• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Enforcement Report - Week of February 13, 2013

  • Print
  • Share
  • E-mail
-
Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Food Yangchun Noodles, 10 case, 12 bgs per case no lot number available Class II Man Fon is recalling Yangchun Noodles because they contain undeclared wheat allergen. Man Fon Inc
Biologics Red Blood Cells 8913268; 8913269; 8912432; 8912431 Class II Blood products, which tested positive for viral testing but incorrectly entered as negative, were distributed. Community Blood Center of the Ozarks
Biologics Source Plasma 06FMOC6067; 06FMOC5647 Class II Blood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells Leukocytes Reduced GT94960; GT94963 Class III Blood products, collected using equipment for which quality control was not performed, were distributed. Mississippi Valley Reg Bld Ctr
Biologics Blood and Blood Products for Reprocessing W141608611758 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. Puget Sound Blood Center and Program
Biologics Platelets Pheresis Leukocytes Reduced Irradiated W038308043344 Class II Blood product, which did not meet acceptable product specifications, was distributed. Mississippi Valley Reg Bld Ctr
Biologics Source Plasma 06DTXC0849; 06DTXC1189; 06DTXC1646; 06DTXC2014; 06DTXC2293; 06DTXC2628; 06DTXC3411; 06DTXC3766; 06DTXC4035; 06DTXC4390; 06DTXC4690; 06DTXC5204; 06DTXC5270; 06DTXC5765; 06DTXC5861; 06DTXC6363; 06DTXC6450 ;06DTXC7035; 06DTXC7189; 06DTXC7633; 06DTXC7779; 06DTXC8263; 06DTXC8437; 06DTXC8971; 06DTXC9181; 06DTXC9678; 06DTXC9913; 06DTXD0550; 06DTXD0924; 06DTXD1252; 06DTXD1630; 06DTXD1957; 06DTXD2464; 06DTXD2662; 06DTXD2982; 06DTXD3357; 06DTXD3534; 06DTXD4236; 06DTXD4606; 06DTXD5024; 06DTXD5285; 06DTXD5560; 06DTXD5714; 07DTXA0102; 07DTXA0292; 07DTXA0585; 07DTXA0853; 07DTXA1019; 07DTXA1373; 07DTXA2109; 07DTXA2371; 07DTXA2975; 07DTXA3165; 07DTXA3588; 07DTXA4655; 07DTXA4838; 07DTXA5489; 07DTXA5843; 07DTXA5991; 07DTXA6245; 07DTXB0679; 07DTXB0854; 07DTXB1215; 07DTXB1387; 07DTXB2044; 07DTXB2669; 07DTXB2914; 07DTXB4616; 07DTXB4903; 07DTXB5299; 07DTXB5874; 07DTXB6119; 07DTXB6608; 07DTXB6878; 07DTXB7365; 07DTXB8120; 07DTXB8433; 07DTXB8849; 07DTXB9179; 07DTXB9586; 07DTXC0072; 07DTXC0697; 07DTXC0928; 07DTXC5590; 07DTXC5893; 07DTXC6398; 07DTXC7081; 07DTXC7272; 07DTXC7904; 07DTXC8057; 07DTXC8925; 07DTXC9185; 07DTXC9764; 07DTXD0088; 07DTXD0439; 07DTXD0741; 07DTXD1351; 07DTXD2242; 07DTXD2579; 07DTXD3144; 07DTXD3617; 08DTXA0308; 08DTXA0663; 08DTXA1378; 08DTXA1619; 08DTXA2417; 08DTXA3093; 08DTXA3347; 08DTXA4316; 08DTXA4897; 08DTXA5228; 08DTXA5747; 08DTXA5955; 08DTXA7034; 08DTXA7373; 08DTXA8483; 08DTXA8855; 08DTXA9644; 08DTXA9931; 08DTXB0452; 08DTXB0986; 08DTXB1460; 08DTXB1980; 08DTXB2452; 08DTXB3036; 08DTXB4603; 08DTXB5259; 08DTXB6343; 08DTXB6458; 08DTXB7406; 08DTXB7673;08DTXB8366;08DTXD2764;08DTXD4245;08DTXD4951; 08DTXD5241 Class II Blood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed. BioLife Plasma Services L.P.
Biologics Red Blood Cells Leukocytes Reduced W141608044809; W141608049022. Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Puget Sound Blood Center and Program
Biologics Platelets Pooled W141608044809. Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Puget Sound Blood Center and Program
Biologics Source Plasma 037308105, 037308106, 037308107, 037308107A, 037308108, 037308109, 037308109A, 037308114A Class III Blood products, which may have been exposed to unacceptable temperatures during storage, were distributed. Talecris Plasma Resources, Inc.
Biologics Red Blood Cells Leukocytes Reduced W038308076144 Class II Blood product, labeling/crossmatch tag incorrect or missing information was distributed. Mississippi Valley Reg Bld Ctr
Biologics Red Blood Cells Leukocytes Reduced W038308075650 Class II Blood product, which did not meet the acceptable product specifications, was distributed. Mississippi Valley Reg Bld Ctr
Drugs Leukine sargramostim 5 x 500 mcg/mL vial, liquid injection, Sterile Rx only, Mfd by: Bayer HealthCare Pharmaceuticals, LLC Seattle, WA 98101 U.S. Lic. No. 1791 NDC 58468-0181-2 B18511 Exp. 04/12 , B18513 Exp. 05/12, B18515 Exp. 06/12, B18517 Exp. 06/12, B18825 Exp. 10/12, B18831 Exp.12/12 Class III Impurities/Degradation Products: A confirmed out of specification result for Leukine sargramostin lot B18827 occurred at the three month time point. Bayer HealthCare Pharmaceuticals Inc.
Devices Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion - 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7). 2.5mm Drill Bit, graduated 12mm - 26mm adjustable depth, Part Number 03.613.011 - Lots 5443576, 5522810, 5537042, 5557902 Class II Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event. Synthes USA HQ, Inc.
Devices Synthes(R) Spine Vectra, Vectra-T and Vectra-One Anterior Cervical Plating for Spinal Fusion, Adjustable Drill Stop, Part Number 03.613.012. Synthes Vectra System, Synthes Vectra-One System and Synthes Vectra-T System is intended for anterior plate and screw fixation of the cervical spine (C2-C7). Adjustable Drill Stop, Part Number 03.613.012 - Lots 5456424, 5494147, 5557938, and 5557939 Class II Although the reported incidence is low, there is the potential for the drill stop to slip on the drill bit resulting in an adverse event. Synthes USA HQ, Inc.
Drugs SLIM XTREME Herbal Slimming Capsule, supplied in 30-count bottles. Another Product Forumulated and Distributed By: Globe All Wellness, LLC Hollywood, FL 33020 www.diet66.com Inquires Call 877.842.9873 All Lots of SlimXtreme with the following format stamped in black ink on the bottom of the bottle "MFD: XX.XX.20XX EXP: XX.XX.20XX", which were manufactured overseas, are being recalled. Class I Marketed Without an Approved NDA/ANDA: Product tested positive for Sibutramine, an appetite suppressant that was withdrawn from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug. Globe All Wellness, LLC
Food Siya Pan Gilori Net Wt. 180g. Distributed by: Miami Growers Inc. 80 Broadway Jersey City, NJ 07306 T 201-985-9322, 201-369-1500 Visit us: www.miamigrowersinc.com UPC 0893056003800 UPC 0893056003800 No lot code or expiration date Class III Pan Gilori contains Red dye, 45170-Rhodamine B-Basic Violet 10 and silver leaves and other metals at high levels. Miami Growers Inc.
Biologics Bone 00511066221031, 00511066221032, 00511066221033, 00511066221034, 00511066221035, 00511066221036, 00511066221037, 00511066221038, 00511066221039, 00511066221040, 00511066221041, 03511084751013, 03511084751014, 03511084751015, 03511084751017, 03511084751021, 03511084751022, 03511084751023, 03511084751024, 03511084751025, 03511084751026, 03511084751027, 03511084751028, 03511084751029, 03511084751030, 03511084751031, 04111071021051, 04111071021052, 04111071021053, 04111071021054, 04111071021055, 04111071021056, 04111071021057, 04111071021058, 04111071021059, 04111071021060, 04111071021062, 04111071021063, 04111071021064, 04111071021065, 04111071021066, 04111071021067, 00811006631015, 00811006631016, 0081106631017, 05711068421016, 05711068421015, 04312005041024, 04312005041025, 04312005041031, 04312005041032, 04312005041033, 04312005041034, 04312005041035, 04312005041037, 04312005041039, 04312005041040, 04312005041041, 04312005041042, 04312005041043, 04312005041044, 04312005041045, 04312005041046, 04312005041047, 08211048841026, 08211048841027, 08211048841028, 08211048841029, 08211048841030, 08211048841031, 08211048841036, 08211048841039, 08211048841040, 08211048841041, 08211048841042, 08211048841032, 08211084841033, 08211048841035, 08211048841037, 08211048841038, 08211048841034, 06411024331027, 06411024331017, 06411024331018, 06411024331019, 06411024331020, 06411024331021, 06411024331022, 06411024331023, 06411024331024, 06411024331025, 06411024331026, 06411024331038, 06411024331039, 06411024331013, 06411024331036, 06411024331034, 06411024331009, 06411024331010, 06411024331011, 06411024331037, 06411024331014, 06411024331015, 06411024331016, 06411024331007, 06411024331028, 06411024331029, 06411024331030, 06411024331031, 06411024331046, 06411024331047, 06411024331040, 06411024331041, 06411024331042, 06411024331043, 06411024331035, 06411024331033, 06411024331012, 06411024331008, 06411024331049, 06411024331032, 06411024331048 Class II Human tissue allografts, not processed in a manner that prevents the introduction, transmission, or spread of communicable disease, were distributed. Musculoskeletal Transplant Foundation
Devices THERA PEARL 3-in-1 BREAST THERAPY, 2 hot and cold packs in plastic box. The Thera Pearl 3-in-1 Breast Therapy is a reusable therapeutic hot and cold pack for use with pain, swelling, engorgement, plugged ducts or mastitis associated with breast feeding or to help encourage let-down while using a breast pump. Lot Numbers 100/12/01, 116/12/01, 108/12/01, 109/12/01, 149/12/01 Class II The Spanish translation on the Instructions for Use (IFU) insert and product package for hot and cold packs has incorrect heating instructions which would cause product to over heat. Lansinoh Laboratories Inc
Veterinary Yoghund Organic Banana & Peanut Butter, Organic Frozen Yogurt for Dogs, 4-3.5 fl. oz. cups (4 pack), 14 fl. oz., (416 ml). Case: Lot Code: 26812 or earlier Cups: Best By Dates of 9.24.14 or earlier Class I Frozen dog treats recalled due to possible contamination with salmonella due to Sunland Peanut Butter recall TBD Brands
Drugs ESTEE LAUDER DayWear Sheer Tint Release, Advanced Multi-Protection Anti-Oxidant Moisturizer Broad Spectrum SPF15, All Skin types, 1.7 FL. OZ. LIQ/50 ml (tube inside a unit carton) with UPC No. 2713179904, Code WKEM-01, and 1.5 mL foil sample packets, ESTEE LAUDER, DIST., NEW YORK, N.Y. 10022 NDC 11559-008-01 A70, A80, AA0, B11, A31, A51, B51, A81, A91, A12, A22, A72, BA0, AB0, BB0, CB0, AC0, BC0, A11, A21, B21, B31, A41. Class III Failed Stability Specifications: The active sunscreen ingredient, avobenzone 3%, may not be stable over the shelf life, the sunscreen effectiveness may be less than labeled. Estee Lauder Inc
Devices Trilogy F/M Acetabular Shell without holes. Several ODs: 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. 61216907 61157229 00369603 61452214 00370029 00369698 61176450 00369643 00370031 61454835 00369732 00369699 61216908 61673516 61642322 62065259 61906448 61263152 61454836 61476896 00369630 61775736 61943339 61403525 61642325 61732773 61263539 61642324 61906449 62022702 62076908 61885843 61309789 61928501 61237709 61292681 61407876 61825843 61452216 61817457 61237707 61237708 61271325 61327754 61452215 61452217 61489313 61519975 61536413 61564182 61598285 61642323 00370315 00369632 61744558 61885845 62079957 61732772 61928502 61783457 61825844 61869694 61906453 62010604 61846487 61993146 61642326 61779030 61783460 61906450 62052790 61536692 61487482 61487481 61598295 61632192 61309790 61511677 61455839 61263540 61367254 61321073 61237710 61281183 61455840 00369649 61976102 61788120 61885847 61928503 61801103 61840614 61947562 61996712 61813950 61899040 61911390 62001304 61864069 61536693 61473713 61417315 62076907 61487483 61489314 61281184 61237711 61237712 61642328 61260584 61306613 61329094 61403527 61455843 61598296 61642327 00369605 61642329 61813945 61980779 61947563 62076909 61928504 61955589 61292682 62006523 61801104 61813948 61864070 61885848 61906451 61476897 61612715 61642330 61470887 61417316 61473724 61567576 61256570 61455841 61215903 61237713 61281185 61309791 61397913 61536694 00369645 61728663 61775735 61801102 61864071 61996713 61292684 61642332 61891249 61526509 61611815 61976103 61760310 61768196 61951207 62043439 61235829 61237714 61271326 61429593 61500680 61526508 61611819 61817458 62079956 61260587 61452212 61321074 61403528 61417317 61469130 61500681 61801101 61825845 61911391 62065258 61350519 00369738 00369635 61548179 61928505 61532294 61548180 61642333 61803766 61983681 62036846 61237716 61309792 61403529 61412049 61889258 61256571 61424318 61455846 61476898 62006522 00369803 61921682 61873604 61500682 61318326 61987182 61350520 00369741 00369702 00369639 61452213 00369640 61724206 00369705 Class II Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells. Zimmer, Inc.
