Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics Platelets Pooled Leukocytes Reduced W036810815344; W036810802056; 2927802; 2911416; Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Devices pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO). Product Code: 023-1861-8; Serial Numbers: B1677 - B1826, F1827 - F2161, F2178 - F2198, F2216 - F2396, F2411 - F2452, F2464 - F2472, F2495 - F2523, F2533, F2550 - F2560, F2592 - F2601, F2614 - F2635, F2640 - F2648, F2662 - F2679, F2710 - F2853, F2855 - F2871, F2878 -  ...
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Class II The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number. Sysmex America Inc
Biologics Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined M12118; Class II Lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vaccine, with higher than specified levels of residual moisture, wwas distributed. NOVARTIS VACCINES AND DIAGNOSTICS S.r.l
Biologics Blood and Blood Products for Reprocessing 03LR08799 Class III Blood product, collected from an ineligible donor, was distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Leukocytes Reduced 004FJ98810; 004LV09482; 004LV10277 Class III Blood products, collected from an ineligible donor, were distributed. Arc Blood Services, New England Region
Devices Multipolar® Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip. Part Number Range: 00-5001-038/072-00 Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices CPT® Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SIZE 1 COCR; CPT 12/14 SIZE 1 COCR EXT CPT 12/14 STEM SIZE 2 COCR; CPT 12/14 SIZE 2 COCR EXT; CPT 12/14 SIZE 2 COCR 180MM; CPT 12/14 SIZE2 COCR XEXT; CPT 12/14 STEM SIZE 3 COCR; CPT 12/14 SIZE 3 COCR EXT; CPT 12/14 SZ 3 COCR 180MM EXT; CPT 12/14 SIZE 3 COCR XEXT; CPT 12/14 STEM SIZE 4 COCR; CPT 12/14 SIZE 4 COCR EXT; CPT 12/14 SIZE 4 COCR EXT; CPT 12/14 SZ 4 COCR 230MM EXT; CPT 12/14 SZ 4 COCR 260MM EXT; CPT 12/14 SIZE 4 COCR XEXT; CPT 12/14 STEM SIZE 5 COCR; CPT 12/14 SIZE 5 COCR EXT; CPT 12/14 SIZE 5 COCR XEXT; CPT 12/14 STEM 2-180 VALGUSNCK; CPT 12/14 STEM 3-180 VALGUSNCK; CPT 12/14 STEM X-SML COCR; and CPT 12/14 STEM SML COCR). Indicated for cemented use in patients suffering from severe hip pain. Part Number Range: 00-8114-000/050-00/30 Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices Versys® Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC 11X200MM 8ST; POR FULLCT FEM ST 11 LOW EXT; POR FULLCT FEM ST 11 EXT; POR FLCT FEM STEM LM 11X160MM; POR FULLCT LM FEM ST 11 EXT POR FULL-CT FEM ST 12X160MM VERSYS BEADED FC 12X200MM 8 ST POR FULLCT FEM ST 12 LOW EXT POR FLCT FEM ST 12.0X190 STR POR FULLCT FEM ST 12 EXT POR FULL-CT FEM ST LM 12X160MM POR FULLCT LM FEM ST 12 EXT POR FULL-CT FEM ST 13X160MM VERSYS HIP SYSTEM REVISION FEMORAL BEADED FULLCOAT PLUS COLL POR FULLCT FEM ST 13 LOW EXT POR FLCT FEM ST 13.5X190 STR POR FULLCT FEM ST 13 EXT POR FULL-CT FEM ST LM 13X160MM POR FULLCT LM FEM ST 13 EXT POR FULL-CT FEM ST 14X160MM VERSYS BEADED FC 14X200MM 8 ST POR FULLCT FEM ST 14 LOW EXT POR FULLCT FEM ST 14 EXT POR FULL-CT FEM ST LM 14X160MM POR FULLCT LM FEM ST 14 EXT POR FULL-CT FEM ST 15X160MM VERSYS BEADED FC 15X200MM 8 ST POR FULLCT FEM ST 15 LOW EXT POR FLCT FEM ST 15.0X190 STR POR FLCT FEM ST 15.0X250 STR POR FULLCT FEM ST 15 EXT POR FULL-CT FEM ST LM 15X160MM POR FULLCT FEM ST 15 XEXT POR FULLCT LM FEM ST 15 EXT POR FULL-CT FEM ST 16X160MM VERSYS BEADED FC 16X200MM 8 ST POR FULLCT FEM ST 16 LOW EXT POR FLCT FEM ST 16.5X190 STR POR FLCT FEM ST 16.5X250 STR POR FULLCT FEM ST 16 EXT POR FULL-CT FEM ST LM 16X160MM POR FULLCT FEM ST 16 XEXT POR FULLCT LM FEM ST 16 EXT POR FULL-CT FEM ST 17X160MM VERSYS BEADED FC 17X200MM 8 ST POR FULLCT FEM ST 17 EXT POR FULL-CT FEM ST LM 17X160MM POR FULLCT FEM ST 17 XEXT POR FULLCT LM FEM ST 17 EXT POR FULL-CT FEM ST 18X160MM VERSYS BEADED FC 18X200MM 8 ST POR FLCT FEM ST 18.0X190 STR POR FLCT FEM ST 18.0X250 STR POR FULLCT FEM ST 18 EXT POR FULL-CT FEM ST LM 18X160MM POR FULLCT FEM ST 18 XEXT POR FULLCT LM FEM ST 18 EXT POR FULL-CT FEM ST 19X160MM POR FLCT FEM ST 19.5X190 STR POR FLCT FEM ST 19.5X250 STR POR FULLCT FEM ST 19 EXT POR FLCT FEM STEM LM 19X160MM POR FULLCT FEM ST 19 XEXT POR FULLCT LM FEM ST 19 EXT POR FULL-CT FEM ST 20X160MM VERSYS BEADED FC 20X200MM 8 ST POR FULLCT FEM ST 20 EXT POR FLCT FEM STEM LM 20X160MM POR FULLCT FEM ST 20 XEXT POR FULLCT LM FEM ST 20 EXT POR FULL-CT FEM ST 21X160MM POR FLCT FEM ST 21.0X190 STR POR FLCT FEM ST 21.0X250 STR POR FULLCT FEM ST 21 EXT POR FLCT FEM STEM LM 21X160MM POR FULLCT FEM ST 21 XEXT POR FULLCT LM FEM ST 21 EXT POR FULLCT FEM STEM 22X160MM POR FLCT FEM ST 22.5X190 STR POR FLCT FEM ST 22.5X250 STR POR FULLCT FEM ST 22 EXT POR FLCT FEM STEM LM 22X160MM POR FULLCT FEM ST 22 XEXT POR FULLCT LM FEM ST 22 EXT. Used in total hip replacement. Part Number Range: 00-7843-011/022-06/56 Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices Metasul® Head. Intended for use either with or without bone cement in total hip arthroplasty. Part Number Range:00-8770-040-01/05 & 01.01062.405/408 Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices CoCr Head (Not distributed in the United States) Used in total hip replacement. Part Number Range:01.01012.405/408 Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices NexGen® Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R ; CR-FLEX GSF PCT SZ C-L MINUS; CR-FLEX GSF PCT SZ C-R MINUS ;CR-FLEX GSF PRECOAT SZ D-L; CR-FLEX GSF PRECOAT SZ D-R ;CR-FLEX GSF PCT SZ D-L MINUS ; CR-FLEX GSF PCT SZ D-R MINUS ;CR-FLEX GSF PRECOAT SZ E-L CR-FLEX GSF PRECOAT SZ E-R ;CR-FLEX GSF PCT SZ E-L MINUS ;CR-FLEX GSF PCT SZ E-R MINUS ;CR-FLEX GSF PRECOAT SZ F-L ;CR-FLEX GSF PRECOAT SZ F-R ;CR-FLEX GSF PCT SZ F-L MINUS ;CR-FLEX GSF PCT SZ F-R MINUS ;CR-FLEX GSF