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U.S. Department of Health and Human Services

Enforcement Report - Week of November 6, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Red Blood Cells Leukocytes Reduced 06GS92453 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. American National Red Cross, The
Biologics Red Blood Cells Leukocytes Reduced 007GF08682, 007GF08684, 007GF08679, 007GF08683, 007GF08685, 007GF08686, 007GF08691, 007GF08700, 007GF08702, 007GF08687, 007GF08688, 007GF08694, 007GF08695, 007GF08701, 007GF08699, 007GF08689, 007GF08697 Class II Blood products, collected from donors whose hemoglobin determination was performed using expired microcuvettes, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 007FE44669, 007FE44667, 007FE44666, 007FE44663, 007FE44662, 007FE44661, 007FE44660, 007FE44659, 007FE44657, 007FE44656 Class III Blood products, collected using scales for which the quality control results were not documented, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced Irradiated 06KK04287, 06KK0428806, KK04193, 06KK04267, 06KK04130 Class III Blood products, in which quality control and distribution of products did not meet specifications, were distributed. American National Red Cross (The)
Biologics Platelets Pheresis Leukocytes Reduced 06KK04290, 06KH10582, 06KK04291, 06KK04130 Class III Blood products, in which quality control and distribution of products did not meet specifications, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 06GK20836 Class II Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Recovered Plasma 06GK20836 Class III Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Source Plasma 0230124137, 0230124642, 0230125300, 0230125851, 0230126581, 0230128020, 0230128531, 0230129104, 0230129657, 0230130244, 0230130860, 0230131470, 0230132051, 0230132569, 0230133157, 0230133666, 0230134222, 0230134805, 0230135449, 0230135976 Class II Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed. Biomat USA, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced FZ68866; LT17247; FZ69538 Class II Blood products, which quality control and distribution of products did not meet specifications, were distributed. Tri-counties Blood Bank
Biologics Red Blood Cells Leukocytes Reduced 042S19211 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. American National Red Cross (The)
Biologics Platelets Leukocytes Reduced 042S19211 Class II Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed. American National Red Cross (The)
Biologics Red Blood Cells 01KH81493;01KH81496;01KH81499;01KK05209;01KK05214;01KX84353;01KX84355;01KX84356;01KX84358;01Q76121;01Q76123;01Q76124;01Q76128;01Q76129;01Y56415;01Y56417;01Y56419;01Y56421;01KH81504;01KH81503;01KH81501;01KH81500;01KH81498;01KH81497;01KK05212;01KK05208;01KK05204;01KK05203;01KH81502;01Y56420;01Q76127;01KX84354;01KX84352;01KF85597;01KF85596;01Y56423;01Q76131;01Q76130;01Q76126;01KX84357;01KX84351;01KX84348;01KX84347;01Y56422;01Q76125;01Q76132;01KK05206;01KK05207;01KH81495 Class III Blood products, not prepared in accordance with specifications, were distributed. American National Red Cross (The)
Biologics Red Blood Cells GS73316, GS73318, GS73305 Class III Blood products, which may have reached an unacceptable temperature during shipment, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Liquid Plasma GS73318 Class III Blood products, which may have reached an unacceptable temperature during shipment, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Red Blood Cells Leukocytes Reduced GQ58593, GP16828, GW67707, GW67697, GP16214, GP16225, GP16217, GP16216, GZ02392, GZ02376, GZ02394, GZ02427, GZ02426, GQ57036, GQ57037, GQ57034, GQ57040, GZ02413, GQ57047, GQ57044, GP12805, GP16152, GP16144, GP15223, GZ02059, GZ02064, GP14150, GP14774, GP14149, GP06096, GP16294, GP16254, GP16252, GP16285, GP16251, GP16256, GP16289, GP06105, GP06101, GP06098 Class III Blood products, which may have reached an unacceptable temperature during shipment, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Red Blood Cells (Apheresis) KP77163; KP77163 Class II Blood products, possibly air contaminated, were distributed. San Diego Blood Bank
Biologics Red Blood Cells 103337722 Class III Red Cell product, lacking a proper visual inspection for clots, was distributed. Blood Systems, Inc.