Devices Trilogy F/M Acetabular Shell without holes SOLID HA. Several ODs: 38MM, 40MM, 42MM, 44MM, 46MM, 48MM, 50MM, 52MM, 54MM, 56MM, 58MM, 60MM, 62MM, 64MM, 66MM, 68MM, 70MM. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. 62245445 61633287 61709296 61633288 62252762 61843993 61992773 61761520 62215528 61398137 61338646 00115088 00115232 61403276 62167207 61371922 61807719 62005855 61330613 61490851 61514339 61761502 07892017 61268979 61278050 61278051 61338633 61354843 61384943 61622997 61693498 61730092 61780750 61831580 61581946 62109740 61227827 61645213 61461911 00113594 62252763 62016972 61930133 61236171 61499618 61693502 61926650 61962831 62049520 07892026 61268980 61330614 61371923 61398138 61449976 61490852 61581982 61603351 61629975 61639547 61748057 61772411 61801293 61831567 61851623 61366107 61278052 61278053 62084417 62185026 61227829 61338634 61658815 61476210 62245453 62056760 62030497 61761515 61236172 61366108 61403277 61566835 61596084 61813378 61860182 62011471 07892036 61203322 61268981 61278054 61278055 61281003 61338683 61360704 61371924 61419062 61449979 61490853 61581947 61622960 61633331 61737670 61784845 61831571 61962836 62180913 62078807 61227830 61645214 61476211 11000607 62011479 62042217 07891705 61603352 61278056 61338684 61366109 61769843 61831589 61973149 61236173 61268982 61278057 61278058 61333096 61371925 61514340 61633289 61791914 61813390 61860184 61946161 62084419 62245455 61429360 61645215 61227831 61384944 62270121 11000606 62049525 62005854 62159369 61680959 61851619 61596085 61792009 61236117 61268983 61278059 61278060 61338685 61366110 61371926 61639548 61819016 61398139 62011494 61670759 61950846 61603353 61278061 61419063 61490854 61761519 62126091 61843995 61622961 Class II Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells. Zimmer, Inc.
Devices Trilogy F/M Acetabular Shell with Uni-Hole. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. 61282267 61633887 61260645 61237937 61500763 61397941 61584769 61199849 61429445 61412089 00369745 Class II Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells. Zimmer, Inc.
Devices Trilogy Acetabular Shell Spiked. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. 00369642 00369648 00370032 00369656 61642334 00369644 61832805 61817455 61269936 61412631 61630564 00369407 61642337 61324694 61630563 61269937 61825837 61548181 61846490 61941029 61952408 61329095 61421263 61548182 61642336 60983133 61237717 61421264 00369660 61734272 62001310 61873606 61548185 61237808 61548184 61642338 60919315 61421260 61955590 61548186 61825841 61215919 61321081 61846488 61421258 61762005 61469142 61803767 61212922 61324695 61630550 61269940 61269941 61431735 61469143 61548190 61642339 61630567 61246475 61548191 61630565 61269943 61734270 60983134 61803771 61235835 61324696 61235836 61955591 61321084 61517446 61842609 61869695 00369695 61469149 61215920 61642341 61630551 61548201 61809017 61421267 61548199 61251222 61421266 61783461 61803769 61947736 61952415 61199836 61199839 61283453 61283454 61921683 00369661 61469151 61548205 61952422 61630552 61809012 61642342 61548206 61237809 61923871 61925091 61783462 61403530 61283455 61191067 00370048 00369663 61469152 61215929 61548212 61630569 61923872 61630553 00369638 61469154 00369651 00370752 61975586 00369664 11001720 61490760 62023765 61742082 61222252 61271664 61511137 61629985 61667049 61769838 61844002 61955479 61979981 61227814 61676615 61236278 61549718 61721127 61550409 62159365 61714399 11002260 62052850 07892033 61843998 61384952 61442061 61499614 61532992 61629982 61667062 61754419 61980115 61549720 61461917 61784734 62054500 61511139 61676596 61742071 61857680 61962840 62136223 61203311 62126090 61384953 61979983 07892046 61416489 61737672 61354833 61330560 61456504 62023767 61442060 61354834 07892052 61375761 61450049 62030472 61531423 61581705 Class II Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells. Zimmer, Inc.
Devices Trilogy Acetabular Shell with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. 00369733 00369629 61216911 61750773 61770610 61734420 61880355 61941709 61687733 61076227 61489318 61716316 61825784 62063923 61215851 61216909 61263156 61483182 61655830 61709193 61825783 61855188 61957104 61580848 61943340 62065253 62076915 61215855 61655829 61655831 61783469 61873616 61883392 61883393 61964702 61978754 61439036 61911394 62052806 61957102 61215850 61263155 61374949 61511679 61536418 61665446 61716314 61734423 61768199 61783470 61801116 61860445 61864074 61864075 61916323 61938318 61991357 61435495 62010623 61967998 62063924 61216912 61256547 61310909 61483181 61528587 61580847 61580856 61655832 61665445 61673515 61687736 61687737 61687738 61709191 61709195 61744559 61750775 61783468 61794947 61817467 61825786 61846496 61936095 61941382 61999744 61999746 62065252 61237816 61846498 61911393 62052805 61066740 61237813 61237818 61237819 61246512 61246513 61281211 61292688 61350523 61360120 61407892 61417319 61417320 61439040 61487484 61489317 61497389 61511678 61511682 61528591 61542704 61542705 61542706 61665437 61675891 61687735 61709194 61716311 61716312 61734422 61779045 61801115 61817466 61825785 61846495 61846497 61867244 61867245 61881178 61884422 61926356 61934256 61949820 61953119 61999743 61999745 61360117 61439035 61873615 61941383 61978755 62010624 61880358 61263157 61263159 61281209 61283578 61283579 61360119 61360121 61397916 61397917 61407891 61417318 61429477 61439033 61454837 61454838 61454839 61483184 61487486 61489321 61511681 61521915 61528589 61528593 61536415 61536416 61564183 61564184 61580857 61655827 61665436 61665438 61687739 61709190 61716310 61716313 61750774 61809034 61880356 61880357 61934260 61952442 61957101 62036848 62036849 62076914 61292412 61397920 61412058 61528590 61817468 61916324 61939317 61271328 61489316 61884423 61201906 61215853 61216910 61237814 61237815 61237817 61246484 61256546 61260613 61260614 61263154 61263158 61271327 61271329 61281213 61283580 61292686 61292687 61292689 61310908 61324697 61324698 61324699 61324701 61329096 61329097 61350521 61350522 61360118 61374948 61374952 61381054 61381055 61397914 61397918 61397919 61403531 61403532 61412057 61417321 61429472 61429474 61435494 61435496 61435508 61435509 61439034 61439037 61439038 61439039 61454840 61471001 61483185 61483186 61487485 61487487 61489319 61489320 61497388 61511680 61521916 61528586 61528588 61528592 61536414 61536417 61542702 61542703 61580850 61580851 61580852 61580854 61655828 61675892 61687732 61687740 61709192 61716315 61744560 61770611 61783466 61783467 61801118 61803781 61809035 61809036 61825788 61846499 61855186 61855187 61860446 61880354 61881177 61881179 61901545 61930394 61934255 61934257 61936094 62027430 62036847 62050953 62059665 62059667 62065251 61374950 61374951 61397915 00369735 61706776 61706801 00369701 61598312 62043450 62063927 62022704 61739605 61744561 61749010 61860450 61952439 62050956 62052803 61911395 61367259 61783472 62017506 61926357 61342479 61612735 61842621 61895517 62059672 62027431 61310917 61500691 61728668 61758226 61758229 61762009 61783475 61788126 61896730 61896731 61911397 61237837 61310920 61564197 61598304 61598310 61612734 61627447 61717988 61724212 61734259 61744563 61744564 61790425 61794943 61880350 61895519 61901551 61923933 61964705 62010619 62027432 62059670 62076913 61536696 62059668 61237846 61310913 61519978 61564186 61578389 61578390 61598311 61612736 61642354 61665439 61675901 61688594 61694141 61706798 61749011 61764669 61770607 61801109 61801111 61842620 61867247 61880352 61916325 61939318 61941384 61952441 61956939 61976106 61999748 62017507 62052802 62076912 61724213 62052804 61429560 62063925 61235847 61237840 61269945 61271334 61310918 61397928 61417323 61439102 61439104 61439110 61542712 61564195 61578387 61578391 61612733 61617238 61617239 61627443 61665442 61694148 61706797 61717987 61728669 61744562 61750768 61764672 61775743 61783473 61783474 61794944 61794945 61809041 61822498 61825794 61837773 61860448 61873612 61873613 61895520 61895522 61906148 61911396 61916326 61926571 61926572 61936099 61949821 61978760 61991359 62006529 62010620 62043447 61500687 61717981 61976111 61237830 61263550 61263551 61271332 61283586 61361697 61367263 61397923 61439105 61439111 61487492 61489322 61489324 61500686 61500692 61500694 61519984 61519985 61524175 61524176 61536422 61542708 61542710 61564161 61598306 61598308 61598314 61611850 61617236 61642349 61642351 61661044 61673522 61675893 61688590 61688592 61688593 61694139 61694142 61694145 61717984 61724214 61734260 61734261 61749013 61750772 61788124 61803776 61860447 61862662 61867248 61880348 61896734 61901550 61901553 61923932 61930395 61951209 61957106 61991358 62006532 62010618 62010622 62017510 61260617 61471006 61564192 61788125 61951208 61968000 62065240 62065241 61235850 61237825 61237839 61237844 61256548 61263545 61263547 61283582 61292413 61324705 61340485 61342480 61342481 61350525 61350527 61361696 61397922 61412063 61429572 61439092 61439101 61439103 61455902 61455906 61455910 61471005 61471007 61482148 61482151 61489335 61500689 61511468 61519980 61519982 61521920 61524178 61524179 61536424 61536430 61536695 61542711 61564190 61564191 61564196 61617235 61617237 61627442 61642353 61660734 61661040 61661043 61665441 61665443 61665444 61675894 61706799 61717980 61717983 61717986 61734263 61739606 61750769 61750771 61758231 61764670 61770608 61770613 61783476 61790424 61801112 61809038 61809040 61817469 61817470 61825795 61837774 61846506 61864077 61867246 61867249 61880347 61885850 61895518 61896732 61896733 61906146 61916327 61926569 61938320 61953121 61956938 61976107 61978756 61999747 62010621 61673523 61758227 61880351 62006530 61271331 61880349 61439097 61500688 61500690 61578388 61926568 62006528 61215845 61237822 61237824 61237826 61237828 61237831 61237833 61237836 61237841 61237842 61256550 61256552 61263541 61263542 61263543 61263546 61271330 61271333 61271336 61281220 61281224 61281225 61283585 61283587 61292692 61292693 61292697 61310910 61310911 61310921 61324702 61324708 61327758 61340391 61340487 61342482 61361693 61361694 61361695 61381056 61383436 61383439 61397927 61403533 61403536 61403539 61407894 61407897 61417329 61439093 61439094 61439106 61439112 61439114 61439115 61439116 61439119 61439120 61455907 61455909 61455911 61487489 61487493 61487494 61489323 61497391 61500685 61511471 61519981 61519983 61521917 61521919 61524174 61524177 61536419 61536421 61536423 61536428 61536697 61542709 61564185 61564187 61564188 61564189 61564198 61564199 61627444 61627445 61627446 61642348 61642350 61642355 61660735 61661039 61661041 61673520 61673521 61694144 61694146 61717982 61717985 61758230 61764671 61764673 61775742 61775744 61801114 61817471 61817473 61822499 61822501 61822502 61825792 61825796 61832868 61837772 61862660 61862661 61864076 61864078 61867250 61873611 61880353 61895523 61901546 61901548 61901549 61906145 61906147 61921684 61921685 61923935 61926570 61936097 61936098 61945044 61953120 61964704 61978757 62006527 62065242 61263544 61271335 61281226 61327757 61374954 61381061 61417327 61455912 61497393 61521921 61675903 61783477 61803779 61957105 61976104 62063926 61367264 61542707 61976108 61235848 61235851 61235852 61235853 61237821 61237823 61237832 61237834 61237835 61237838 61237843 61237845 61246514 61246515 61256549 61256551 61260592 61260616 61260619 61262079 61263548 61263549 61263552 61281218 61281219 61281221 61281222 61281223 61283581 61283583 61283584 61283588 61292414 61292415 61292690 61292691 61292694 61292695 61292696 61292698 61310912 61310914 61310915 61310916 61310919 61324703 61324704 61324706 61324707 61324709 61327755 61327756 61327759 61340390 61342483 61350524 61350526 61361692 61367261 61367262 61374953 61374955 61374957 61374958 61374959 61374960 61374961 61381057 61381058 61381059 61381060 61383437 61383438 61383440 61383441 61397921 61397924 61397925 61397926 61403534 61403538 61407895 61407896 61407898 61412060 61412061 61412062 61417322 61417324 61417325 61417326 61417328 61417330 61429563 61429564 61429565 61429567 61429570 61439090 61439091 61439095 61439096 61439098 61439107 61439108 61439109 61439113 61439117 61439118 61439121 61439122 61455901 61455903 61455904 61455905 61455913 61455914 61482149 61482150 61487488 61487490 61487491 61487495 61489325 61489328 61489329 61489332 61489333 61489334 61497390 61497392 61500683 61500684 61500693 61511469 61511470 61511472 61519977 61519979 61521918 61524173 61536420 61536425 61536426 61536427 61536429 61564160 61564193 61564194 61598302 61598307 61598313 61611848 61642347 61642352 61661042 61665440 61675902 61694143 61706796 61717989 61750770 61758228 61770606 61770612 61775741 61801110 61803777 61803778 61803780 61809039 61809042 61817472 61817474 61822505 61825791 61832866 61832867 61832870 61832871 61846504 61860449 61862663 61864079 61873610 61873614 61896735 61901547 61901552 61906456 61906457 61921686 61939319 61941710 61943341 61945043 61952437 61957107 61976109 62006531 62022703 61260618 61374956 61429562 61439099 61825793 61846505 61923934 61952438 62079969 62086033 62079970 62086034 61855194 61855192 62079967 62079968 61855193 61495880 00369659 61483187 61911407 61911406 61945046 61923936 61945045 61564163 62060659 61612737 61483189 61567741 61688597 62065237 62079960 61632195 61246516 62065238 61263557 61367268 61612748 61891253 61548258 61611855 61612747 61688598 61694152 62010609 62065234 62079958 61324714 61455874 61536711 61612742 61632196 62010610 61407903 61324712 61500697 61511480 61536708 61536709 61542720 61675916 61675924 61350529 61407901 61439074 61439081 61500701 61630570 61642363 61744565 61749015 61762013 61779049 61957125 61986608 62065236 61717993 62073496 61511477 61483191 61237848 61260623 61342484 61350530 