PRECOAT SZ G-L ;CR-FLEX GSK PRECOAT SZ G-R ;CR-FLEX GSF PCT SZ G-L MINUS ;CR-FLEX GSF PCT SZ G-R MINUS ; LPS-FLEX GSF OPT SZ C-L ; LPS-FLEX GSF OPT SZ C-R ;LPS-FLEX GSF OPT SZ D-L ;LPS-FLEX GSF OPT SZ D-R ;LPS-FLEX GSF OPT SZ E-L ;LPS-FLEX GSF OPT SZ E-R ;LPS-FLEX GSK OPT SZ F-L ;LPS-FLEX GSF OPT SZ F-R ;LPS-FLEX GSF OPT SZ G-L ; LPS-FLEX GSF OPT SZ G-R ;CR-FLEX PCT FEM B-L; CR-FLEX PCT FEM B-R; CR-FLEX PCT FEM C-L; CR-FLEX PCT FEM C-R; CR-FLEX PCT FEM C-L MINUS; CR-FLEX PCT FEM C-R MINUS; CR-FLEX PCT FEM D-L; CR-FLEX PCT FEM D-R; CR-FLEX PCT FEM D-L MINUS; CR-FLEX PCT FEM D-R MINUS; CR-FLEX PCT FEM E-L; CR-FLEX PCT FEM E-R; CR-FLEX PCT FEM E-L MINUS; CR-FLEX PCT FEM E-R MINUS; CR-FLEX PCT FEM F-L; CR-FLEX PCT FEM F-R; CR-FLEX PCT FEM F-L MINUS; CR-FLEX PCT FEM F-R MINUS; CR-FLEX PCT FEM G-L; CR-FLEX PCT FEM G-R; CR-FLEX PCT FEM G-L MINUS; CR-FLEX PCT FEM G-R MINUS; CR-FLEX POR FEM B-L; CR-FLEX POR FEM B-R; CR-FLEX POR FEM C-L; CR-FLEX POR FEM C-R; CR-FLEX POR FEM C-L MINUS; CR-FLEX POR FEM C-R MINUS; CR-FLEX POR FEM D-L; CR-FLEX POR FEM D-R; CR-FLEX POR FEM D-L MINUS; CR-FLEX POR FEM D-R MINUS; CR-FLEX POR FEM E-L; CR-FLEX POR FEM E-R; CR-FLEX POR FEM E-L MINUS; CR-FLEX POR FEM E-R; MINUS; CR-FLEX POR FEM F-L; CR-FLEX POR FEM F-R ;CR-FLEX POR FEM F-L MINUS; CR-FLEX POR FEM F-R MINUS; CR-FLEX POR FEM G-L; CR-FLEX POR FEM G-R; CR-FLEX POR FEM G-L MINUS CR-FLEX POR FEM G-R MINUS; CR-FLEX OPT FEM B-L; CR-FLEX OPT FEM B-R; CR-FLEX OPT FEM C-L; CR-FLEX OPT FEM C-R; CR-FLEX OPT FEM C-L MINUS; CR-FLEX OPT FEM C-R MINUS; CR-FLEX OPT FEM D-L; CR-FLEX OPT FEM D-R; CR-FLEX OPT FEM D-L MINUS; CR-FLEX OPT FEM D-R MINUS; CR-FLEX OPT FEM E-L; CR-FLEX OPT FEM E-R; CR-FLEX OPT FEM E-L MINUS; CR-FLEX OPT FEM E-R MINUS; CR-FLEX OPT FEM F-L; CR-FLEX OPT FEM F-R; CR-FLEX OPT FEM F-L MINUS; CR-FLEX OPT FEM F-R MINUS; CR-FLEX OPT FEM G-L; CR-FLEX OPT FEM G-R; CR-FLEX OPT FEM G-L MINUS; CR-FLEX OPT FEM G-R MINUS; LPS-FLEX CO-NID FEM A-L ; LPS-FLEX CO-NID FEM A-R ; LPS-FLEX RECOAT FEMORAL A-L; LPS-FLEX PRECOAT FEMORAL A-R; LPS-FLEX CO-NID FEM B-L ; LPS-FLEX CO-NID FEM B-R ; LPS-FLEX PRECOAT FEMORAL B-L; LPS-FLEX PRECOAT FEMORL B-R; LPS-FLEX CO-NID FEM C-L ; LPS-FLEX CO-NID FEM C-R ; LPS-FLEX PRECOAT FEMORAL C-L; LPS-FLEX PRECOAT FEMORAL C-R; LPS-FLEX CO-NID FEM D-L ; LPS-FLEX CO-NID FEM D-R ; LPS-FLEX PRECOAT FEMORAL D-L; LPS-FLEX PRECOAT FEMORAL D-R; LPS-FLEX CO-NID FEM E-L ; LPS-FLEX CO-NID FEM E-R ; LPS-FLEX PRECOAT FEMORAL E-L; LPS-FLEX PRECOAT FEMORAL E-R; LPS-FLEX CO-NID FEM F-L ; LPS-FLEX CO-NID FEM F-R ; LPS-FLEX PRECOAT FEMORAL F-L; LPS-FLEX PRECOAT FEMORAL F-R; LPS-FLEX CO-NID FEM G-L ; LPS-FLEX CO-NID FEM G-R ; LPS-FLEX PRECOAT FEMORAL G-L; LPS-FLEX PRECOAT FEMORAL G-R; LPS-FLEX PRECOAT FEMORAL H-L; LPS-FLEX PRECOAT FEMORAL H-R ; LPS-FLEX POROUS FEMORAL B-L ; LPS-FLEX POROUS FEMORAL B-R ; LPS-FLEX POROUS FEMORAL C-L ; LPS-FLEX POROUS FEMORAL C-R LPS-FLEX POROUS FEMORAL D-L ; LPS-FLEX POROUS FEMORAL D-R ; LPS-FLEX POROUS FEMORAL E-L ; LPS-FLEX POROUS FEMORAL E-R ; LPS-FLEX POROUS FEMORAL F-L ; LPS-FLEX POROUS FEMORAL F-R ;LPS-FLEX POROUS FEMORAL G-L ; LPS-FLEX POROUS FEMORAL G-R ; LPS-FLEX POROUS FEMORAL H-L ; LPS-FLEX POROUS FEMORAL H-R ; LPS-FLEX OPTION FEMORAL A-L; LPS-FLEX OPTION FEMORAL A-R; LPS-FLEX OPTION FEMORAL B-L; LPS-FLEX OPTION FEMORAL B-R; LPS-FLEX OPTION FEMORAL B-L ; LPS-FLEX OPTION FEMORAL B-R ; LPS-FLEX OPTION FEMORAL C-L; LPS-FLEX OPTION FEMORAL C-R; LPS-FLEX OPTION FEMORAL C-L; LPS-FLEX OPTION FEMORAL C-R; LPS-FLEX OPTION FEMORAL D-L; LPS-FLEX OPTION FEMORAL D-R; LPS-FLEX OPTION FEMORAL D-L; LPS-FLEX OPTION FEMORAL D-R; LPS-FLEX OPTION FEMORAL E-L; LPS-FLEX OPTION FEMORAL E-R; LPS-FLEX OPTION FEMORAL E-L; LPS-FLEX OPTION FEMORAL E-R; LPS-FLEX OPTION FEMORAL F-L; LPS-FLEX OPTION FEMORAL F-R; LPS-FLEX OPTION FEMORAL F-L; LPS-FLEX OPTION FEMORAL F-R; LPS-FLEX OPTION FEMORAL G-L; LPS-FLEX OPTION FEMORAL G-R; LPS-FLEX OPTION FEMORAL G-L; LPS-FLEX OPTION FEMORAL G-R; CR OPTION FEM COMP SIZE C/L; CR OPTION FEM COMP SIZE C/R; CR OPTION FEM COMP SIZE D/L; CR OPTION FEM COMP SIZE D/R; CR OPTION FEM COMP SIZE E/L; CR OPTION FEM COMP SIZE E/R; CR OPTION FEM COMP SIZE F/L; CR OPTION FEM COMP SIZE F/R; CR OPTION FEM COMP SIZE G/L; CR OPTION FEM COMP SIZE G/R; CR PRECOAT FEM COMP SIZE AML; CR PRECOAT FEM COMP SIZE AMR; CR PRC SURF HDN FEM CO-NID AML; CR PRC SURF HDN FEM CO-NID AMR; CR PRECOAT FEM COMP SIZE BML; CR PRECOAT FEM COMP SIZE BMR; CR PRC SURF HDN FEM CO-NID BML; CR PRC SURF HDN FEM CO-NID BMR; CR PRECOAT FEM COMP SIZE C/L; CR PRECOAT FEM COMP SIZE C/R; CR PRC FEM COMP SIZE CML ; CR PRC FEM COMP SIZE CMR ; CR PRC SURF HDN FEM CO-NID C-L ; CR PRC SURF HDN FEM CO-NID C-R ; CR PRC SURF HDN FEM CO-NID CML; CR PRC SURF HDN FEM CO-NID CMR; CR PRECOAT FEM COMP SIZE D/L; CR PRECOAT FEM COMP SIZE D/R; CR PRC FEM COMP SIZE DML ; CR PRC FEM COMP SIZE DMR ; CR PRC SURF HDN FEM CO-NID D-L ; CR PRC SURF HDN FEM CO-NID D-R ; CR PRC SURF HDN FEM CO-NID DML; CR PRC SURF HDN FEM CO-NID DMR; CR PRECOAT FEM COMP SIZE E/L; CR PRECOAT FEM COMP SIZE E/R; CR PRC FEM COMP EML ;CR PRC FEM COMP SIZE EMR ; CR PRC SURF HDN FEM CO-NID E-L ; CR PRC SURF HDN FEM CO-NID E-R ; CR PRC SURF HDN FEM CO-NID EML; CR PRC SURF HDN FEM CO-NID EMR; CR PRECOAT FEM COMP SIZE F/LCR PRECOAT FEM COMP SIZE F/R; CR PRC SURF HDN FEM CO-NID F-L; CR PRC SURF HDN FEM CO-NID F-R; CR PRECOAT FEM COMP SIZE G/L; CR PRECOAT FEM COMP SIZE G/R; CR PRC SURF HDN FEM CO-NID G-L; CR PRC SURF HDN FEM CO-NID G-R; CR PRECOAT FEM COMP SIZE H/L; CR PRECOAT FEM COMP SIZE H/R; CR PRC SURF HDN FEM CO-NID H-L ; CR PRC SURF HDN FEM CO-NID H-R ; CR POROUS FEM COMP SIZE AML; CR POROUS FEM COMP SIZE AMR; CR POR SURF HDN FEM CO-NID AML; CR POR SURF HDN FEM CO-NID AMR; CR POROUS FEM COMP SIZE BML; CR POROUS FEM COMP SIZE BMR; CR POR SURF HDN FEM CO-NID BML; CR