61429548 61439067 61483190 61536703 61536706 61536707 61542714 61542716 61612739 61612740 61642360 61642364 61675904 61758237 61801120 61839045 61855189 61864083 61899041 61993147 62060661 61417335 61809045 61855191 61201936 61235855 61235856 61237861 61256555 61342485 61374962 61439070 61500699 61511684 61542719 61542721 61548255 61548257 61567739 61598317 61630571 61661048 61665449 61688596 61694149 61728666 61750779 61798058 61880360 61882580 61890574 61911401 62006534 62026419 61739607 61884426 62060665 61536704 61212913 61235858 61237850 61237854 61237859 61260593 61292701 61292702 61292706 61350528 61393299 61393304 61407902 61417331 61439068 61439078 61459855 61459856 61489337 61500696 61500702 61500703 61511473 61511475 61511478 61511479 61511481 61542717 61567740 61598319 61612738 61612746 61632193 61632194 61642359 61642361 61642362 61661047 61675923 61706785 61706787 61717849 61764679 61788133 61794949 61798057 61825801 61839044 61846502 61884427 61938323 61957123 61986609 62010611 62065235 61271337 61455877 61764681 61820792 61869705 61511683 61195550 61201934 61235857 61235859 61237849 61237853 61237857 61237862 61246517 61260621 61263560 61281229 61283592 61324710 61324713 61327761 61374964 61374965 61397932 61417332 61429545 61439069 61455872 61459857 61500695 61500698 61511476 61536705 61536710 61542722 61548256 61567742 61612745 61665447 61717994 61717995 61724215 61749014 61758235 61758236 61764682 61788135 61788136 61794950 61798059 61809043 61817477 61817478 61825802 61842618 61855190 61864080 61864081 61880359 61911399 61916328 61926359 61930396 61957145 62026417 62065239 61256553 61511474 61542718 61869707 61906149 62036850 62079961 61429537 61548259 61846503 61911398 61195552 61212917 61215841 61235860 61237856 61237860 61260622 61263553 61263555 61263559 61271338 61271339 61271341 61281228 61292416 61292699 61292704 61292705 61310925 61324711 61324715 61327760 61361698 61367269 61374968 61383442 61393307 61397933 61412064 61412065 61439072 61439073 61439075 61459859 61459860 61500704 61500706 61564162 61567738 61598318 61612741 61612744 61642358 61661046 61675910 61675922 61717991 61744566 61744567 61744568 61749016 61750781 61764678 61764680 61788134 61803782 61809044 61817476 61825799 61839043 61840613 61851839 61873620 61873622 61878443 61890575 61899043 61901554 61916330 61938321 61957138 61957141 61964706 61976112 61976123 62026415 62036857 61342486 61350531 61779046 61851836 61890573 61916331 62026416 61393298 61955599 61237852 61350532 61374967 61417334 61459858 61869706 61891252 61941712 61957142 61191631 61201935 61212914 61212915 61215840 61237855 61237858 61237863 61246518 61263554 61263556 61263558 61271340 61281227 61283589 61283590 61283591 61283593 61292417 61292703 61310922 61310923 61310924 61310926 61310927 61310928 61327762 61367265 61367267 61374963 61374966 61383443 61383444 61393302 61393305 61397929 61397930 61397931 61397934 61429546 61429549 61429550 61429551 61429552 61429553 61429554 61439066 61439071 61439076 61439077 61439079 61455870 61455876 61459854 61489336 61500705 61511685 61536702 61542713 61542715 61548254 61567737 61567743 61661045 61665448 61706777 61717990 61717992 61728665 61739608 61750778 61750780 61758238 61779047 61779048 61794948 61817475 61825798 61825804 61840611 61840612 61842619 61846501 61851837 61864082 61869708 61873621 61889270 61889273 61890576 61899042 61916329 61947564 61957126 61986610 62006533 62026418 62036854 62060660 62079959 61256554 61412066 61612743 61955597 61955598 00369633 61945048 61706806 61783485 61783487 61783494 61783499 61839048 61945047 61660746 61864084 62026412 61489345 62065247 61846509 61263568 61724217 61660738 61739609 61864085 61986613 62036860 61310929 61536714 61598327 61661051 61706807 62065244 61564202 62026413 62052795 61846510 61412069 61439126 61517442 61660744 61665451 61706803 61724216 61957147 61976136 61417336 61536717 61598323 61675929 61717998 61762012 61764677 61794942 62036859 61728672 61986612 62010608 61292418 61367272 61489338 61598321 61598328 61598329 61660743 61688603 61694155 61739610 61764674 61779040 61842612 61890578 61899045 61957146 61957155 61851841 61930397 61235872 61237870 61246520 61263561 61271345 61324716 61342487 61407905 61407906 61439123 61439124 61489339 61612751 61612752 61688601 61718001 61744570 61744572 61749018 61750776 61764676 61788127 61790427 61809033 61820789 61966576 61976135 62065245 62079963 61439125 61817482 61916334 62006535 62026410 61934274 61899044 61237871 61237880 61263563 61263567 61271342 61281231 61281234 61292709 61316055 61374970 61381062 61412067 61455919 61473719 61500712 61542728 61548280 61548282 61564203 61598322 61598324 61665450 61717999 61744571 61749021 61809031 61817481 61832844 61873627 61890577 61934271 61957158 61986611 62073490 62065246 62065249 61880362 61489341 61235870 61237865 61237877 61256556 61283599 61292708 61310933 61316054 61393311 61417338 61439128 61439132 61439146 61455921 61473718 61487498 61487499 61489342 61489346 61500711 61511686 61511688 61517445 61536718 61542725 61548269 61548276 61564204 61564205 61564208 61564209 61612749 61612750 61660741 61661050 61675930 61706804 61717996 61762010 61764675 61779041 61779042 61788129 61809032 61851844 61864086 61869715 61891255 62065250 62073489 61316053 61350534 61393314 61439133 61455922 61790428 62073495 62091845 61439143 62076917 61260594 61417339 61825807 61916333 61235873 61237874 61237878 61246521 61263562 61263564 61263565 61263566 61271343 61271346 61281233 61281235 61281236 61283594 61310932 61342488 61367271 61374971 61381063 61381064 61383446 61397938 61439130 61439135 61439141 61439144 61439145 61455920 61455924 61482152 61482153 61489343 61500709 61500714 61511687 61536713 61536715 61548278 61564164 61564207 61598325 61598326 61660745 61661049 61675931 61688604 61744569 61749019 61750777 61790429 61798049 61798050 61817479 61820790 61825808 61832843 61842613 61864087 61869712 61869713 61869714 61873625 61873626 61891254 61911403 61916332 61916335 61932008 61934270 61936108 62006536 62021104 62021107 62026411 62036858 62043452 62052796 62091843 61237867 61310931 61374973 61397940 61542731 61660739 61825805 62021106 61487496 61941714 61235871 61237866 61237868 61237869 61237872 61237873 61237875 61237876 61237879 61246519 61256557 61260624 61260625 61260626 61271344 61281230 61281232 61283595 61283596 61283597 61283598 61292707 61292710 61292711 61310930 61310934 61324717 61327763 61327764 61327765 61342489 61342490 61350533 61350535 61361699 61361701 61367270 61374972 61383445 61383447 61393309 61393312 61397935 61397936 61397937 61397939 61403567 61407904 61439127 61439129 61439131 61439134 61439136 61439137 61439138 61439139 61439140 61439142 61439147 61470956 61470958 61473715 61473716 61473717 61473720 61482154 61487497 61489340 61489344 61500707 61500708 61500710 61500713 61536712 61536716 61542723 61542724 61542726 61542727 61542729 61542730 61548272 61548274 61564165 61564206 61665452 61675928 61688602 61694158 61717997 61728671 61749020 61758232 61758233 61758234 61788128 61798051 61801119 61817480 61825806 61832845 61832848 61842614 61851840 61855195 61880361 61880363 61884428 61884429 61890579 61899046 61901555 61906150 61906151 61911402 61934276 61936110 61957150 61957152 61957157 61966577 61968002 62010606 62010607 62021105 61374969 61412068 61417337 61455923 61564201 61246487 00369737 00369606 61292714 61491768 61711437 61292712 61711438 61809048 61551142 61292419 61743371 61743372 61292420 61292713 61711435 61809047 61212909 61307498 61307483 61307479 61307492 61307474 61307482 61307484 61307496 61417340 61906458 61542732 62052793 61665454 61934265 62010615 61237888 61779043 61817485 61825810 61367273 61612753 61675933 61934263 61237883 61237887 61407908 61718002 62026421 62026422 61237889 61389730 61439148 61491774 61548290 61564214 61675934 61706810 61764683 62052797 61269950 61402332 61612754 61706809 61706812 61764684 61851847 61891251 61909567 61957162 61500715 61758241 61968003 61176482 61201941 61237892 61310937 61356428 61356431 61389726 61403581 61407907 61417341 61470893 61491770 61500716 61542736 61548288 61694160 61706815 61758240 61790431 61798053 61842615 61851845 61890581 61246523 61439150 62043453 61215830 61374978 61491765 61564210 61564211 61661053 61688607 61718003 61749022 61775745 61864088 61890580 61957163 62060657 61976137 61976138 61271347 61491767 61832860 61195571 61235877 61256560 61283600 61316057 61381066 61429459 61455918 61470892 61487501 61491776 61500717 61500718 61511689 61511690 61542733 61548289 61548292 61660752 61675932 61706814 61728670 61749024 61749025 61764685 61764686 61788132 61842616 61863575 61899048 61957161 62073491 61470888 61762014 61864089 61937610 61986614 61536724 62091847 61201939 61235875 61237882 61237885 61237890 61246489 61256558 61256559 61256561 61260629 61260630 61269947 61374975 61374977 61389731 61402331 61455916 61487504 61542735 61564213 61564216 61567577 61567581 61567583 61660756 61694159 61734266 61734267 61758239 61758242 61788131 61817484 61825811 61825813 61851849 61863576 61884430 61926911 61986616 62010616 61246488 61412071 61491771 61491775 61548291 61567580 61832863 61869711 62052798 61909568 61842617 61176484 61212912 61235874 61235876 61235879 61237886 61260628 61269946 61271348 61283602 61310935 61310936 61310938 61316056 61324719 61356432 61361702 61361706 61389728 61403579 61429462 61429463 61429464 61439158 61455915 61455917 61470894 61487505 61491772 61491773 61511691 61536721 61548293 61564212 61564215 61660751 61660755 61675935 61694161 61734264 61798054 61798055 61820791 61825812 61832864 61855196 61863573 61869709 61873617 61884431 61890582 61899047 61906459 61930398 61934261 61941716 61957159 62010617 62026420 62052794 62060658 62076918 61271350 61381068 61429461 61936102 62036862 62060656 62076916 61235878 61439149 61869710 61945049 61993148 61176485 61176486 61176487 61201940 61212910 61215828 61237881 61237884 61237893 61246522 61269948 61271349 61271351 61281237 61281238 61283601 61310939 61324718 61356430 61356438 61361703 61361704 61361705 61367274 61374974 61374976 61381069 61389727 61389729 61389732 61412070 61429460 61439151 61439152 61439153 61439154 61439155 61439156 61439157 61439159 61470889 61470890 61470891 61470910 61470911 61470912 61487502 61487503 61491766 61500719 61536719 61536720 61536722 61536723 61542734 61564217 61567578 61567579 61567582 61660748 61660754 61661052 61661054 61665453 61688605 61688606 61749023 61775746 61779044 61788130 61790432 61817486 61817487 61873618 61873619 61891250 61899049 61906460 61926354 61936101 61937611 61957160 61986615 61994885 61381067 61417342 61491769 61964707 00369650 61682015 61711440 61724383 61402333 61711448 61612757 61532298 61612759 61235881 61660759 61660763 61705656 61899052 61987190 61611314 61633908 61758222 61855197 61612762 61758223 61957268 61794940 62043454 61682016 61212904 61535283 61611318 61612764 61633909 61660772 61665455 61665458 61665459 61682017 61688611 61705651 61711443 61711444 61762008 61798047 61863579 61891256 61612756 61779034 61909572 61937609 61890586 61976144 61987188 62043455 61361707 61402334 61439058 61459869 61480099 61526515 61535287 61611317 61611330 61682021 61682024 61688610 61743369 61768197 61794941 61817490 61832858 61839046 61839047 61860451 61860452 61885855 61885856 61909571 61987186 61987189 62065232 61860453 61066788 61439052 61455897 61459862 61483196 61487508 61500726 61511693 61511697 61511705 61526520 61532304 61535288 61535290 61612761 61612767 61660768 61660770 61661036 61661038 61682019 61682023 61688615 61705655 61711441 61711445 61711449 61734254 61734256 61739604 61750762 61779033 61809024 61832856 61882578 61891257 61916336 61964709 61066791 61532301 61899051 62065233 61945050 61271352 61281240 61283603 61389734 61455880 61487512 61500723 61511695 61511702 61532302 61532303 61611319 61611320 61611322 61612758 61612760 61612766 61633907 61660766 61660771 61682022 61682025 61734255 61739603 61743370 61758224 61758225 61768198 61775739 61775740 61788121 61809025 61817491 61825828 61832853 61869697 61937608 61957266 61983683 61292422 61439051 61526518 61873624 62036864 61066643 61195589 61201947 61215824 61237896 61256562 61260633 61271354 61350541 61389738 61389740 61402335 61407909 61417346 61429516 61439055 61439056 61439059 61455884 61455888 61487509 61487510 61487513 61500727 61500728 61511701 61526516 61535282 61535284 61535286 61612763 61612765 61612768 61612769 61633906 61682020 61688612 61688614 61711442 61711446 61724381 61734257 61750761 61758221 61779032 61801108 61809026 61809027 61817492 61825822 61846508 61855198 61864090 61885857 61890585 61909569 61957262 61957265 61994887 61316058 61429496 61439057 61521923 61535289 61724380 61899050 61916337 61930399 61936111 61964708 61976141 62065231 61937607 61941720 61186223 61201943 61201944 61212902 61212903 61212905 61212907 61237894 61237897 61237901 61237902 61237906 61237909 61237912 61269954 61269955 61269956 61269959 61271356 61292719 61292720 61316060 61324720 61350537 61350543 61374979 61374981 61374985 61389742 61403585 61412072 61412074 61412075 61417343 61429489 61429501 61429517 61439060 61455893 61459863 61470998 61487507 61500724 61511696 61511703 61511704 61526519 61532299 61532305 61661037 61665456 61665457 61688613 61705653 61711450 61724382 61750760 61750763 61775737 61779031 61788122 61788123 61794939 61798046 61798048 61803773 61803774 61809029 61809030 61817489 61820788 61825814 61832849 61832852 61855199 61862664 61863577 61863578 61864091 61869698 61869701 61873623 61906463 61916338 61957267 61966575 61968004 61978761 61996714 62065230 61256564 61269951 61283606 61350545 61403584 61407911 61455886 61612770 61775738 61832850 61934278 61976146 61994886 62036865 62043456 61374984 61407910 61487506 