POR SURF HDN FEM CO-NID BMR; CR POROUS FEM COMP SIZE C/L; CR POROUS FEM COMP SIZE C/R; NEXGEN POROUS FEMORAL CR SIZE CM, LEFT ; NEXGEN POROUS FEMORAL CR SIZE CM, RIGHT ; CR POR SURF HDN FEM CO-NID CML; CR POR SURF HDN FEM CO-NID CMR; CR POROUS FEM COMP SIZE D/L; CR POROUS FEM COMP SIZE D/R; NEXGEN POROUS FEMORAL CR SIZE DM, LEFT; NEXGEN POROUS FEMORAL CR SIZE DM, RIGHT; CR POR SURF HDN FEM CO-NID DML; CR POR SURF HDN FEM CO-NID DMR; CR POROUS FEM COMP SIZE E/L; CR POROUS FEM COMP SIZE E/R; NEXGEN POROUS FEMORAL CR SIZE EM, LEFT; NEXGEN POROUS FEMORAL CR SIZE EM, RIGHT; CR POR SURF HDN FEM CO-NID EML; CR POR SURF HDN FEM CO-NID EMR; CR POROUS FEM COMP SIZE F/L; CR POROUS FEM COMP SIZE F/R; CR POR SURF HDN FEM CO-NID F/L; CR POR SURF HDN FEM CO-NID F/R; CR POROUS FEM COMP SIZE G/L; CR POROUS FEM COMP SIZE G/R; CR POR SURF HDN FEM CO-NID G/L; CR POR SURF HDN FEM CO-NID G/R; CR POROUS FEM COMP SIZE H/L;CR POROUS FEM COMP SIZE H/R; NEXGEN POROUS FEMORAL CR SIZE HM, LEFT; NEXGEN POROUS FEMORAL CR SIZE HM, RIGHT; NEXGEN PMMA FEMORAL LPS SIZE A, LEFT; NEXGEN PMMA FEMORAL LPS SIZE A, RIGHT; NEXGEN PMMA SURFACED HARDENED FEMORAL LPS SIZE A, LEFT; NEXGEN PMMA SURFACED HARDENED FEMORAL LPS SIZE A, LEFT ; LPS PRECOAT FEM SIZE B-LT;LPS PRECOAT FEM SIZE B-RT; LPS PRECOAT SRF HDN FEM SZ B-L; LPS PRECOAT SRF HDN FEM SZ B-R; LPS PRECOAT FEM SIZE C-LT; LPS PRECOAT FEM SIZE C-RT; LPS PRECOAT SRF HDN FEM SZ C-L; LPS PRECOAT SRF HDN FEM SZ C-R; LPS PRECOAT FEM SIZE D-LT; LPS PRECOAT FEM SIZE D-RT; LPS PRECOAT SRF HDN FEM SZ D-L; LPS PRECOAT SRF HDN FEM SZ D-R; LPS PRECOAT FEM SIZE E-LT; LPS PRECOAT FEM SIZE E-RT; LPS PRECOAT SRF HDN FEM SZ E-L; LPS PRECOAT SRF HDN FEM SZ E-R; LPS PRECOAT FEM SIZE F-LT; LPS PRECOAT FEM SIZE F-RT; LPS PRECOAT SRF HDN FEM SZ F-L; LPS PRECOAT SRF HDN FEM SZ F-R; LPS PRECOAT FEM SIZE G-LT; LPS PRECOAT FEM SIZE G-RT; LPS PRECOAT SRF HDN FEM SZ G-L; LPS PRECOAT SRF HDN FEM SZ G-R; LPS PRECOAT FEM IMPLANT SZ G-L; LPS PRECOAT FEM IMPLANT SZ G-R; NEXGEN PMMA FEMORAL LPS SIZE H, LEFT ;NEXGEN PMMA FEMORAL LPS SIZE H, RIGHT; NEXGEN PMMA SURFACED HARDENED FEMORAL LPS SIZE H, LEFT; NEXGEN PMMA SURFACED HARDENED FEMORAL LPS SIZE H, LEFT; LPS POROUS FEM SIZE B-LT; LPS POROUS FEM SIZE B-RT; LPS POROUS SRF HDN FEM SZ B-LT; LPS POROUS SRF HDN FEM SZ B-RT; LPS POROUS FEM SIZE C-LT; LPS POROUS FEM SIZE C-RT; LPS POROUS SRF HDN FEM SZ C-LT; LPS POROUS SRF HDN FEM SZ C-RT; LPS POROUS FEM SIZE D-LT; LPS POROUS FEM SIZE D-RT; LPS POROUS SRF HDN FEM SZ D-LT; LPS POROUS SRF HDN FEM SZ D-RT; LPS POROUS FEM SIZE E-LT; LPS POROUS FEM SIZE E-RT; LPS POROUS SRF HDN FEM SZ E-LT; LPS POROUS SRF HDN FEM SZ E-RT; LPS POROUS FEM SIZE F-LT; LPS POROUS FEM SIZE F-RT; LPS POROUS SRF HDN FEM SZ F-LT; LPS POROUS SRF HDN FEM SZ F-RT;LPS POROUS FEM SIZE G-LT: LPS POROUS FEM SIZE G-RT; LPS POROUS SRF HDN FEM SZ G-LT; LPS POROUS SRF HDN FEM SZ G-RT; LPS POROUS FEM IMPLANT SZ G-L; LPS POROUS FEM IMPLANT SZ G-R; LPS POROUS FEM SIZE H-LT; LPS POROUS FEM SIZE H-RT; LPS POROUS SRF HDN FEM SZ H-LT; LPS POROUS SRF HDN FEM SZ H-RT; LCCK FEM COMP SZ C-L; LCCK FEM COMP SZ C-R; LCCK FEM IMPLANT SZ C-L; LCCK FEM IMPLANT SZ C-R; LCCK FEM COMP SZ D-L; LCCK FEM COMP SZ D-R; LCCK FEM IMPLANT SZ D-L; LCCK FEM IMPLANT SZ D-R; LCCK FEM COMP SZ E-L; LCCK FEM COMP SZ E-R; LCCK FEM IMPLANT SZ E-L; LCCK FEM IMPLANT SZ E-R; LCCK FEM COMP SZ F-L; LCCK FEM COMP SZ F-R; LCCK FEM IMPLANT SZ F-L; LCCK FEM IMPLANT SZ F-R; LCCK FEM COMP SZ G-L; LCCK FEM COMP SZ G-R; LCCK FEM IMPLANT SZ G-L; LCCK FEM IMPLANT SZ G-R; LPS FEM COMP SZ A-L; LPS FEM COMP SZ A-R; LPS OPTION FEMORAL A-L; LPS OPTION FEMORAL A-R; LPS FEM COMP SZ B-L; LPS FEM COMP SZ B-R; LPS OPTION FEMORAL B-L; LPS OPTION FEMORAL B-R; LPS FEM COMP SZ C-L; LPS FEM COMP SZ C-R; LPS OPTION FEMORAL C-L; LPS OPTION FEMORAL C-R; LPS FEM COMP SZ D-L; LPS FEM COMP SZ D-R; LPS OPTION FEMORAL D-L; LPS OPTION FEMORAL D-R; LPS FEM COMP SZ E-LLPS FEM COMP SZ E-R; LPS OPTION FEMORAL E-L; LPS OPTION FEMORAL E-R; LPS FEM COMP SZ F-L; LPS FEM COMP SZ F-R; LPS OPTION FEMORAL F-L; LPS OPTION FEMORAL F-R; LPS FEM COMP SZ G-L; LPS FEM COMP SZ G-R; LPS OPTION FEMORAL G-L; LPS OPTION FEMORAL G-R; LPS FEM IMPLANT SZ G-L; LPS FEM IMPLANT SZ G-R; LPS FEM COMP SZ H-L; LPS FEM COMP SZ H-R; LPS OPTION FEMORAL H-L; LPS OPTION FEMORAL H-R; LPS FEM IMPLANT SZ H-L; LPS FEM IMPLANT SZ H-R). Provides increased flexion capability. Part Number Range: 005750, 5764, 5950, 5952, 5956, 5960, 5962, 5964, 5966, 5970, 5972, 5990, 5992, 5994, and 5996-011/018-01/92. Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices NexGen® Femoral Component (CR-FLEX GSF POR FEM, C-L; CR-FLEX GSF POR FEM, C-R; CR-FLEX GSF POR FEM, C-L MINUS; CR-FLEX GSF POR FEM, C-R MINUS; CR-FLEX GSF POR FEM, D-L; CR-FLEX GSF POR FEM, D-R CR-FLEX GSF POR FEM, D-L MINUS; CR-FLEX GSF POR FEM, D-R MINUS CR-FLEX GSF POR FEM, E-L; CR-FLEX GSF POR FEM, E-R; CR-FLEX GSF POR FEM, E-L MINUS; CR-FLEX GSF POR FEM, E-R MINUS; CR-FLEX GSF POR FEM, F-L ; CR-FLEX GSF POR FEM, F-R; CR-FLEX GSF POR FEM, F-L MINUS; CR-FLEX GSF POR FEM, F-R MINUS; CR-FLEX GSF POR FEM, G-L CR-FLEX GSF POR FEM, G-R; CR-FLEX GSF POR FEM, G-L MINUS CR-FLEX GSF POR FEM, G-R MINUS; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE C, LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE C, RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE D, LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE D, RIGHT; LPS-FLEX GSF POR FEM, E-L; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE E, RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE G, LEFT; and NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE G, RIGHT). Provides increased flexion capability. Part Number Range: 5752 and 5762. Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices Natural-Knee® Flex Femoral Component. Provides increased flexion capability. Part Number Range: 00-5410,5412,5414,and 5416-013/018-01/02. Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices Zimmer® Unicompartmental Knee Femoral Component. Indicated for patients with painful and/or disabling knee joint. Part Number Range:00-5842-011/017-01/02 Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices Gender Solutions" Patello-Femoral Component Part Number Range:00-5926-011/015-01/02 Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices Natural-Knee® II Femoral Component Part Number Range:6212, 6307-00-006/051 Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices Sidus" Head (Not distributed in the United States) Part Number Range: 01.04555.380/525 Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States) Part Number Range:005930-010/080-01/02 Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas. Serial numbers: U.S. - 134,152,173,174,200,205,222,312,349,353,412, Worldwide Serial numbers: 469, 445, 306, 410, 453, 204, 483, 300, 171, 218 Class II During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an artifact. This issue was discovered in manufacturing. It occurs when the DRX product console software is updated to v5.6b software and the detector is not calibrated before use. Carestream Health, Inc.
Biologics Cornea 2010161C; 2010162C Class III Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 201051C; 201052C Class III Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 2009169C; 2009170C Class III Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Lions Eye Bank For Long Island
Devices PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. 287105005 Class II Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. DePuy Spine, Inc.
Devices PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. 287105010 Class II Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. DePuy Spine, Inc.
Devices PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. 287105014 Class II Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. DePuy Spine, Inc.
Devices PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. 287105018 Class II Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. DePuy Spine, Inc.
Devices PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. 287105090 Class II Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. DePuy Spine, Inc.
Biologics HLA Fusion Software; version 2.0.0 SP4.1, Catalog ID FUSPGR HLA Fusion Software (version 2.0.0, SP4.1; Catalog ID FUSPGR (With Luminex xPONENT Software 3.1) Class II HLA Fusion Version 2.0.0-SP4.1, with a defect or glitch causing a conversion error giving incorrect test results for certain beads, was distributed. One Lambda Inc
Devices HemoCue® Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes Model Number 110608 Lot Number: 1210865, 1210873, 1211878, 1301893, 1302810, 1303836, 1304838, 1304840 and 1304842. Model Number 110610 Lot Number: 1209857, 1210870, 1211874, 1211879, 1212885, 1301803, 1301893, 1302817 and 1302818. Model Number 110611 Lot Number: 1208848, 1208853, 1208854, 1209855, 1209856, 1209858, 1209860, 1209862, 1210863, 1210865, 1210869, 1210871, 1210872, 1210873, 1211875, 1211876, 1211877,  ...
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Class II HemoCue AB has become aware of a production related problem involving punctured HemoCue® Urine Albumin Microcuvettes single pack pouches. HemoCue AB
Devices HemoCue® Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden Part Number 111715: Lot numbers1208655, 1208658, 1208659, 1208660, 1208663, 1208664, 1209667, 1209669, 1209670, 1209671, 1209672, 1209674, 1209675, 1209677, 1209678, 1210681, 1210683, 1210685, 1210688, 1211690, 1211691, 1211692, 1211694, 1211696, 1211697, 1211699, 1212701, 1212702, 1212703, 1212705, 1212706, 1301708, 1301710, 1301711, 1301712, 1301715, 1301717, 1301719, 1302721, 1302723, 1302725, 1302726, 1303729, 1303734 & 1304737. Part  ...
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Class II HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches. HemoCue AB
Devices Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion Part No.: 03.501.080 with multiple lot numbers: 3783492 3783913 3788496 3822332 7516728 7606881 7635218 7653178 7659168 7666085 7671934 7679825 7689244 7694377 7700691 7705157 7720599 7738572 7738573 7740498 7742713 7767497 7797648 7803768 7806881 7818677 7818682 7821672 7827088 7831855 7833606 7858407 8068078 Class II When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant. Synthes USA HQ, Inc.
Devices Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging Lot Numbers not utilized. Serial Numbers: LGA0792628 LGA0792564 LGA0792565 LGA0792531 LGA0792540 LGA0792541 LGA0792617 LGA0792554 LGA0792626 LGA0792627 LGA0792552 LGA0792616 LGA0792563 LGA0792553 LGA0792615 LGA0792551 LGA0792613 Class II The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly cause the patient to be burned during the procedure:1. The system is set to 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode, and 2) "IQBalance BD" or "IQ Balance" BCD" is displayed on the touch panel as a result of scale setting for PW mode. Toshiba American Medical Systems Inc
Devices Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging Lot Numbers not utilized. Serial Numbers: 99A07Y2151 99E0993437 99K1285044 99F1033857 99F1033858 99F1033859 99K11Z4906 99K11Z4907 99J1114445 99G1094194 99H10X4240 99E0973301 99G1074050 99G1074051 99G1074052 99E0973302 99J1114443 99G1084118 99D0892684 99K1184804 99D08Y2744 99K1285039 99K11Z4917 99E0963141 99E0963157 99E0963158 99E0963168 99D0892680 99D0892687 99D08Z2840 99D0953122 99E0973308 99E09X3463 99F09Z3684 99D08Z2829 99E0993408 99K1285041 99D0892692 99A07Y2109 99E0993414 99E0993415 99K1214940 99E0983369 99D0892688  ...