61511706 61176495 61195580 61195592 61201945 61201946 61201948 61201949 61201950 61212906 61215825 61215826 61235880 61235882 61237895 61237898 61237899 61237903 61237904 61237905 61237907 61237908 61237910 61237911 61246490 61246491 61246524 61246525 61246526 61256563 61256565 61260595 61260632 61260634 61260635 61269952 61269953 61269958 61269960 61271353 61271355 61271357 61281239 61283604 61283605 61283607 61283608 61283609 61292421 61292715 61292716 61292717 61292718 61306515 61306516 61310940 61310941 61310942 61310943 61310944 61310945 61316059 61324721 61324722 61342491 61342492 61342493 61350536 61350539 61350540 61350542 61350544 61368470 61368471 61368472 61374980 61374982 61374983 61380817 61380818 61389735 61389736 61389737 61389739 61389741 61389743 61389744 61389745 61402336 61403583 61412073 61417344 61417345 61417347 61429485 61429513 61429518 61429519 61439048 61439049 61439050 61439053 61439061 61439062 61439063 61439064 61439065 61455882 61455891 61455894 61459864 61459865 61459866 61459867 61459868 61470996 61470997 61483197 61483198 61483199 61487511 61500720 61500721 61500722 61500725 61500729 61500730 61511692 61511694 61511698 61511699 61521922 61526517 61526521 61526522 61535285 61661035 61682018 61711447 61817488 61825816 61825819 61825827 61846507 61869699 61882577 61890583 61890584 61895516 61896737 61899053 61906461 61906462 61909570 61926912 61928506 61936113 61938328 61947565 61957264 61976143 61978762 61983682 61987187 61996715 61269957 61439054 61342494 62079971 62079973 62060662 62079972 61878444 00369636 61688616 61511707 61978763 61705658 61532310 61526532 61612773 61983686 62021110 61825830 61978764 61983684 61660778 61846493 61987192 61779038 61532309 61901556 61936096 61952447 61987191 62052799 61201955 61235883 61316061 61535292 61567750 61611876 61660773 61711452 61832834 61878447 61987193 61237919 61310947 61660777 61682027 61711451 61750767 61794936 61548327 61724387 61237915 61429534 61483202 61548328 61567749 61705659 61750765 61779035 61801106 61803775 61936093 61532308 61794937 61235884 61495291 61535294 61567747 61682031 61711453 61724385 61749028 61794938 61846494 61952445 61435499 61801105 62010614 61215834 61256566 61495296 61495297 61535291 61535293 61612771 61809021 61932005 62010612 62021108 62079966 61237913 61705661 61711454 61932006 62026414 61186225 61201953 61271360 61350547 61407912 61429532 61439041 61495298 61567751 61612772 61688617 61705660 61724386 61790426 61851834 61878446 61928507 62021109 61412077 61417348 61682030 61724388 61825833 61891258 61911405 61079424 61186226 61215837 61246527 61260637 61271361 61292721 61310946 61389754 61389756 61435512 61439047 61495295 61511710 61532307 61548329 61567745 61567748 61711455 61743368 61750766 61770605 61809023 61832833 61832837 61869702 61869704 61901558 61926352 61947566 61996716 62059675 62065255 61271358 61381072 61429526 61682033 61724384 61926913 62073494 61926353 61186224 61215835 61215838 61235886 61237917 61237921 61246492 61269965 61283613 61292723 61350546 61361709 61368473 61374987 61374988 61381071 61389749 61402337 61412076 61429523 61439042 61439043 61495301 61511708 61526530 61567752 61612774 61660775 61665460 61688618 61779036 61825831 61846492 61851833 61878445 61906464 61952446 61996717 61168297 61256568 61324723 61340489 61407913 61435498 61439045 61455860 61471002 61471004 61801107 61855185 61863204 61901557 61911404 62073493 61455857 61201952 61201954 61215836 61237914 61237916 61237918 61237920 61237922 61246528 61256567 61260596 61269961 61269962 61269963 61269964 61269966 61271359 61281241 61283610 61283611 61283612 61292722 61292724 61306519 61310948 61316062 61316063 61329098 61329099 61340490 61340491 61350548 61361708 61361710 61374986 61374989 61374990 61389750 61389751 61389752 61389753 61389755 61402338 61417349 61429530 61435497 61435501 61435513 61439044 61439046 61455855 61455859 61470960 61471003 61487514 61487515 61487516 61487517 61495292 61495293 61495294 61495299 61495302 61495303 61511709 61526531 61526533 61612775 61660774 61743367 61749029 61779039 61825832 61832838 61869703 61891259 61926351 61945052 62010613 62052801 62079965 61235885 61237923 61260638 61381070 61429533 00370052 00369804 61901559 61976148 61271363 61976147 61711458 61201957 61642369 61452203 61809049 61916339 61216914 61310949 61642367 61271362 61642371 61896736 62059679 61532311 61882579 61642368 61260640 61281242 61389760 61470999 61483205 61487519 61497394 61497395 61237925 61389759 61389761 61497396 61642370 61711459 61945053 61201956 61237926 61269967 61269968 61329100 61374991 61452202 61452204 61497398 61749031 61860454 61926914 61976149 61216913 61246494 61246529 61412078 61417350 61452200 61483204 61749035 61779050 61783480 61837776 61883395 61938325 61215856 61215857 61237924 61246493 61256569 61283614 61292423 61292725 61306521 61316064 61324724 61350549 61368474 61374992 61381073 61389758 61407914 61417351 61452199 61452201 61455862 61455866 61455868 61459861 61470962 61487518 61497397 61509779 61511711 61526534 61526535 61526536 61548339 61548340 61548341 61564218 61678484 61688619 61688620 61711457 61783483 61825834 61825836 61837775 61906465 61916340 61928508 62059677 61389757 61728664 00370198 00370051 00369742 00370609 00369607 61938326 61934268 61389764 61497401 61511712 61195607 61381077 61483207 61439160 61203781 61237927 61788137 61526541 61162516 61260641 61281243 61329101 61417352 61439162 61455899 61497399 61526540 61817493 61216915 61246495 61269969 61292726 61324725 61324726 61389762 61389763 61439161 61470964 61642372 62081597 00370049 00370753 00369744 00370451 61452205 00369707 61452206 61452207 61389765 61324727 61260642 61292727 00370197 00370196 00370452 00370755 00369746 00369462 61324728 00369641 61439087 61321090 61511713 00370050 00370754 00369715 61452741 61412643 61388518 00369609 61388517 00114228 00115821 11002997 61456496 62185199 07892010 61371929 61488238 61490889 62159364 61375819 61730090 62093694 62127070 62143476 61330592 61596102 61346645 61514348 61639549 61667063 61838680 07892011 61227810 61227850 61231139 61236231 61236232 61236233 61236234 61269011 61278062 61330643 61384948 61403328 61419064 61450019 61476213 61480725 61483448 61543110 61550407 61585973 61629976 61648310 61667056 61684947 61721145 61742081 61754428 61772408 61791916 61819007 61821404 61857676 61865184 61935788 61950842 61962826 61980105 61998847 62011495 62030494 62049514 62056750 62073333 61469643 00114222 00114227 00115825 11001308 61461912 61456489 07892018 07892019 61375820 62143480 62078805 62093696 62127071 62127072 62143478 61236243 61333101 61366111 61610339 61656317 07892020 61236236 61236241 61271656 61330644 61574185 61603364 61847030 61998849 61217903 61346650 61490881 61721137 62016971 07891295 07891670 07892021 61203328 61209111 61217901 61217902 61227851 61231140 61231141 61231142 61236235 61236237 61236238 61236239 61236240 61236242 61278063 61278064 61278065 61330594 61330645 61330646 61338639 61346649 61346651 61360706 61360754 61366112 61384949 61398113 61403329 61410342 61416482 61419065 61429365 61429366 61442071 61442088 61442089 61456497 61476214 61480726 61483450 61483451 61488239 61488240 61490882 61499621 61514349 61514351 61543111 61550408 61553785 61576463 61576471 61585974 61585975 61603365 61622962 61629977 61633333 61639550 61648311 61667053 61667057 61667058 61670781 61693492 61693499 61709301 61714396 61726609 61726620 61737665 61742070 61742073 61748055 61754422 61769839 61769845 61772410 61784836 61784843 61791910 61796126 61807720 61813382 61819009 61819014 61821399 61831581 61838681 61847027 61857677 61860179 61865186 61946159 61946327 61950843 61955481 61962829 61962830 61980113 61986393 61998850 62023777 62030495 62045776 62049516 62049517 62052892 62056739 62056758 62067320 62073334 61461922 61271655 61384926 61469644 61456490 61456498 00113313 00114223 11000919 11000634 11000638 11003865 61498726 61693503 62152866 62093698 62127074 07891703 61278068 61549744 62078806 62101922 62109741 62109742 62127073 61231143 61269013 61398114 61403330 61585976 61615301 61615303 61813383 07892032 61217908 61231145 61236244 61236247 61271657 61271658 61278069 61338640 61346653 61381471 61384950 61450020 61576464 61633334 61633335 61769841 61851624 61950845 61986395 07892027 07892028 07892029 07892030 07892031 61203331 61206432 61217905 61217906 61217907 61217909 61217910 61217911 61227811 61231144 61231146 61236245 61236246 61236248 61236249 61236250 61236251 61236252 61269012 61278066 61278067 61278070 61330647 61330648 61333102 61346652 61346654 61360755 61371930 61371931 61375759 61381470 61403331 61410413 61410414 61419066 61419067 61422950 61422951 61422952 61422953 61429367 61456491 61476215 61480727 61480728 61488241 61488242 61488243 61488244 61488245 61511157 61511158 61511159 61514352 61514353 61566840 61574186 61574187 61581971 61596103 61603366 61639551 61645216 61645217 61656318 61658798 61658824 61667059 61670778 61670782 61680960 61684948 61709303 61714398 61721139 61726614 61726622 61737668 61737669 61742074 61748058 61754424 61761504 61769847 61772412 61780751 61784844 61791911 61796128 61796129 61807721 61807722 61813377 61819011 61819018 61821401 61838676 61838682 61843997 61851618 61857678 61860180 61879041 61926651 61930221 61935789 61946330 61955483 61962832 61962833 61962834 61979982 61980114 61992775 61998852 62011470 62011498 62016973 62042215 62045782 62049521 62049522 62052904 62056759 62067322 62073335 61384927 61476216 61461913 61461923 61469645 00108987 07892037 61461914 61511164 61514364 61992754 62093301 62093302 62084418 62115271 62143481 62078808 62093304 62093305 62115270 62127075 62127076 62152910 61498735 61217912 61217913 61231147 61231148 61236255 61236260 61271660 61278071 61278072 61381472 61429368 61658799 61992755 62016974 07892039 61278073 07892038 07892040 61206433 61206435 61209113 61209114 61227812 61231149 61236253 61236254 61236256 61236257 61236258 61236259 61236261 61271659 61278074 61330650 61330651 61333103 61338641 61360707 61360756 61360766 61371932 61371933 61381463 61381473 61384928 61398115 61398141 61403332 61403333 61416483 61429369 61450021 61450022 61450023 61456492 61456499 61476217 61480729 61483452 61483453 61488246 61488247 61488248 61498727 61499625 61511160 61511161 61549740 61549745 61553786 61576465 61576472 61585977 61585978 61589928 61603367 61603368 61629978 61633337 61645207 61645209 61648312 61648313 61658825 61670783 61680961 61680962 61684949 61709234 61709305 61714402 61721140 61726615 61730086 61730093 61737671 61742076 61748062 61761516 61769842 61772396 61772399 61784837 61784838 61791912 61796123 61807714 61813379 61813384 61819012 61819013 61819019 61831588 61838678 61843999 61851625 61857679 61860183 61865182 61930130 61930132 61946160 61946331 61955484 61962837 61962838 61962839 61973148 61998853 62005864 62011474 62011499 62036267 62052909 62054499 62073336 61461924 61469646 61469647 62084420 62136224 62136225 62101924 61217914 61217915 61381474 62127077 61813391 61231150 61857681 62011417 07892045 61236267 61236268 61381464 61384929 61450024 61633338 61726618 62016975 61371935 07892043 07892044 61209119 61227813 61231151 61231152 61236262 61236263 61236264 61236265 61236266 61269014 61269015 61271661 61271662 61278075 61278076 61278077 61333104 61338642 61346655 61354844 61371934 61398117 61403334 61410343 61410344 61416484 61419072 61429370 61429371 61450025 61456493 61476218 61480730 61480731 61483454 61483455 61488249 61499626 61499627 61511162 61543112 61549741 61576466 61585979 61589929 61596104 61603369 61603370 61615305 61622963 61629979 61633299 61648314 61658801 61658826 61680963 61684950 61714403 61721141 61730094 61742077 61748063 61761517 61772398 61780746 61784839 61787602 61796124 61800864 61801291 61801294 61813253 61813380 61819015 61819021 61838673 61838679 61844001 61860185 61946332 61955485 61962842 61973150 61973152 61992756 61992777 61998854 62011500 62036268 62042218 62049524 62054501 62056761 62073337 61461925 61456501 61461915 00113304 00113586 61585980 62165609 61566841 61658819 61857682 62136226 62067324 61801292 62084421 62127079 62143483 62152915 61381465 62011501 61236270 61442064 61231153 61236269 61346656 61398118 61403335 61442062 61483456 61499628 61633341 62073338 07891612 07892048 61206439 61222248 61222249 61231154 61231155 61236271 61236272 61269016 61271663 61278078 61278079 61333105 61346657 61366102 61371936 61375760 61381475 61398119 61416485 61419068 61442063 61456502 61476219 61480719 61483457 61483458 61488250 61543113 61549742 61574188 61576467 61596105 61615307 61629980 61645210 61656319 61670784 61684951 61714404 61730095 61742078 61748064 61761518 61769844 61780749 61791915 61807715 61819006 61819017 61838674 61838683 61847029 61913064 61930131 61962843 61973151 61992778 62005857 62030471 62030499 62042219 62049526 61384930 61469648 00114054 00114056 61639552 61633347 61670785 61450026 61422949 62143486 62143487 62049527 62067325 61381466 61416486 61278080 61346658 61819022 61831578 07891613 07892050 07892051 61206440 61222250 61231156 61231157 61236273 61236274 61278081 61346659 61366103 61403336 61450027 61498728 61499629 61543114 61553787 61574189 61581972 61622948 61656320 61680964 61721143 61730087 61742079 61772402 61800869 61818048 61851620 61962844 62005858 62023778 00112875 61384931 61456494 61469649 00112853 11000926 00114057 61633348 62185201 61422948 62109743 62049528 07891614 61450028 61346660 61236275 61416487 61574190 07892053 61222251 61231158 61278082 61730096 61784741 61821396 61950847 62005859 61384932 61456503 61784840 61847031 61721144 07892056 07892055 61236276 61278083 61410345 61450029 61581948 61456495 61461916 61576477 07892058 00115860 61469650 Class II Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells. Zimmer, Inc.