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Class II The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly cause the patient to be burned during the procedure:1. The system is set to 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode, and 2) "IQBalance BD" or "IQ Balance" BCD" is displayed on the touch panel as a result of scale setting for PW mode. Toshiba American Medical Systems Inc
Devices Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging Lot Numbers not utilized. Serial Numbers: A1G1194387 A1E10Z3293 A1E10Z3294 99A09Y2120 99B09Z2178 99B09Z2179 A1F1143915 A1G1194385 A1G1194394 A1G1194395 A1G1194396 A1E10Z3339 A1E10Z3340 A1E10Z3341 A1G11Z4565 99B09Z2174 A1G1174188 A1G1194355 A1G1194356 A1G1184257 A1G1184258 A1G1194392 A1G1194406 99B1022343 A1F1113439 A1F1133733 A1F1133846 A1C1072756 A1C1072763 A1C1082867 99A09X2090 99A09X2092 A1C1093010 A1G1214637 A1G11Z4566 A1E10Z3295 A1E10Z3308 A1E10Z3312 A1G1194397 A1E10Z3311 A1F1123626 A1F1123633 A1C1082816 A1C1082830  ...
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Class II The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly cause the patient to be burned during the procedure:1. The system is set to 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode, and 2) "IQBalance BD" or "IQ Balance" BCD" is displayed on the touch panel as a result of scale setting for PW mode. Toshiba American Medical Systems Inc
Devices Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging Lot Numbers not utilized. Serial Numbers: 99D0833447 99E0873714 99G0995029 99D0823343 99F0924404 99G09Y5216 99E0863552 99E0863553 99G0964771 99C0792920 99F0893870 99B06Z2073 99C07X2964 99C0792918 99B06Z2063 99C0792919 99G0964712 99G0964713 99G0974899 99F0944563 99D0823349 99G0995131 99G0995132 99G0995133 99G0995134 99G09Y5224 99C0792914 99D0813229 99D0813230 99D0813231 99E0873711 99E0873716 99E0873717 99B06Z2072 99B0752508 99B0752509 99B0752510 99B0752511 99C0792915 99C0792937 99F0893967 99F08Y4079 99F08Y4085 99F08Y4086  ...
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Class II The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly cause the patient to be burned during the procedure:1. The system is set to 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode, and 2) "IQBalance BD" or "IQ Balance" BCD" is displayed on the touch panel as a result of scale setting for PW mode. Toshiba American Medical Systems Inc
Biologics Honey Bee Venom A1200016; A1200053; A1300028; A1300051; M26969B; M26969F; M32153B; A1200030; A1200090; A1300033; D26969A; D26969E; D32153A; A1200054; A1200121; A1200006; A1300059; Class II Diluent containing phenol failed an apperance test on stability. The Diluent is included in the JHS licensed venomil kits that were distributed. Jubilant HollisterStier, LLC
Biologics White Faced Hornet Venom Protein A1200032; A1200100; A1300043; M26862H; A1200019; A1200080; A1200123; A1300031; D26862F; A1300025; D26862E; A1200079; M26862I Class II Diluent containing phenol failed an apperance test on stability. The Diluent is included in the JHS licensed venomil kits that were distributed. Jubilant HollisterStier, LLC
Biologics Yellow Hornet Venom Protein A1200035; A1200099; A1300032; M26865I; A1200018; A1200125; A1300034; D26865H; A1200007; D26865G; A1200005; A1200078; A1200089; M26865F Class II Diluent containing phenol failed an apperance test on stability. The Diluent is included in the JHS licensed venomil kits that were distributed. Jubilant HollisterStier, LLC
Biologics Wasp Venom Protein A1200115; A1200052; A1200057; A1300029; M29636C; M31619A; A1200033; A1200104; A1300035; D29636B; D31619B; A1200009; A1200008; A1200096; A1300068; M29636A Class II Diluent containing phenol failed an apperance test on stability. The Diluent is included in the JHS licensed venomil kits that were distributed. Jubilant HollisterStier, LLC
Biologics Yellow Jacket Venom Protein A1300024; D26968D; D29155C; A1200045; A1200076; M29155A; A1200017; A1200077; D26968E; D29155D; A1300026; M26968F; M29155B Class II Diluent containing phenol failed an apperance test on stability. The Diluent is included in the JHS licensed venomil kits that were distributed. Jubilant HollisterStier, LLC
Biologics Mixed Vespid Venom Protein A1200020; A1200068; A1300030; A1300054; M27840A; M30396B; A1200075; A1300027; M27840B; M30396A; M31296A Class II Diluent containing phenol failed an apperance test on stability. The Diluent is included in the JHS licensed venomil kits that were distributed. Jubilant HollisterStier, LLC
Food Amport Foods Chocolate Raisins. Net Wt. 12 oz (340g). UPC 71725-71190. Allergy Information: This product is produced on equipment shared with peanuts and tree nut products. Lot 078X344 Exp 12-19-13 Class II It was discovered that a package of Milk Chocolate Peanuts was erroneously labeled as Milk Chocolate Raisins. American Importing Co, Inc
Biologics Ortho Verseia Pipetter (VERSEIA) All VERSEIA Pipetters with software Versions 2.2, 2.3, 3.0 and 3.1; (Product Code: 5561701) There is no expiration date for these serialized products. Class III ORTHO VERSEIA Pipetter software, with a defect or glitch that in certain circumstances during plate processing, has the potential for false negative results. Ortho Clinical Diagnostics Inc
Devices Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment. Model Number EG-530UT2. Serial Numbers: NU038A018, NU038A019, NU038A022, NU038A027, NU038A028 and NU038A029 Class II A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps Inlet (biopsy inlet port) to the endoscope. Fujinon Inc
Devices Siemens RAPIDPoint® 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili All Serial Numbers Class II RAPIDPoint® 400 Series, RAPIDPoint® 500, or RAPIDLab® 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample Siemens Healthcare Diagnostics Inc
Devices Siemens RAPIDPoint® 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili All Serial Numbers Class II RAPIDPoint® 400 Series, RAPIDPoint® 500, or RAPIDLab® 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample Siemens Healthcare Diagnostics Inc
Devices Siemens RAPIDPoint® 500 system blood gas analyzer Product Usage: RAPIDPoint 500 System: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili All Serial Numbers Class II RAPIDPoint® 400 Series, RAPIDPoint® 500, or RAPIDLab® 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample Siemens Healthcare Diagnostics Inc
Devices Siemens RAPIDLab® 1240 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb All Serial Numbers Class II RAPIDPoint® 400 Series, RAPIDPoint® 500, or RAPIDLab® 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample Siemens Healthcare Diagnostics Inc
Devices Siemens RAPIDLab® 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb All Serial Numbers Class II RAPIDPoint® 400 Series, RAPIDPoint® 500, or RAPIDLab® 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample Siemens Healthcare Diagnostics Inc
Devices Siemens RAPIDLab® 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb All Serial Numbers Class II RAPIDPoint® 400 Series, RAPIDPoint® 500, or RAPIDLab® 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample Siemens Healthcare Diagnostics Inc
Devices Siemens RAPIDLab® 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb All Serial Numbers Class II RAPIDPoint® 400 Series, RAPIDPoint® 500, or RAPIDLab® 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample Siemens Healthcare Diagnostics Inc
Drugs Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL sizes, Fallon Wellness Pharmacy, Latham, NY 12110. Lot #: 08052013@84, Exp 11/5/2013 Class II Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility assurance concerns based on testing of this lot by a third party lab, indicating that test results reported as passing sterility may have been inaccurate. Fallon Wellness Pharmacy Llc
Devices Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other Oran imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders The detection, localization, and staging of tumors and diagnosing cancer patients. Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for quantification of cardiology images and data sets including but not limited to myocardial perfusion for the display of wall motion and quantification ventricular or left-function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated. Model # 882456; Serial Number: 2003 -2013 and 2015 - 2019. Class II Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the event that a patient rescan were to require reinjection of PET radiopharmaceutical. Philips Medical Systems (Cleveland) Inc
Devices Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system. R13D09024, R13D09107, R13D12101, R13D17068, R13D18066, R13D20070 Class II Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471 Baxter Healthcare Corp.
Devices Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation, Deerfield IL 60015. For use with a vascular access device for the administration of drugs and solutions. The Clearlink Luer Activated Valve is an in-line injection site, which can be connected to standard male Luer adapters for continuous or intermittent fluid administration or the withdrawal of fluids. UR13C11089, UR13D16060 Class II The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could lead to potential contamination. Baxter Healthcare Corp.
Devices Brand Names: Integra® Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively. Common Name: Intracranial Pressure and Pressure-Temperature Monitoring Kits Classification Name: Device, Monitoring, Intracranial Pressure 510(k) Number: K102875 The Camino 110-4 Intracranial Pressure monitoring catheters are sterile transducer-tipped pressure monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature.  The Camino 110-4B catheter is used for Intracranial Pressure Monitoring in the parenchyma or subarachnoid space.  The Camino 110-4G catheter is used for Post Craniotomy Subdural Pressure Monitoring.  The Camino 110-4H catheter is intended for Intracranial Pressure Monitoring and Cerebrospinal fluid drainage.  The Camino 110-4L catheter is intended for use with the Licox® Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma.  The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. Lot Numbers: Catalog Number 110-4B: 3050RX195484, 3050RX198473, 305000205426, 3050RX197641, 3050RX201421, 305000205648, 305000205652, 3050RX199149, 3050RX201407, 3050RX199850, 305000205976, 3050RY189979, 3050RX200862, 305000206178, 3050RY193648, 3050RX200486, 3050RX181026, 3050RX185115, 3050RY195484, 305000207061, 305000207062, 3050RY198473, 305000207330, 305000207334, 3050RY197641, 3050RY200862, 305000207580, 305000207892, 3050RY200486, 3050RY181026, 3050RY185115, 3050RX207330, 3050RX207334, 3050RX207580,  ...
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Class II Integra LifeSciences has identified through an internal evaluation that in order to comply with US FDA requirements, certain Camino® Intracranial Pressure Monitoring Kits require additional labelling to indicate they are UNSAFE in an MR environment. Only the following Camino® Intracranial Pressure Monitoring Kits are affected: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. Integra Limited
Food Schwebel's Golden Rich Bun with Honey, 18 oz plastic bag, 12 count, UPC 0 71319 00083 8 Product labeled in part, "INGREDIENTS: ENRICHED WHEAT FLOUR***CONTAINS: WHEAT, SOY SCHWEBEL BAKING CO. YOUNGSTOWN, OH 44501" Lot #CAFC8W, Best By Sept 21, Lot #CAFC7B, Best By Sept 20 Class I Undeclared eggs. Schwebel Baking Company
Devices Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse Bone Void Filleris a bone graft extender to be used with autogenous bone marrow aspirate or autograft Part number 838.202S (2.5cc), with lot # GBN299BB and expiration date October 2013, and lot #GBN355AB, with expiration date December 2013: and part # 838.210S (10cc) with lot # GBN319AB, with expiration date November 2013, and GBN320BB with expiration date November 2013. Class II The sterility of the product cannot be assured. Globus Medical, Inc.
Devices chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the detection of Salmonella in human specimens. Lot 1002234210 and 1002300040 Class II Complaints for Salmonella strains growing on this medium producing an uncharacteristic white colored colony instead of the expected pale pink to mauve colored colonies. This could potentially lead to Salmonella colonies not being detected. bioMerieux, Inc.
Devices Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D. The EMBOL-X access device is indicated for the perfusion of the ascending aorta during short-term (less than or equal to0¤ 6 hours) cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system. Model No: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D. Class I Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip. Edwards Lifesciences, LLC
Food P.F. Chang's Home Menu, Pork & Leek Dumplings, frozen, packaged in 12.5 oz bags. UPC: 0 36200 21215 8 Lot code: 0663 312871 and 0663 312972, Use By MAY082014 and Lot code: 0663 312971 and 0663 312972, Use By MAY092014. Class I The firm is recalling Pork & Leek Dumplings because Shrimp & Pollack Fish dumplings were inadvertently packaged in the Pork & Leek Dumpling packaging. Undeclared allergens. Conagra Inc
Devices Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System. TBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU. Class II Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU. Medtronic Vascular, Inc.
Devices Xoran Mini CT Scanner Minicat Class II A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ± 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health hazard was performed on the issue of dose rate/kVp being found outside Xoran's specifications on the MiniCAT CT Scanners. Xoran specifies that the dose rate must be within a tight range. This range is smaller than what is specified as passing by West Physics. West Physics had stated in a report "For this test, a measured effective dose of less than 0.4 mSv is considered satisfactory, and a measured does of greater than 0.23 mSv (but less than 0.4 mSv) will be investigated for possible corrective action." A scanner that falls outside the Xoran specification of 0.23 mSv does not present a danger to the patient. Xoran Technologies, Inc.
Devices MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system. Part No. 70104.8012 Serial Nos. 90410440; 90410452; 90410455; 90410456; 90410457; 90410459; 90410469; 90410474; 90410480; 904104781; 90410482; 90410484; 90410498; 90410499; 90410500; 90410501; 90410502; 90410503; 90410521; 90410522; 90410524; 90410526; 90410527; 90410531; 90410533; 90410534; 90410535; 90410550; 90410551; 90410552; 90410568; 90410571; 90410572; 90410573; 90410575; 90410576; 90410577; 90410580; 90410581; 90410582; 90410584; 90410585; 90410592; 90410596; 90410599;  ...
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Class II It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an error message with audible alarm, indicating "battery defective." The alarm will occur-upon start up or when the main power supply is unplugged from the main power source. The human machine interface touch screen of the CARDIOHELP-i device may gradually become black due to the human machine interface (HMI) back light shutting down. Maquet Medical Systems USA
Devices Xoran MiniCAT CT Scanner Minicat Class II A description of the defect in the product or the manner in which the product fails to comply wvith an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ± 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health hazard was performed on the issue of dose rate/kVp being found outside Xoran's specifications on the MiniCAT CT Scanners. Xoran specifies that the dose rate must be within a tight range. This range is smaller than what is specified as passing by West Physics. West Physics had stated in a report "For this test, a measured effective dose of less than 0.4 mSv is considered satisfactory, and a measured does of greater than 0.23 mSv (but less than 0.4 mSv) will be investigated for possible corrective action." A scanner that falls outside the Xoran specification of 0.23 mSv does not present a danger to the patient. Xoran Technologies, Inc.
Devices Xoran Minicat00202 minicat Class II The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ± 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health hazard was performed on the issue of dose rate/kVp being found outside Xoran's specifications on the MiniCAT CT Scanners. Xoran specifies that the dose rate must be within a tight range. This range is smaller than what is specified as passing by West Physics. West Physics had stated in a report "For this test, a measured effective dose of less than 0.4 mSv is considered satisfactory, and a measured does of greater than 0.23 mSv (but less than 0.4 mSv) will be investigated for possible corrective action." A scanner that falls outside the Xoran specification of 0.23 mSv does not present a danger to the patient. A copy of the health hazard evaluation may be found in ATTACHMENT 2. Xoran Technologies, Inc.
Devices Xoran Minicat00158 minicat Class II The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ± 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health hazard was performed on the issue of dose rate/kVp being found outside Xoran's specifications on the MiniCAT CT Scanners. Xoran specifies that the dose rate must be within a tight range. This range is smaller than what is specified as passing by West Physics. West Physics had stated in a report "For this test, a measured effective dose of less than 0.4 mSv is considered satisfactory, and a measured does of greater than 0.23 mSv (but less than 0.4 mSv) will be investigated for possible corrective action." A scanner that falls outside the Xoran specification of 0.23 mSv does not present a danger to the patient. A copy of the health hazard evaluation may be found in ATTACHMENT 2. Xoran Technologies, Inc.
Devices Xoran MiniCAT00202 minicat Class II The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ± 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xorans specifications. Xoran Technologies, Inc.
Devices Xoran MiniCAT CT Scanner ID ENT00001 minicat Class II Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate. Xoran Technologies, Inc.