Devices Trilogy Acetabular AB Shells with Cluster Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. Lot 61824006 61804625 61863921 61940938 61770118 61770119 61847292 62036280 62041700 62041701 62074562 61676075 61686843 61878991 62086541 07891486 61771223 61236214 61684940 61576456 61771214 61514324 62049465 61398128 61543099 61720987 61738788 61838669 61851627 61531431 61532988 61559753 61610337 61633328 61639533 61667050 61680958 61714507 61737663 61761440 61765336 61765339 61771213 61771215 61800650 61807684 61810992 61821391 61831558 61844005 61946147 61980002 61992760 62005870 62011425 62016937 62073253 62084392 61676078 61962791 62036281 61338624 61581713 61817237 61581712 61581714 61656292 61757712 61765340 61821393 61236215 61236216 61338666 61398129 61514325 61514326 61532990 61581711 61727955 61738789 61771216 61771221 61784813 61796131 61831565 61838671 61844006 61851628 61946319 61992761 61810993 61930116 62036282 61610338 61639534 61962792 61998856 62011426 61684942 61667051 62078581 61676591 61476225 61639535 62049467 61543101 61771224 61553782 61734089 62052856 61980006 61236218 61236219 61765337 61831549 62078789 61236217 61531433 61581715 61629973 61656293 61727956 61752676 61771217 61771218 61780740 61791906 61807685 61817238 61831566 61838672 61844007 61860174 62011427 62023771 62073255 61998857 61667052 61676081 61962793 61676592 61338667 61476226 61236220 61236223 61757711 61791907 61709237 61771219 61236224 61236222 61236225 61499616 61532989 61566825 61576457 61639536 61670754 61720991 61742089 61765341 61796132 61801296 61851630 61980010 61236221 61375787 61531434 61531435 61549723 61553783 61629974 61633329 61656294 61714520 61761441 61771220 61771225 61817239 61821392 61831602 61844008 61860172 62023772 61734088 61381468 61771222 61807695 62078790 61271672 61962794 61450095 61935498 62011428 61648309 61831560 61992762 61676593 61684943 61589940 61398130 62073158 62049468 62078791 61236226 61566826 61676594 62052858 61796133 61816923 61926630 61585972 61639537 61761437 61780739 61946148 61227823 61236227 61236228 61658812 61684944 61720985 61801295 61831554 61838670 61860173 61962795 61338627 62011408 61615428 61844009 62016940 61236229 61566827 61765338 61734090 61817240 61639538 61615429 61676614 61796134 77000185 77000183 61984086 61824007 61686847 77000184 07891300 61566829 61254413 61254414 61217880 62084422 61217883 61217882 61254415 62042220 61217884 61254416 61281004 61450096 61992779 61689279 61784742 61962845 61603391 61633330 61656295 61819023 61278095 61553784 61566830 61946162 61254417 62073243 61278096 61217885 61254418 61254419 Class II Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells. Zimmer, Inc.
Devices Trilogy Acetabular Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. 61567730 61558081 61611792 61559843 61567731 61611793 61215883 00369728 00369696 61930401 61459870 61611794 61564135 61201896 61292658 61783434 61915194 00369729 00369680 61921675 61638695 61915195 61906180 61808994 61425796 61580824 61471012 61263144 61201897 00369730 00370028 00370201 00370605 00370449 00369628 61996704 61779026 61533558 61758219 61455810 61452211 61911378 61596869 61734419 61783435 61794928 61201845 61783436 62055820 61580825 61825846 62022693 61580826 61638696 61889255 61263146 61281167 61321048 61329084 61471011 61638699 61896724 61921677 61283615 61309774 61215878 61216899 61638698 61855181 61906445 62052789 61374925 61638697 61199815 61199814 61403503 61412019 61486653 61521911 61533559 61580827 61633747 61817461 61921676 61957085 61263145 61412020 61470969 61486654 61809006 61292660 61237662 61374926 61452210 61528582 61837767 61873598 61930403 61945055 62006515 62052788 00370200 00369694 00370606 61732766 62063917 61374929 61454830 61360114 61500667 61808989 61996705 61734247 61635717 61640790 61920504 61716307 62022695 61215901 61949819 61215902 61397892 61486655 61580830 61635718 61779021 61882566 61638701 61709187 61884425 61201851 61271311 61374927 61454832 61483179 61533563 61761996 61783437 61825847 61832823 61957087 61957088 62038296 61803761 61846473 61873601 61999739 61425778 61439219 61455776 61528584 61533562 61580828 61638702 61640789 61750751 61846472 61878440 61528585 61783438 61945056 62055823 61281168 61283616 61292661 61368469 61439218 61454831 61486656 61533561 61542694 61542695 61580832 61580833 61640786 61640787 61820780 61846474 61860441 61895514 61941700 62063918 61397895 61454829 61709189 61842601 61860440 61867233 61911379 61216902 61263148 61263149 61269930 61271310 61283617 61309777 61374928 61397896 61412021 61497356 61533560 61564136 61580831 61611812 61638703 61716305 61761995 61803760 61808988 61867232 61906446 61921678 61947557 62022696 61825848 61939314 61216901 61260601 61292662 61309776 61329085 61340386 61342477 61374930 61397894 61403504 61455777 61455778 61455781 61489305 61497357 61521912 61580829 61580834 61640788 61709188 61732765 61744554 61750750 61779020 61842602 62036845 62055824 62063916 61412022 00369731 00370027 00368634 00369658 61454834 61867235 61640791 61716308 61957090 61580837 61716309 61867234 61542693 61928497 61734250 61215868 61215869 61246506 61564167 61350515 61260602 61263150 61271313 61528579 61770602 61779024 61967996 61808993 61820783 61895506 61283618 61500670 61536405 61580838 61638704 61770601 61794933 61794934 62017509 61360115 61321052 61901543 61216904 61237664 61246444 61360116 61439201 61476884 61822463 61860442 61911382 61957092 62022697 62055830 61216903 61263151 61580839 61873599 61397901 61237666 61309778 61397899 61403505 61425783 61439196 61439198 61439199 61476882 61528580 61542692 61580835 61638705 61734249 61750752 61768195 61837768 61882567 61911381 61916321 61943334 61947558 61199819 61237667 61271312 61292397 61292663 61309779 61324687 61329086 61397898 61412023 61412024 61439197 61454833 61470971 61471010 61476883 61476885 61476886 61500669 61528581 61536406 61536407 61580836 61638706 61762003 61846485 61939315 61941696 61945058 62055825 62055827 00369700 00369734 61215879 61237671 61580844 61901544 61732769 61957095 61980772 61761997 61397907 61263532 61749006 61809001 61911383 61926573 61996707 62022701 61911384 61627439 61790422 61867239 62036843 61926350 62027429 61237672 61403506 61500672 61524168 61627441 61717971 61749005 61761998 61896725 61957096 61978758 61980770 61980771 61638708 61916322 61215880 61237668 61417354 61511483 61511485 61542697 61542698 61542701 61580841 61638709 61678476 61717972 61717974 61750749 61790421 61864066 61896726 61896727 61383431 61867240 61327750 61839042 61957094 61627440 61309781 61367250 61439187 61439188 61439190 61482140 61524169 61524171 61536409 61536412 61580840 61717973 61732771 61788116 61794930 61825850 61842605 61842606 61867236 61867241 61882568 61949818 61999741 62017508 61435510 61580842 61996706 61999740 62022698 61256572 61292398 61292667 61350517 61374931 61407863 61439185 61439186 61470974 61482145 61500671 61524170 61536408 61542696 61542699 61564168 61638707 61638710 61678475 61744555 61775726 61775728 61779022 61822464 61825849 61846476 61846477 61855182 61882569 61926574 61926575 61930400 61939316 61999742 62022699 61327751 61350516 61425784 61822467 61867238 61941703 61215881 61237669 61237670 61246457 61246507 61246508 61260603 61263533 61263534 61271314 61271315 61271316 61281169 61281170 61283619 61283620 61292664 61292666 61309780 61321054 61361689 61374932 61374935 61374936 61383432 61397903 61397904 61397905 61397906 61407862 61412027 61417353 61425786 61435506 61435511 61439184 61439189 61439191 61439192 61470972 61482142 61482143 61482144 61482146 61486657 61486658 61486659 61486660 61489306 61497387 61500673 61511484 61536410 61536411 61580843 61724211 61770597 61775727 61846478 61895508 61906137 61945072 62079955 00369631 61822470 62043431 61790423 61952342 62043429 61612717 61955585 61980774 61980773 62060654 61825852 61567732 61761999 61486665 61564139 61632191 61783440 62006516 61500675 61564171 61976097 61486661 61744556 61783439 61987181 62010598 61885837 61941704 61486666 61536683 61536699 61564169 61612716 61675890 61739596 61775732 61921679 62006517 61256573 61367252 61439183 61486664 61511486 61536701 61638711 61717977 61739597 61749007 61846486 61869686 61911386 61638712 61281171 61374933 61429452 61435514 61486667 61511487 61536698 61678478 61717976 61770599 61809009 61895510 61397909 61407867 61439165 61536682 61762001 61825851 61191659 61260605 61263535 61292668 61292669 61309782 61342478 61374934 61397910 61397911 61412028 61435505 61439182 61500674 61564170 61860443 61873602 61891241 61911385 61951204 61327752 61439166 61598279 61920508 61263536 61435504 61186232 61191658 61201882 61201883 61211984 61211985 61237674 61271317 61271318 61283621 61292399 61309783 61383433 61417355 61439163 61439164 61486663 61536684 61564137 61564138 61564140 61717978 61820785 61832829 61851831 61869685 62038298 61439181 00369873 61896728 61739601 61640795 61536687 61237678 61517429 61633897 61640799 61744557 61891243 61500676 61976098 62060655 61598282 61633898 61966562 61564141 61598283 61640793 61640800 61775733 61820782 62006519 62052786 61306602 61439180 61598281 61846481 62010601 61869689 62006518 61899039 61813944 61383435 61076208 61271319 61374938 61486672 61500677 61511465 61564142 61564144 61640797 61779028 61783443 61846479 61928498 61941705 62021103 61783442 61246509 61256574 61281172 61292401 61292670 61383434 61403508 61407869 61412029 61417356 61425791 61439178 61486670 61511489 61536685 61536686 61564172 61739602 61775734 61803762 61851829 61885839 61980775 61439173 61439174 61511488 61564173 61640801 61846480 61951205 61955586 61237675 61237676 61237677 61260606 61263537 61263538 61283622 61309784 61309785 61321058 61327753 61329087 61350518 61374937 61403507 61407870 61439172 61439175 61439176 61439177 61439179 61473714 61482147 61486671 61489307 61511490 61564143 61564174 61640794 61640796 61640798 61762004 61839041 61869690 61891242 61911387 61920505 62052787 00369604 00369766 61734252 62036841 61292671 61292672 61307473 61307471 61439167 61980776 61996709 61941685 61271320 61976099 61511491 61640807 61895507 61350514 61417362 61598284 61640805 62094938 61439195 61564146 61564175 61567573 61775731 61820781 61839040 61846484 61891244 61920502 61367253 61638713 61536688 61536690 61640806 61739599 61882570 61808996 61885840 61911388 61237682 61199824 61439171 61473722 61536691 61779023 62076896 61794929 61869688 61920503 61439193 61407871 61212919 61215862 61283623 61389712 61402340 61412030 61476887 61476889 61476891 61567574 61717979 61941708 61350513 61439170 61201886 61318327 61374942 61491778 61536689 61564176 61638714 61640803 61739598 61808995 61996708 62052784 61237683 61832827 61191662 61212918 61237680 61237681 61246510 61260607 61269931 61281173 61281174 61318325 61321061 61374939 61374940 61374941 61389711 61425779 61439168 61439169 61439194 61473723 61489308 61491777 61564145 61567575 61638715 61640804 61762002 61775730 61851830 61869687 00369765 00369634 61642166 61642159 61642158 61891247 61952348 61612720 62060651 61851828 61526490 61964698 61611261 61612719 61996710 61803764 61511673 61526489 61532283 61611255 61612722 61642163 61808990 61487476 61820784 61983677 61292402 61374944 61724375 61532285 61237688 61439209 61489311 61532284 61642156 61711432 61885841 61389713 61837769 61906447 61271321 61567733 61611258 61612721 61633902 61638717 61642160 61837770 61891246 61869691 62021100 61271322 61374943 61439211 61486683 61489309 61511674 61521913 61535278 61567734 61638716 61642161 61642162 61732768 61734248 61749008 61920499 62036839 62060652 61341071 61439210 61201889 61237689 61260608 61389714 61412031 61417363 61425787 61439212 61486679 61489310 61535279 