Devices REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA) restricts the device to use by or on the order of a physician Driver, Wire and Bone Drill; The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental, orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices. 10933, 11433, 11483, 20553, 30163, 31553, 40713, 40833, 41113, 50463, 60133, 60423, 90383, 110093, 110193, 1030133, 1030403, 1040413, 2010013, 2010123, 96090403, 96091343, 97020193, 97030013, 97030543, 97050243, 97060163, 97080033, 98010083, 98020703, 98030103, 98040213, 98060023, 98061033, 98070603, 98090023, 98090473, 98090503, 98101143, 98110323, 99010433, 99030253, 99050033, 99050383, 99060163, 99060423, 99061063, 99061283, 99070453, 99071293,  ...
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Class II It was discovered that the silicone potting failed to properly cure after undergoing the prescribed curing possess. The potting material is used to insulate, stabilize and provide a moisture barrier to the TPS MicroDriver main Printed Circuit Board Assembly (PCBA). Inadequate cure of the silicone potting could potentially allow it to leak to the outside of the handpiece or cause an electrical malfunction (primarily loss of function). Two batches of silicone potting have been identified, by the supplier, as having cure properties that were outside of the specified range. Stryker Instruments Div. of Stryker Corporation
Devices Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma Coated, rHead Recon Radial Stem Plasma Coated, rHead Radial Stem 6mm Collar Plasma Coated, rHead Recon Radial Stem 6mm Collar Plasma Coated, uHead Ulnar Stem Standard, uHead Ulnar Stem 20mm Collar packaged in a sterile pouch inside a shrink-wrapped box. all item numbers and lot numbers Class II The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box. Small Bone Innovations, Inc.
Devices PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation. Model OF-B194 Class I PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user. Pentax Medical Company
Devices COULTER® LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The COULTER LH 780 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. Part Numbers: 6605362 for the LH 750 and 723585 for the LH 780. Serial Numbers: AJ08102 AK49053 AM09075 AM10078 AG05059 AK41634 AT02015 AL41189 AJ06078 AF22202 AK34502 AL02001 AS49367 AM10085 AJ10154 AM40321 AS41335 AK32475 AS30241 AU28106 AK36538 AL18073 AL18077 AL37150 AH15237 AL09039 AL09042 AK02032 AJ31547 AJ24410 AM24242 AN13074 AN13075 AN13078 AT18112  ...
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Class II Beckman Coulter internal investigation indicated that specific lots of check valves used in several locations within the LH 750 and LH 780 analyzers may fail. This failure may result in an air or liquid leak at the connection to the Vacuum Overflow Tank waste line or at the Backwash Tank drain line. Source of initial complaint: Customer laboratory in the United States. Beckman Coulter Inc.
Devices Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is intended to provide increased mobility for elderly and/or disabled person and it is also an aid to independent living. Products can be identified by their color; the recalled products are either metallic blue or metallic silver. The products have two rear wheels and have either one or two wheels in the front. The scooters have an adjustable swivel seat and a front storage basket; some scooters may be fitted with an optional larger rear basket. Serial Numbers: 10390024, 10390025, 10390029, 10390030, 10390034, 10390037, 10490100, 10490108, 10490111, 10490113, 10490119, 10490121, 10490124, 11390058, 11390060, 11390061, 11390069, 11390074, 11390095, 11390101, 11490111, 11490147, 11490176, 11490189, 11490277, 11490304, 11490305, 11490425, 11490426, 11490433, 11490435, 11490445, 12390096, 12390097, 12390098, 12390099, 12390101, 12390102, 12390103, 12390104, 12390105, 12390106, 12390107, 12390117, 12390120, 12490169, 12490170, 12490172,  ...
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Class II Breeze C Scooter, motorized 3-wheeled electric scooter for elderly people, is recalled because it may become unresponsive during operation due to an electrical contact which may fault due to extensive wear, which potentially could result in the driver not being able to stop the scooter during operation except by turning off the ignition key. S.A.E. AFIKIM
Devices Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells. ALL LOTS Class I Atossa Genetics is recalling ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT) due concerns raised by the U.S. Food and Drug Administration (FDA) in a warning letter received by Atossa in February 2013. The FDA raised concerns about (1) the current Instructions for Use (IFU); (2) certain promotional claims used to market these devices; and (3) the need for FDA clearance for certain changes made to the Nipple Aspirate Fluid (NAF) specimen collection process identified in the current IFU. Atossa Genetics, Inc.
Devices da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. model numbers 380610-04 through 38-610-14. Class II Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount. Intuitive Surgical, Inc.
Food Pectinase 3,500 ENDO-PG/G, powder, enzyme, 100 gm. Product 70A Lot ALI13157-09; re-evaluation date 12/6/2014. **sample only - not tested On 10/22/2013 American Laboratories provided CFSAN a customer distribution list for the Chloramphenicol Contamination. This spreadsheet listed the base concentrate levels. The data was highlighted: Green, Yellow, Red and Orange.The spreadsheet Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food Xylanase 150,000XU, powder, enzyme, 100 gm. Product 13A Lot ALI13157-11; re-evaluation date 12/6/2014 **sample only - not tested Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food Xylanase 10,000XU/g, powder, enzyme, 100 gm. Product 45A Lot ALI13206-05; re-evaluation date 1/25/2015 **sample only - not tested Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food Xylanase 70,000XU/g, powder, enzyme, 100 gm. Product 71A Lot ALI13206-06; re-evaluation date 1/25/2015 and Lot # ALI13008-13; re-evaluation date 7/8/2014 **sample only - not tested Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food NUT 14-500, powder, plant enzyme blend, packaged in 15 kg and 23 kg double poly bags inside fiber box. Product 98A 15 KGS: Lot ALI13212-04; re-evaluation date 1/31/2015 and 23 KGS: Lot # ALI13036-01; re-evaluation date 8/5/2104. **Lot ALI13212-04 mathmatical analysis tested "probably < 0.3 ppb in final product" **Lot ALI13036-01 mathmatical analysis tested "probably NOT < 0.3 ppb in final product" Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food PC Blend 14, powder, enzyme blend, packaged in 9 kg and 25 kg double poly bags inside fiber box. Product 62A 9 KGS: Lot ALI13249-03; re-evaluation date 3/6/2015 and 25 KGS: Lot # ALI13024-02; re-evaluation date 7/24/2014. **Lots ALI13249-03 and ALI13024-02 mathmatical analysis tested "probably < 0.3 ppb in final product" **Lot ALI13036-01 mathmatical analysis tested "probably NOT < 0.3 ppb in final product" Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food Ultra Blend 102, powder, enzyme blend, packaged in 25 kg double poly bags inside fiber box. Product 73B, SI Item # 10678. Lot # ALI13053-05; re-evaluation date 8/22/2104 **Lot ALI13053-05 mathmatical analysis tested "VERY probable NOT < 0.3 ppb in final product" Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food EB 110311-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 73C Lot # ALI13200-09, re-evaluation date 1/19/2015; Lot # ALI13140-03, re-evaluation date 11/20/2014; Lot # ALI13071-01, re-evaluation date 9/12/2014 and Lot # ALI13008-01; re-evaluation date 7/8/2014. **Lot ALI13200-09 mathmatical analysis tested "probably < 0.3 ppb in final product" **the other three lots mathmatical analysis tested "probably NOT < 0.3 ppb in final product" Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food EB 020812-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 77C Lot # ALI13200-08, re-evaluation date 1/19/2015; Lot # ALI13140-02, re-evaluation date 11/20/2014; Lot # ALI13071-02, re-evaluation date 9/12/2014 and Lot # ALI13008-02; re-evaluation date 7/8/2014. **Lot ALI13200-08 mathmatical analysis tested "probably < 0.3 ppb in final product" **the other three lots mathmatical analysis tested "probably NOT < 0.3 ppb in final product" Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food Red and Green Bell Peppers, 25 lbs. Lot # SB 7 920, SB 7 923, SB 7 924 Class I Orange County Produce, LLC is recalling fresh red and green Bell Peppers because they may have the potential to be contaminated with Salmonella. Orange County Produce
Food St. Marcellin Au lait pasteurise fabrique en Dauphine l'unite: poids net 80ge Fromagerie Qurtet 38470 VINAY Lot #13U219, Lot # 13U225 Class I The French Ministry of Food, Agriculture is requiring cheese to be withdrawn from sales at all levels of distribution as L. monocytogenes was detected in thermised (heat-treated/not pasteurized) product in France which was not exported. Epicure Food Corp.