61564147 61724376 61724377 61732767 61743363 61783452 61846483 61864067 61869692 61911389 61920498 61952345 61964699 61980777 61996711 62060653 62076898 61283624 61403510 61471008 61567735 61899038 60750944 61186234 61201888 61201890 61235816 61235817 61237684 61237685 61237686 61237687 61246511 61256575 61269932 61269933 61281175 61292673 61292674 61292675 61309786 61309787 61321064 61329088 61329089 61341072 61389715 61389716 61407872 61425788 61425789 61425790 61439208 61439213 61455813 61455834 61455835 61480102 61486682 61487474 61487475 61611254 61611257 61612718 61633901 61638718 61743364 61770598 61775729 61783450 61794931 61808991 61837771 61851827 61921680 61953113 61955587 62010600 62021101 62050961 61403512 00369738 00369635 61548179 61928505 61532294 61548180 61642333 61803766 61983681 62036846 61237716 61309792 61403529 61412049 61889258 61256571 61424318 61455846 61476898 00369739 00370054 00369637 61882571 61638719 61983678 61758220 61292678 61439215 61509780 61788118 61932004 61642196 61864068 61895512 62010602 61564180 62021102 61476895 62043436 61611267 61389721 61407874 61425794 61439217 61526504 61564155 61817464 61883391 61920510 61201892 61216905 61237701 61532291 61642197 61199828 61269935 61271324 61321065 61321066 61329091 61389720 61439214 61439216 61476894 61500679 61526505 61564156 61612731 61642195 61794935 61813951 61425795 00370053 00369740 00370607 00369840 61329092 61489312 61983679 61928499 61878442 62010603 61389722 61564181 61612732 61452208 61511675 61564157 61642203 61788119 62027422 61201893 61292679 61407875 61452209 61532292 61642202 61321067 61216906 61425793 00370199 00370026 00370872 00369743 00370608 00369764 61564158 61459872 61186240 61471009 61611268 61329093 61283626 00369747 00370056 00370450 00370430 00369484 00369608 61487480 61511676 61318672 61321068 00370055 00370434 61564159 61459871 00369704 61168262 00369763 00369874 00369748 00369611 61450088 62245444 62155060 61375769 61384935 61461918 07892003 61784841 61442054 61490803 61553788 61622951 61676585 61693494 61730083 61761521 61821403 61384936 61456505 62255381 61498729 61791909 07892004 61236174 61227816 61269036 61278084 61278085 61333092 61375770 61410381 61442055 61480720 61490804 61531428 61549721 61553776 61596121 61622952 61648305 61676597 61684954 61714405 61730082 61737673 61754427 61384963 61416505 61559760 61456506 62143475 61231172 07892006 61236175 61730084 07892005 61222254 61231173 61271665 61403345 61442056 61480721 61490805 61532993 61553789 61596115 61615390 61639523 61648306 61676616 61693495 61748059 61784835 61865183 62073331 61469656 61384938 62136220 61456507 61499630 61761522 07892007 61498730 61857683 61684956 62093691 62126089 61206442 61821397 61231175 61236177 61422944 61615393 61610332 61843996 07891616 07891666 07891667 07892008 07892009 61222255 61231176 61231177 61236176 61236178 61236179 61269037 61271666 61278086 61403346 61419069 61419070 61422943 61422945 61442066 61490806 61490807 61532994 61532998 61550411 61550412 61559754 61581709 61585971 61629971 61629983 61645211 61648317 61658806 61676586 61680965 61693496 61709297 61721126 61730089 61742080 61754420 61772407 61807718 61955478 61962825 61973145 61986391 62011416 62016969 62042213 62054498 62073332 61384937 61384965 61456516 61469657 00113253 00114049 00114229 00115856 07892012 11001309 11001867 00108990 00113250 61680966 61498732 61498731 61714394 62115294 61389597 62078804 62084414 62115293 62115295 62136221 61222257 61456517 61227817 61442059 61831579 61278087 07892013 61222256 61236180 61236183 61236185 61236190 61419071 61490808 61629984 61658807 61676587 61684935 61693497 61865185 61962827 61980112 62067319 61236188 61389603 07891668 07891669 07892014 07892015 07892016 61222258 61222259 61227818 61236181 61236182 61236184 61236187 61236189 61236191 61236192 61269039 61271667 61271668 61278088 61338643 61346662 61346667 61389598 61389601 61389602 61403347 61410382 61416506 61416507 61416508 61422946 61422947 61442057 61442058 61450089 61480722 61480723 61480724 61490809 61490810 61490811 61531429 61532995 61532999 61543118 61550413 61550414 61559749 61559755 61566836 61574191 61574192 61581955 61589933 61596122 61610333 61610334 61615394 61622953 61622965 61639524 61645212 61648307 61656283 61667054 61676598 61693491 61709295 61709299 61714395 61721136 61726608 61730085 61730091 61737664 61742072 61748054 61748060 61754421 61754429 61761523 61772409 61791917 61796125 61813376 61819008 61821398 61831568 61847026 61851621 61860178 61955480 61962828 61973146 61986392 61992774 61998848 62011496 62016970 62042214 62049515 62052887 62056751 62056757 61456508 61389599 61389604 61461919 61469660 61469661 00108984 00114224 61574193 61684958 07892025 62093298 62084415 62084416 62101920 61360738 61227819 07892023 61278091 61680967 61721138 61726612 61333093 61442090 61553777 61847028 07891701 07891702 07892024 61206443 61222260 61236193 61236194 61236195 61236196 61236197 61236198 61236199 61236201 61269040 61271669 61278089 61278090 61333106 61349608 61354835 61354839 61354840 61366104 61375771 61375773 61375774 61410383 61429377 61429378 61442091 61442092 61450090 61476220 61498733 61498734 61543094 61559750 61566837 61581957 61589934 61589935 61610335 61615395 61622966 61639525 61648308 61656284 61667055 61676599 61693501 61714397 61730088 61737667 61748056 61754423 61769840 61769846 61796127 61819010 61831569 61865181 61986394 61998851 62011497 62052894 61469663 61389605 61389606 61456509 61461920 00109003 62215529 61222261 62136222 62185052 62101923 62030496 61236202 61236204 61349593 61375775 61680968 07891704 07892034 07892035 61227820 61236203 61269041 61271670 61278092 61333094 61338644 61354836 61354841 61354842 61360739 61366105 61389617 61403351 61450091 61450092 61476221 61559751 61576445 61589937 61589938 61622955 61639526 61656285 61676588 61709230 61714401 61726623 61742075 61754425 61769848 61796130 61821402 61860181 61962835 61992776 62255388 61389615 61456510 61461921 61354837 62093701 62159366 61366101 61236205 61589939 61622956 61680969 07892041 07892042 61206446 61222262 61236206 61236207 61271671 61333095 61349594 61349609 61375776 61410384 61450093 61553778 61566838 61656286 61726617 61754426 61791913 61819020 61962841 61986396 62030498 62245454 62262493 61456511 61476222 62241415 07892047 61360740 61476223 61222263 61236208 61269042 61330571 61349595 61410385 61450094 61566839 61596123 61656287 61721142 61780747 62262495 61456512 62257718 61800866 61354838 07892049 61236209 61278093 61338645 61403352 61610336 61693493 61456513 62255392 61360686 61813381 61236210 61476224 61403353 61278094 61222264 61236211 61366106 07892054 61456514 07892057 61456515 61203315 61269044 61236213 Class II Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells. Zimmer, Inc.
Devices Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage. 62054788 61901417 61984072 61901423 61901426 61901427 61901428 61901435 61901437 61278096 Class II Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells. Zimmer, Inc.
Drugs Carboplatin Injection, 600 mg/60 mL (10 mg/mL), 60 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, Hospira, Inc., Lake Forest, IL 60045, Product of Australia, NDC 61703-339-56. Lot #: Z021650AA, Exp. 08/2013 Class I Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. Hospira Inc.
Drugs Carboplatin Injection, 450 mg/45 mL (10 mg/mL), 45 mL, Cytotoxic Agent, Sterile, Multi-Dose Vial, Rx only, For IV Use, NDC 61703-339-50 (Hospira label) and NDC 61703-360-50 (Novaplus label), Hospira, Inc., Lake Forest, IL 60045, Product of Australia. lots Z011711AA (Hospira label) and Z011711AB (Novaplus label), Exp. 08/2013 Class I Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals. Hospira Inc.
Devices Oxoid Antimicrobial Susceptibility Test Discs, Aztreonam 30 ug, IVD, REF CT0264B, Oxoid Ltd., UK, oxoid@thrmofisher.com (Both Remel & Oxoid, Ltd are a part of Thermo Fisher Scientific) An antimicrobial susceptibility test disc is a device that consists of antimicrobic-impregnated paper discs used to measure, by a disc-agar diffusion technique or a disc-broth elution technique, the in vitro susceptibility of most clinically important bacterial pathogens to antimicrobial agents (Aztreonam). Lot 1100699 Class II The firm is recalling the product due to some cartridges may contain individual discs that are not impregnated with antibiotic. The firm notified their customers of the recall with a notification letter and requested a confirmation fax back of receipt. Remel Inc
Devices PREMIER LIFECARE RECLINER 5400 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion. Model 5400. Serial numbers: 540100017, 540100020, 540100063, 540100160, 540100161, 540100162, 540100062, 540100103, 540100104, 540100105, and 540100106. Class II The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states. Winco Mfg., LLC
Devices PREMIER CARE RECLINER 5570/5574 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion. Model 5570 and 5574. Serial numbers: 557A100080, 557A100081, 557100004, 557100008, 557100009, 557100012, 557100041, 557100042, 557100043, 557100044, 557100045, 557A100065, 557100036, 557100037, 557100038, 557100039, 557A100073, and 557100048. Class II The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states. Winco Mfg., LLC
Devices Cozy Comfort Premier Recliner 5580 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion. Model 5580. Serial numbers: 558A100057, 558100022, 558100023, 558100024, 558100025, 558100026, and 558A100075. Class II The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states. Winco Mfg., LLC
Devices Designer Care Cliner 6700/6704/6710 WITH CAL TB 133 UPGRADE PURCHASED JAN 01, 2011 TO AUGUST 20, 2012. A multi position recliner with a steel frame used primarily in clinics, hospitals, and treatment centers for recovery, dialysis, oncology, examination, infusion. Model 6700, 6704 and 6710. Serial numbers: 670A100027, 670A100028, 670A100323, 670100082, 670100083, 670A100101, 670A100021, 670A100324, 670A100325, 670A100284, 670A100242, 670100005, 670100124, 670100125, 670100181, 670100182, 670100183, 670100184, 670100185, 670100186, 670100026, 670A100004, 670A100036, 670A100037, 670A100038, 670A100039, 670A100040, 670A100041, 670A100042, 670A100043, 670A100044, 670A100124, 670A100135, 670A100138, 670A100137, 670A100278, 670A100299, 670A100308, 670A100345, 670A100365, 670A100191, 670A100243, 670A100303, 670100027, 670100193, 670A100244, 670A100245, 670A100246, 670100018, 670100022, 670100021, 670100020, 670100175, 670100176, 670100177, 670100171, 670100187, 670100188, 670100189, and 670100190 Class II The performance of the chemicals in the foam and vinyl are not consistent enough to meet the TB 133 fire protection mandate required by California and 4 other states. Winco Mfg., LLC
Biologics Blood and Blood Products for Reprocessing W036512022332; Class III Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed. LifeShare Blood Centers
Biologics Platelets Pheresis Leukocytes Reduced 22KW06774; Class II Blood product, which did not meet the acceptable product specifications, was distributed. American National Red Cross, Penn-Jersey Region
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W036809232318A; W036809232318B; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036812847654; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Red Blood Cells Leukocytes Reduced W036812401405; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Platelets Pooled Leukocytes Reduced Irradiated W036812831776; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Fresh Frozen Plasma W036812401405; W036811297334; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of South Florida, Inc.
Biologics Plasma Frozen within 24 hours (FP24) W036812499106; W036812505250; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Fresh Frozen Plasma W036812436897; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Community Blood Centers of Florida, Inc.
Biologics Blood and Blood Products for Reprocessing 06GT81779; Class III Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed. American National Red Cross The
Biologics Red Blood Cells Leukocytes Reduced W043211073742; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Blood and Blood Products for Reprocessing W043211073742; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Plasma Frozen Cryoprecipitated Reduced W043212029454; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Cryoprecipitated AHF, Pooled W043212029454; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Red Blood Cells Leukocytes Reduced W043212029454; W043211086744; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Blood and Blood Products for Reprocessing W043211086744; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Red Blood Cells Leukocytes Reduced W043211076210; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics Blood and Blood Products for Reprocessing W043211076210; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. Blood Assurance Inc
Biologics VistA Blood Establishment Computer Software (VBECS) ALL Versions of VistA Blood Establishment Computer Software (VBECS) Class II Software, with a defect or glitch, was distributed. Dept Of Veterans Affairs Office Of Information & Technology
Biologics Capture-P Indicator Red Cells, 1 x 11.5mL Lot Nos. 226183, 226184, 226185 Class III Capture-P Indicator Red Cells, with confirmed weaker than expected reactivity with the weak positive control, were distributed. Immucor Inc
Drugs Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125 mL (NDC 0270-1316-68) Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany). Lot #: 9K37791, Exp 11/12; 9L40746, Exp 12/12; 0A43705, Exp 01/13; 0C57509, 0C57521, Exp 03/13; 0E62913, Exp 05/13 Class I Presence of Particulate Matter; fibers identified as cellulose and polyvinyl Bracco Diagnostic Inc
Drugs Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany); NDC 0270-1315-67. Lot #: 9K34572, Exp 11/12; 0A43282, Exp 01/13; 0C56283, Exp 03/13 Class I Presence of Particulate Matter; fibers identified as cellulose and polyvinyl Bracco Diagnostic Inc
Devices Anspach Effort, Inc., 98-0061 MA-15C Bearing Sleeve with Removable Bur Guard. A reusable device used with dissection tools; designed for Transphenoidal and Skull base procedures. Lot number: 2000930 Class II Contact between the bur and bur guard could generate metal fragments that may or may not be visible to the surgeon and can potentially remain in the surgical site. The materials used to fabricate the bur guard are not traceable, design validation did not effectively evaluate adequate protection of adjacent tissue and inspection results for each of these bur guards were not documented. The Anspach Effort, Inc.
Biologics Blood Bank Control System (BBCS) Primary Application 5.0 - software for device. BBCS Primary Application 5.3.4, 5.3.5, 5.3.6, 5.3.7, 5.3.8, 5.4.0 and 5.4.0.1 Class III Blood Bank software, with a defect or glitch, was distributed. Blood Bank Computer Systems, Inc
Biologics Blood Bank Computer Systems (BBCS) Primary Application 5.0 - device software BBCS Primary Application 5.0, 5.1, 5.2, 5.2.1, 5.2.2, 5.3.0, 5.3.1, 5.3.2, 5.3.3, 5.3.4, 5.3.5, 5.3.6, 5.3.7, 5.3.8, 5.4.0 and 5.4.0.1 Class II Blood Bank software, with a defect or glitch possibly causing mislabeling blood products with a donor's CMV status, was distributed. Blood Bank Computer Systems, Inc
Food Canned mandarin oranges labeled in part: "WESTERN FAMILY Choice Selections Mandarin Oranges Naturally Sweet in Mandarin Orange Juice NET WT 10.5OZ (297g)***Ingredients: Mandarin Oranges, Mandarin Orange Juice. Proudly Distributed by Western Family P.O. Box 4057, Portland, OR 97208 U.S.A.***Product of China***0 15400 01241 6***" Can Code: S8 4500/01068 601 ORJ Best By Dates: NOV 14, 2014; DEC 14, 2014; DEC 15, 2014 and JAN 31, 2015 Case UPC: 100 15400 01241 3 Can UPC: 0 15400 01241 6 Class III The firm received two consumer complaints regarding chemical smell/taste and tasting like the can. As a result the firm began extensive testing of its inventory. Preliminary testing identified a contaminant was present. Further testing is pending to specifically identify the contaminant. Acme Food Sales, Inc
Devices ConMed Linvatec Biomaterials, PopLok bone Punch PKL-35M, 3.5mm Orthopedic manual surgical instrument - Bone Punch Lot 256058 Class II ConMed Linvatech recalled one lot of their PopLok bone Punch 3.5mm because the metal shaft diameter is 4.5mm when it should be 3.5mm. Linvatec Corp. dba ConMed Linvatec
Biologics Ortho Pipetter Volume Verification Kit Ortho Clinical Diagnostics a Johnson & Johnson Company 1001 US Highway 202, Raritan, NJ 08869 USA 1-800-421-3311 Product Code 937924 Product Code 937924; Lot Number 0007 Class III Ortho Pipetter Volume Verification Kit, Lot 0007, mislabeled with the incorrect expiration date, was distributed. Ortho Clinical Diagnostics Inc
Biologics Blood Grouping Reagent, Anti-e (Human Monoclonal)(IgM)(For Further Manufacturing Use) EMD Millipore Catalog Number: WD-1L-BK EMD Millipore Lot Number: WDB1101 Class III Single lot of Blood Grouping Reagent For Further Manufacturing Use, with a stability test point failure, was distributed. Millipore (UK) Ltd.
Biologics Labeled in part: ***Meningococcal***Groups A, C, Y and W-135***Oligosaccharide***Diphtheria***CRM***197***Conjugate***Vaccine***Menveo(R)***Powder and solvent for injection***NDC 46028-208-01***Rx Only***NOVARTIS***vaccines***Store refrigerated, away from the freezer compartment, at 36 degrees F to 46 degrees F (2 degrees C to 8 degrees C), protect from light***for intramuscular injection, read the package leaflet before use*** PSSWM Item Number 238361 Lot #M10135B Exp 2/18/2013 Class III Meningococcal Oligosaccharide Diphtheria Conjugate Vaccine, with lack of assurance of proper temperature maintenance during shipment, was distributed. PSS World Medical Shared Services
Veterinary WSI Pride Plus Amprolium Crumble 1.25%, packaged in a 50 lb. bag. The Product code/number is 104636. Tag is tan in color; with the lot number and product number located at the bottom of the tag just above the tag sew line. The product is labeled in parts: "***WSI Pride Plus Amprolium Crumble 1.25%***For Beef and Dairy Calves***MEDICATED An aid in the prevention and treatment of coccidiosis caused by Eimeria bovis and E. zurnii in calves***ACTIVE DRUG INGREDIENT***Amprolium (Corid) 1.25%***MANUFACTURED BY WESTERN STOCKMEN'S, CALDWELL, ID 83605*** 208-459-0777***". Lot No. 340209114-090712 The lot number consists of the first 9 digits, i.e., 340209114 and is a unique identifier. The Product code is the unique code assigned in the firm's database for this named finished feed product. The number 090712 is September 7, 2012. The tag was made on Sept. 7. This date does not reflect the actual date of manufacture necessarily, as tags are produced at the time an order is placed. In this case, the order was placed on Sept. 7th and at that time the tags were made. Class II WSI Pride-Plus Amprolium Crumble 1.25% was found to be sub-potent for Amprolium. The sample was detected of 0.9758% instead of 1.25% concentration of Amprolium. Western Stockmen's
Drugs Zicam Extreme Congestion Relief (oxymetazoline HCl) nasal gel, 0.05%, 0.50 fl. oz. (15 mL) spray bottle, Developed and distributed by Zicam LLC, Scottsdale, Arizona 85255, a wholly owned subsidiary of Matrixx Initiatives Inc, NDC 62750-005-10, UPC 7 32216 20410 0. Lot # 2J23, Exp 09/15 Class I Microbial Contamination of Non-Sterile Products: Product may be contaminated with Burkholderia cepacia. Matrixx Initiatives Inc
Biologics Standardized Mite Allergenic Extract E1204385 Class III Standardized Mite Allergenic Extract, mislabeled with the incorrect strength, was distributed. Jubilant HollisterStier, LLC
Drugs PredniSONE Tablets, USP, 10 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1473-01), b) 1000-count tablets per bottle (NDC 0143-1473-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatowntown, NJ 07724. Lot #: 69403A, 69403B, Exp 10/15; 69404A, 69405A, 69515A, 69702A, 69702B, 69703A, Exp 11/15; 69767A, 69767B, Exp 12/15 Class II Presence of Foreign Substance: Tablets are being recalled due to gray defects identified in the tablets. West-ward Pharmaceutical Corp.
Biologics Blood and Blood Products for Reprocessing 019LJ61879 Class III Bloood product, collected from an ineligible donor, was distributed. American Red Cross Blood Services Tennessee Valley Region
Biologics Cornea CN100823OD Class II Human Cornea, recovered in a manner that increased the risk of the introduction, transmission, or spread of communicable disease, was distributed. Indiana Lions Eye and Tissue Transplant Bank
Devices Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement. Catalog No. 130-3253, Serial Numbers 2479944 - 2479969 and Catalog No. 136-32-53, Serial Numbers 2479873 - 2479898. Class II Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed. Exactech, Inc.
Devices Exactech NOVATION CROWN CUP +5mm LATERALIZED LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 136-32-53. Exactech Hip Systems are indicated for use in surgery for hip replacement. Catalog No. 130-3253, Serial Numbers 2479944 - 2479969 and Catalog No. 136-32-53, Serial Numbers 2479873 - 2479898. Class II Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed. Exactech, Inc.
Devices Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to a sitting position. Model #3G, Serial numbers: 12GE003750, 12GE003554 and 12HE001766. Class II The potential exists for the wheel to rotate freely despite engagement of hub brake. Invacare Corporation
Food Mama Tere Cebada Natural Barley Flour Net Weight /Peso Neto: 12 oz (340g) Family Food Distributors Bergen Avenue Kearny, NY 07032 UPC 7412003000259 n/a Class III Mama Tere Cebada Flour contains undeclared colors Red #3 and Red #40. Family Food Distributor, Inc.
Drugs Taztia XT(diltiazem HCI extended release capsules, USP, Once-A-Day Dosage, 360 mg, 90 Capsules per bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, Distributed by: Watson Pharma, NDC 62037-700-90. Lot #: 512146A, Exp 01/31/2014 Class II Failed Dissolution Specification: Out of a specification result occurred during the 3-month stability testing. Dissolution result at the 4-hour time point was 41% (specification: 20-40%). Watson Pharmaceuticals
Devices Li-Ion battery used in the Oxus Portable Oxygen Concentrator (POC), RS-00400. Also branded as Reliability Plus byDrive. The Portable Oxygen Concentrator is intended to deliver concentrated oxygen for adult patients with chronic pulmonary diseases. part number RS-00402 Unit ID # (TS-): 001418, 001419, 001420, 001421, 001422, 001423, 001424, 001425, 001426, 001427, 001428, 001429, 001430, 001431, 001432, 001433, 001434, 001435, 001436, 001437, 001438, 001439, 001440, 001441, 001442, 001443, 001444, 001445, 001446, 001447, 001448, 001449, 001450, 001451, 001452, 001453, 001454, 001455, 001456, 001457, 001458, 001459, 001460, 001461, 001462, 001463, 001464, 001465, 001466, 001467, 001468, 001469, 001470, 001471, 001472, 001473, 001474, 001475, 001476, 001477, 001478, 001479, 001480, 001481, 001482, 001483, 001484, 001485, 001486, 001487, 001488, 001489, 001490, 001491, 001492, 001493, 001494, 001495, 001496, 001497, 001498, 001499, 001551, 001552, 001557, 001558, 001559, 001560, 001561, and 001562. Battery SN (MB-): 06625x, 06666x, 06679x, 06715x, 08335x, 06498x, 01578x, 12009x, 12010x, 00075x, 05624x, 11868x, 11855x, 11587x, 11601x, 08240x, 08336x, 06145x, 06160x, 06302x, 06305x, 08189x, 08190x, 09200x, 09562x, 09564x, 09654x, 09719x, 09720x, 09787x, 09788x, 09887x, 09902x, 09903x, 09904x, 09905x, 09906x, 09957x, 09958x, 09959x, 09960x, 09961x, 10049x, 10477x, 10478x, 10479x, 10480x, 05689x, 05690x, 05694x, 05695x, 05696x, 05727x, 07937x, 07938x, 07940x, 07941x, 08072x, 08112x, 08125x, 10358x, 11165x, 11166x, 11961x, 11027x, 08628x, 08630x, 09143x, 09144x, 09145x, 09146x, 09498x, 09888x, 09889x, 09890x, 09891x, 09983x, 09984x, 10547x, 10549x, 10550x, 01476x, 01527x, 01576x, 05630x, 08657x, 08677x, 08752x, 08753x, 08755x, 08838x, 09724x, 10237x, 10582x, 10597x, 10600x, 11252x, 11253x, 11264x, 11265x, 11266x, 11271x, 11272x, 11469x, 11472x, 11473x, 11525x, 11526x, 11527x, 11528x, 11999x, 01518x, 09212x, 10584x, 10602x, 11110x, 11426x, 11427x, 11456x, 11471x, 11478x, 11485x, 11486x, 11514x, 11518x, 11589x, 11591x, 11592x, 11593x, 05647x, 05648x, 05649x, 06646x, 06672x, 06673x, 06674x, 06675x, 06676x, 06702x, 07558x, 07637x, 07638x, 07639x, 07640x, 07641x, 07643x, 07644x, 07645x, 07663x, 07680x, 07689x, 07691x, 07697x, 07703x, 07704x, 07705x, 08257x, 08258x, 08259x, 08260x, 08649x, 08650x, 08681x, 08807x, 08808x, 08811x, 09304x, 09387x, 09388x, 09390x, 09859x, 09860x, 10089x, 10402x, 10613x, 10614x, 10616x, 05407x, 06072x, 06078x, 06080x, 06081x, 06209x, 06217x, 06226x, 06277x, 06278x, 06279x, 06299x, 06329x, 06331x, 06396x, 06432x, 06433x, 06434x, 06436x, 06442x, 06443x, 06444x, 06445x, 06446x, 06474x, 06475x, 06476x, 06481x, 06512x, 06515x, 06517x, 06518x, 06522x, 06525x, 06810x, 06872x, 06874x, 06877x, 07030x, 07112x, 07113x, 07114x, 07116x, 07154x, 07169x, 07170x, 07171x, 07173x, 07194x, 05589x, and 07749x. Class II Due to past battery inventory storage conditions and deficiencies in the maintenance procedure, it was possible that some batteries were over-discharged to point of damaging the cells. Oxus America, Inc.