Food 10 inch Apple Pie (baked and unbaked), NET WT 42 oz.(2 lb 10 oz), UPC 41735-22064 (unbaked) and 41735-23712 (baked), Price Chopper label. All Sell By dates from Sept 25, 2013 through Oct 9, 2013 Class II The product contains undeclared eggs. Price Chopper Supermarkets
Devices BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The following model and serial numbers are affected by this recall: Model Number: 882454 Serial Number(s): 11000021, 11000082, and 11000111. Model Number: 882482 Serial Number(s): 6000002, 6000003, 6000004A, 6000005, 6000010, 6000011, 6000012, 6000013, 6000015, 6000016, 6000017, 6000018, 6000019, 6000020, 6000022, 6000023, 6000024, 6000025, 6000026, 6000027, 6000028, 6000029, 6000030, 6000031, 6000033, 6000036,  ...
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Class II Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position. Philips Medical Systems (Cleveland) Inc
Devices Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: - Failed Back Syndrome (FBS) or low back syndrome or failed back - Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk - Postlaminectomy pain - Multiple back operations - Unsuccessful disk surgery - Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions - Peripheral causalgia - Epidural fibrosis - Arachnoiditis or lumbar adhesive arachnoiditis - Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia all serial numbers Class II Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Medtronic neurostimulators. Upon a specific set of conditions, typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended. Medtronic Neuromodulation
Devices Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. Medtronic Activa RC and Activa PC Deep Brain Stimulators are indicated for Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. Activa PC Deep Brain Stimulator is indicated for Therapy for Dystonia. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for individuals 7 years of age and older. Activa PC Deep Brain Stimulator is indicated for Obsessive-Compulsive Disorder. Bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs) all serial numbers Class II Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Medtronic neurostimulators. Upon a specific set of conditions, typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended. Medtronic Neuromodulation
Food Pringles(R) SALT & VINEGAR Potato Chips, 168 g (UPC 064100852464) and 181 g (UPC 037000230090), Pringles Manufacturing Company, 1306 Highway 70 Bypass, Jackson, TN, USA 38301-5072 All lot codes and best before dates currently on shelf of the following product, where milk is not declared on the list of ingredients Class II There was a change in Canadian labeling regulations where lactose was no longer sufficient, the label needed to stated "contains milk" Kellogg Canada Corporate Office
Devices Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated, - Failure of anticoagulant therapy for thromboembolitic disease, - Emergency treatment following massive pulmonary embolism where anticipate benefits of conventional therapy are reduce, and - Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated. 15277209 15414364 15560257 15752429 15287302 15550200 15282988 15421769 15565526 15753478 15291145 15566741 15287301 15424883 15568635 15755303 15307389 15570058 15290545 15430268 15572971 15761315 15311637 15582190 15291146 15435116 15579473 15767566 15325508 15593534 15296278 15437943 15581926 15777997 15343213 15612686 15300299 15444314 15585734 15781096 15355694 15627268 15300995 15448466 15591471 15789723 15369568 15638012 15307390 15450171 15593533  ...
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Class II Cordis identified a printing error on one unit of the Optease Vena Cava Filter, in which the orientation arrow for the femoral approach was printed in the incorrect direction. The error resulted in the filter being implanted upside down, requiring and additional percutaneous procedure to retrieve the filter. Cordis Corporation
Food the Snack Artist BBQ Flavored Potato Chips, Net Wt. 10 oz. (283 g), UPC 21130-29106. Distributed by Safeway, Inc. Pleasanton, CA 94566 Best By 08JAN2014 3255M27 Class I Undeclared Milk. BBQ flavored potato chip bags inadvertently contain Sour Cream & Onion flavored potato chips, which contain milk. Barrel O' Fun Snack Foods Co.
Food Western Nut Salt Lake City Roasted and Salted Inshell Peanuts, 6 oz (170g). Packaged in OPP (oriented polypropylene) bags. Receive bulk roasted/salted inshell peanuts from US Foods in 25 lb lined cases. Manufactured by Hampton Farms, Portales, NM for Western Nut. Lot #20013P1 Class II Western Nut is recalling certain lots of Roasted/Salted Inshell Peanuts due to unacceptable levels of Aflatoxin. Western Nut Company, Inc.
Devices Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port. 2. Model number 428080-04 All distribution from 3-15-13 to 7-19-13. Batch/Lot # S10130510 S10130325 S10130314 S10130314 S10130415 S10130426 S10130329 S10130228 S10130418 S10130304 S10130418 S10130325 S10130325 S10130408 S10130408 S10130510 S10130415 S10130304 S10130314 S10130415 S10130418 S10130228 S10130329 S10130329 S10130415 S10130426 S10130426 S10130426 S10130408 S10130325 S10130228 S10130325 S10130426 S10130426 S10130418 S10130325 S10130510 S10130408 S10130415 S10130408 S10130228 S10130304 S10130418 S10130415 S10130426 S10130314 S10130426 S10130418 S10130228 S10130228 S10130304 S10130415 S10130415 S10130418 S10130408 S10130329 S10130314 S10130228 S10130228 S10130314 S10130325 S10130415 S10130426 Batch/Lot # S10130426 S10130418 S10130408 S10130325 S10130415 S10130415 S10130415 S10130418 S10130325 S10130325 S10130329 S10130325 S10130314 S10130329 S10130426 S10130314 S10130408 S10130329 S10130426 S10130426 S10130325 S10130415 S10130426 S10130426 S10130325 S10130325 S10130325 S10130329 S10130329 S10130408 S10130415 S10130408 S10130408 S10130415 S10130415 S10130418 S10130426 S10130415 S10130325 S10130408 S10130418 Class II A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication, warnings and precautions. Intuitive Surgical, Inc.
Devices Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port. Model number 428088-12 All distribution from 3-15-13 to 7-19-13. Batch/Lot # S10130521 S10130405 S10130401 S10130405 S10130405 S10130521 S10130405 S10130405 S10130406 S10130406 S10130411 S10130411 S10130613 S10130405 S10130327 S10130327 S10130319 S10130319 S10130626 S10130703 S10130405 S10130319 S10130521 S10130613 S10130502 S10130405 S10130401 S10130406 S10130521 S10130613 S10130502 S10130406 S10130411 S10130405 S10130327 S10130412 S10130613 S10130314 S10130411 S10130327 S10130327 S10130411 S10130406 S10130613 S10130626 S10130412 S10130521 S10130405 S10130405 S10130314 S10130401 S10130411 S10130626 S10130703 S10130703 S10130703 S10130626 S10130613 S10130502 S10130401 S10130412 S10130406 Batch/Lot # S10130412 S10130405 S10130412 S10130314 S10130319 S10130502 S10130613 S10130405 S10130314 S10130405 S10130405 S10130613 S10130709 S10130703 S10130314 S10130319 S10130319 S10130314 S10130412 S10130521 S10130626 S10130411 S10130405 S10130521 S10130405 S10130319 S10130319 S10130319 S10130405 S10130405 S10130405 S10130314 S10130314 S10130314 S10130314 S10130319 S10130319 S10130319 S10130319 S10130314 S10130314 S10130314 S10130405 S10130327 S10130327 S10130405 S10130405 S10130412 S10130405 S10130327 S10130406 S10130406 S10130406 S10130613 S10130502 S10130613 S10130502 S10130521 S10130502 S10130613 S10130411 S10130502 Batch/Lot # S10130412 S10130521 S10130521 S10130521 S10130521 S10130613 S10130521 S10130405 S10130401 S10130405 S10130405 S10130613 S10130613 S10130703 S10130703 S10130319 S10130319 S10130626 S10130703 S10130405 S10130405 S10130405 S10130405 S10130521 S10130521 S10130405 S10130327 S10130406 S10130412 S10130412 S10130411 S10130401 S10130405 S10130521 S10130502 S10130406 S10130613 S10130411 S10130613 S10130613 S10130405 S10130401 S10130327 S10130405 S10130406 S10130405 S10130405 S10130405 S10130319 S10130319 S10130406 S10130406 S10130703 S10130613 S10130502 S10130412 S10130412 S10130406 S10130406 S10130521 S10130626 S10130405 S10130401 S10130412 S10130405 S10130405 S10130613 S10130502 Class II A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication, warnings and precautions. Intuitive Surgical, Inc.
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