Devices SeriScaffold Surgical Scaffold Product Number: SCF10X25AGEN. Surgical mesh for use in open or laparoscopic procedures. Lot Numbers: P2012040901 (US) P2011080101B and P2011090901A (Outside the US) Class II Product is dual packaged in an inner and outer pouch, the outer pouch seal may be compromised and sterility may not be assured Allergen Medical
Devices Custom Breast Biopsy Tray, Catalog # B 9-16261, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy. LOT NO. 100212 EXPIRES: 06/2013 Class II Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter. Custom Healthcare Systems, Inc.
Devices Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy. LOT NO. 60812 EXPIRES: 11 /2012 Class II Surgical procedure trays are packed with pharmaceuticals for injection that may contain particulate matter. Custom Healthcare Systems, Inc.
Devices P10 Tobii battery box (product number 510410) Product Usage - Battery pack for MyTobii P10 Device. MyTobii P10 is a portable eye-controlled communication device featuring the Tobii Eye Control system. Product Code 510410, all units. Class II Tobii ATI customers P10 external battery pack, which contains sealed lead-acid batteries, malfunctioned while recharging and produced smoke with a chemical smell. Tobii Assistive Technology, Inc.
Drugs Carisoprodol Tablets, USP, 350 mg, packaged in a) 500-count tablets per bottle (NDC 0143-1176-05) and b) 1000-count tablets per bottle (NDC 0143-1176-10), Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724. Lot #: 69364A, 69365A, and 69365B, Exp 10/15 Class II Presence of Foreign Substance: Uncharacteristic blacks spots on tablets. West-ward Pharmaceutical Corp.
Devices Diagnostic Hybrids, Inc., RhMK, Model #:49-0600, 49-0600A, 49-0102A, and 49-T075A. Culture media, used in the cultivation and amplification of viruses, such as respiratory viruses, enteroviruses, measles, and poliovirus from patient specimens. Model #:49-0600, Lot#, 491206T, 491216; Model #: 49-0600A, Lot#, -A-491206T, -A-491216, -A-491216B; Model #: 49-0102A, Lot#, -A-491206T, -A-491216 & Model #: 49-T075A, Lot#, -A-491206T, -A-491216. Class III Fungal contamination. Diagnostic Hybrids Inc
Drugs EstroGel (estradiol gel) 0.06%, contained in 50-gr metered pumps, 1.25g/pump depression, for use as physician starter samples; product is labeled in part ***Manufactured for ASCEND Therapeutics Herndon, VA 20170 by DPT Laboratories San Antonio TX 78215*** Lot Number: EHAD Exp. 07/14 Class III Defective Container: Pump head detaching from the canister unit upon removal of the overcap. Ascend Therapeutics Inc
Drugs Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tablet, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ LF01215A, Exp 02/2014 Class III Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3. Sandoz Incorporated
Devices Phillips Easy Diagnost Eleva DRF. Model Number: 706034 Product Usage: Universal Fluoroscopic Applications Serial Numbers 362600, 362601, 364209, 364210, 375245, 375850, 376439, 384396, 387492, 398185, 399440, 399621, 399623, 402409 Class II The mirror icon on the bottom of each image could be misinterpreted as a RIGHT lead marker for side indication if the image is mirrored within a PACS system. Philips Healthcare Inc.
Devices OPTIGEN Food 30; Manufactured by Hitachi Chemical Diagnostics, Mountain View, CA. Distributed by Theridiag, Cedex, France Allergen testing Catalog number: 85035. Lot number 42K283626, expiration May 31, 2013. Class III A non conformance was identified with one lot of OPTI GEN Food 30 where there is no evidence that a visual inspection was performed on one tray of coverslips, Hitachi Chemical Diagnostics Inc
Devices KODAK INSIGHT DENTAL FILM in SureSoft Packets, Size 2 Single Packet Film, Model Number IP21S, REF/Catalog Number 8118226 --- COMMON/USUAL NAME: Dental Intraoral Radiographic Film -- 20 cartons of 80 packets. Product Usage: Dental intraoral radiography Lot 2114596 (Exp. September 2014) Class III Missing symbols and manufacturing information on the clear carton label. The expiration dating symbol is missing but the expiration date is not missing. The Lot symbol is missing but the lot number is not missing. The Manufacturer symbol, name and address including country of origin are missing. All of the remaining symbols and information are on the case label. Missing information is only associated with the clear carton label. Carestream Health, Inc.
Food Annie's Homegrown Rising Crust Four Cheese Pizza. Mozzarella, Provolone, Parmesan and Romano Cheese. Certified Organic, 23.5 oz package. Product UPC: 0 13562-20001 6; Case UPC 1 00 13562 20001 3 Annie's, Inc. 1610 5th Street Berkeley, CA 94710 All product with best by dates between 09 Jan 2013 and 14 Sep 2013. Class II Annie's Homegrown was notified by their flour supplier that due to a faulty screen at the flour mill, there is the possibility of metal fragments in some of their pizza products. The USDA was also notified as some of the products fall under their jurisdiction. Annie's Homegrown Inc
Food Annie's Homegrown Rising Crust Spinach and Mushroom Pizza. Spinach, Portobello and Button mushrooms with a Garlic Parmesan cream sauce.. Certified Organic, 25.0 oz package. Product UPC: 0 13562-20005 4; Case UPC 1 00 13562 20005 1 Annie's, Inc. 1610 5th Street Berkeley, CA 94710 All product with best by dates between 09 Jan 2013 and 14 Sep 2013. Class II Annie's Homegrown was notified by their flour supplier that due to a faulty screen at the flour mill, there is the possibility of metal fragments in some of their pizza products. The USDA was also notified as some of the products fall under their jurisdiction. Annie's Homegrown Inc
Food Annie's Homegrown Rising Crust Four Cheese Pizza. Mozzarella, Provolone, Parmesan and Romano Cheese. 22.5 oz package. Product UPC: 0 13562-20007 8; Case UPC 1 00 13561 20007 5. Annie's, Inc. 1610 5th Street Berkeley, CA 94710 All product with best by dates between 09 Jan 2013 and 14 Sep 2013. Class II Annie's Homegrown was notified by their flour supplier that due to a faulty screen at the flour mill, there is the possibility of metal fragments in some of their pizza products. The USDA was also notified as some of the products fall under their jurisdiction. Annie's Homegrown Inc
Drugs Ventavis (iloprost) Inhalation Solution, 10 mcg/1 mL, Sterile, 30 Single Use Ampules per carton, Manufactured for Actelion Pharmaceuticals US, Inc, 5000 Shoreline Court, Ste 200, South San Francisco, CA 94080, NDC: 66215-302-30. Lot #: MA00AD5, Exp: 11/30/2014 Class III Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point. Actelion Pharmaceuticals U.S., Inc.
Food MET-Rx EXTREME THERMO RAGE WATERMELON DIETARY SUPPLEMENT, 8 FL. OZ. (240 mL) , Product Number 50390 (Bulk number 50389), UPC 7 86560 50389 1, Label Revision 00B --- Manufactured in the USA by MET-RX Nutrition, Inc. Boca Raton, FL 33487 Lot # 430855, Expiration Date 12/21/12; Lot # 430856, Expiration Date 12/29/12 Class III Acetobacter lovaniensis was detected in a sample of the product tested by a private laboratory. This is an issue of commercial spoilage. NBTY Inc.
Food PURE PROTEIN PROTEIN SHOT 25g PROTEIN, GRAPE Flavor PROTEIN DRINK 2.9 fl. oz. (86 mL), Product Number 50451, Bulk Number 36753 (Vial), UPC 7 49826 50451 3 (Vial), and Product Number 50452, Bulk Number 36753 (Carton of 6), UPC 7 49826 50452 0 (Carton). --- Carefully Manufactured by Worldwide Sport Nutritional Supplements, Inc. Bayport, NY 11705 Lot # 406844, Expiration Date 04/03/2013; Lot # 439941, Expiration Date 07/26/2013; Lot # 445206, Expiration Date 10/31/2013; Lot # 456438, Expiration Date 11/30/2013 Class III Lactobacillus plantarum and Lactobacillus brevis were detected in a sample of the product tested by a private laboratory. This is an issue of commercial spoilage. NBTY Inc.
Devices Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur in order to create space for the femoral stem during a hip replacement surgery. Lot/Unit Codes: 075023, 075064, 084000, 084001, 084326, 084743, 084815, 085202, 085455 Class II The tip of the Quadra Trial Broach size 0, broke during a surgery. Medacta Usa Inc
Devices Sybron Endo Lightspeed: LSX Files, 25MM, Part Numbers: 835-2525; LSX Files, 25MM Assorted Kit, Part Numbers: 835-2455; LSX Files, 30MM, Part Numbers: 835-2031. An engine-driven rotary endodontic instrument used during endodontic procedures for cleaning and shaping the root canal. Part # 835-2525, Lot # 091274189. Part # 835-2455, Lot # 091272054, 091279295, 101200609, 101200610, 101200612. Part # 835-2031, Lot # 091268204. Class II The length markings on the Lightspeed LSX files were wrong. Ormco/Sybronendo
Food Dried Preserved Plum packaged in clear 4.4 lb (1904 g) plastic packages. The product comes in bulk form in a brown corrugated box with 10 x 4.4 lb packages. Net weight of one case is 44 lbs.. Product information is provided on the case with product name "Dried Preserved Plum" and Net Weight 44 lbs. (Product was destroyed and photos of product are not available). Distributed by Nuera Trading Company Inc., San Leandro, CA. Manufactured by Zi Jing Yuk Hin Enterprises, Guangdong, China. No code information Class II California Department of Public Health sampled Dried Plum Preserves in 4.4 lb packages and found it to contain lead at 1.5 and 1.6 ug/g. Nuera Trading Company Incorporated
Drugs Lansoprazole Delayed-release Capsules, USP, 30 mg, 500-count capsules per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India, NDC 0378-8030-05. Lot #: 1110829, Exp 05/14 Class II Presence of Foreign Tablets/Capsules: Bottles of lansoprazole 30 mg delayed-release capsules may contain topiramate 100 mg tablets. Mylan Pharmaceuticals Inc.
Drugs Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward Pharm. Corp., Eatontown, NJ 07724, Packaged and Distributed by: Stat Rx USA, NDC 42549-521-90. A02568, Exp 01/16 Class III Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled with an expiration date of 10/16 instead of 01/16. Stat Rx USA
Food Vietnamese Cinnamon Extra Fancy, product code 43200, Penzeys Spices, Wauwatosa, WI 53222. to be completed 1454800 Class II Penzeys received a complaint from a customer who found pieces of glass in bulk Vietnamese Cinnamon. Penzeys LTD
Food Imperial Nuts and Snacks Chocolate and Peanut Platter. Packed By: Star Snacks CO., LLC, Jersey City, NJ 07305. Net Wt. 26 oz (737 g) UPC 5351946762. Lots 20I272 and 19I276. Class II Imperial Nuts & Snacks brand of Chocolate and Peanut Platter (Net Weight 26 ounces) has undeclared FD&C colors Blue #1, Red #40, Yellow #5 and Yellow #6. Star Snacks Co., Llc.
Food Outer Cardboard Container - China Products Fresh Dried Cabbage. Plastic Bag: Double Swallow Brand, Net Wt 0.15 Kg (529 OZ), Dehydrated Cole, Jiangmen Native Produce Import & Export Company of Guangdong China. All codes. Class II The product contains undeclared sulfites (as a preservative). Tristar Food Wholesale Co Inc
-
-