Biologics Red Blood Cells, codes: RC6, RC6LV, RC5 GS95665 GS95670 GS95674 GS93565 GS93572 GS85540 GS85539 GS95665 GS95670 GS95674 GS93565 GS93572 GS85540 GS85539 GS93568 GS93566 GS93564 GS93567 GS95675 GS95673 GS93570 GS95678 GS93574 GS93573 GS95677 GS93838 GS93837 GS93568 GS93566 GS93834 GS93564 GS93567 GS95675 GS95673 GS93570 GS93569 GS95678 GS93574 GS93573 GS95677 GS93838 GS93837 GS93835 GS93569 GS93835 GS93571 GS93571 GS67306 GS50734 GS62284 GS62287 GS67344 GS67895 GS32722 GS32726 GS50725 GS50726 GS50727 GS50728 GS50729 GS62283 GS62285 GS62295 GS62355 GS67298 GS67300 GS67304 GS67336 GS67560 GS67562 GS67858 GS69377 GS69391 GS69394 GS74669 GS62286 Class III Blood products, which exceeded time limits taken out of storage for labeling, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Red Blood Cells Leukocytes Reduced, codes: LRC6, LRC5, LRC3 GX94804 GW62803 GW62801 GX94808 GW62805 GX94803 GQ54219 GQ54221 GX94794 GX94799 GX94795 GX94790 GX94757 GX94758 GX94751 GX94760 GX94755 GX94763 GX94752 GX94767 GX94764 GX94768 GX94749 GX94761 GX94769 GX94754 GQ54034 GQ54017 GQ54016 Y96446 Y96451 GQ54217 Y96439 Y96442 Y96409 Y96422 Y96420 GY09002 GW79371 GW79385 GW79386 GW79382 GW79375 GW79376 GW79373 GY09002 GW79371 GW79385 GW79386 GW79382 GW79375 GW79376 GW79373 Y99056 Y99045 GC01624 GW79641 GW79640 GC01624 GW79641 GW79640 GN84524 GN84517 GN84526 GN84515 GN84529 GN84521 GN84525 GN84530 GN84520 GN84518 GN84522 GN84519 GN84523 GN84516 GQ54032 GQ54033 GQ54038 GQ54035 GQ54036 GQ54037 GQ54014 GQ54009 GQ54010 GQ54013 GQ54011 GQ54012 GN85176 GN85025 GN85180 GN85171 GN58184 GN85174 GN85181 GN85026 GN85024 GN85028 GN85029 GN85020 GC00015 GC00017 GP99721 GC00011 GP99719 GP99711 GP99714 GP99712 GP99707 GP99713 GP99709 GP99718 GP99706 GP99717 GP99720 GP99710 GP99708 GC00012 GC00007 GC00003 GC00010 GC00005 GC00004 GC00001 GC00008 GC00006 GC00009 GC00002 GC00965 GC00968 GC00961 GC00962 GC00963 GC00970 GC00972 GC00974 GC00966 GC00967 GW79365 GW79370 GW79367 GW79380 GW79377 GW79374 GW79378 GW79379 GC00015 GC00017 GP99721 GC00011 GP99719 GP99711 GP99714 GP99712 GP99707 GP99713 GP99709 GP99718 GP99706 GP99717 GP99720 GP99710 GP99708 GC00012 GC00007 GC00003 GC00010 GC00005 GC00004 GC00001 GC00008 GC00006 GC00009 GC00002 GC00971 GC00965 GC00968 GC00961 GC00962 GC00963 GC00970 GC00972 GC00974 GC00966 GC00967 GW79365 GW79367 GW79370 GW79380 GW79377 GW79374 GW79378 GW79379 GW65933 GW65996 GW65991 GQ57357 GW65988 GQ57355 GQ57356 GW65995 GQ57359 GQ57360 GW65992 GW65994 GW65989 GQ57358 GW65990 GP03563 GP03564 GP03571 GP03566 GP03578 GP03574 GX99640 GX99651 GX99641 GX99648 GX99649 GX99647 GP03514 GP03510 GP03513 GP03502 GP03507 GP03516 GP03503 GP03508 GP03534 GP03535 GP03547 GP03504 GP03506 GP03511 GP03509 GP03518 GP03505 GW79644 gc01621 GW79639 GC01625 GW79638 GW79643 GC00976 GC01623 GC01617 GC01622 GC01615 GC01616 GW79637 GC00975 GC00978 GC01620 GC01613 GC00977 GW79644 GC01621 GW79639 GC01625 GW79638 GW79643 GC00976 GC01623 GC01617 GC01622 GC01615 GC01616 GW79637 GC00975 GC00978 GC01620 GC01613 GC00977 GN82874 GN84453 GN84454 GN84455 GN84458 GN84459 GN84462 GN84465 GN84467 GN84470 GN84471 GN84472 GN84473 GN84475 GN84476 GN84478 GN84479 GN84713 GN84714 GN84726 GQ54191 GQ54192 GQ54193 GQ54196 GQ54197 GQ54198 GQ54199 GQ54201 GQ54202 GQ54203 GQ54205 GQ54206 GS78984 GX64829 GX94726 GX94734 GX94737 GX94738 GX94739 GX94742 GX94770 GX94772 GX94774 GX94775 GX94777 GX94778 GX94781 GX94782 GX94783 GX94784 GX94785 GX94786 GX94788 GX94789 GX94791 GX94821 GX94822 GX94823 GX94826 GX94827 GX94830 GX94832 GX94834 GX94835 GX94836 GC06867 GC06868 GC07174 GC07182 GC08141 GC08142 GC08145 GN79602 GN82665 GN82666 GN82667 GN82668 GN82669 GN82670 GN82671 GN82672 GN82673 GN82674 GN82675 GN82676 GN82677 GN82678 GN82708 GN82711 GN82723 GN82724 GN82725 GN82726 GN82727 GN82728 GN82729 GN82730 GN82731 GN82732 GN82733 GN82734 GN82735 GN82736 GN82737 GN82738 GN82739 GN82866 GN82867 GN82869 GN82870 GN82871 GN82873 GN83293 GN83320 GN83540 GN83541 GN83542 GN83543 GN83544 GN83545 GN83546 GN83547 GN83548 GN83551 GN83552 GN83553 GN84626 GN84627 GN84628 GN84629 GN84630 GN84710 GN84711 GN84717 GN84718 GN84722 GN85298 GN85299 GN85300 GN85303 GN85305 GN86007 GN93248 GN93249 GN93720 GN93721 GN93722 GN93723 GN93726 GN93727 GN93728 GN93730 GN93731 GN93732 GN93734 GN94514 GN94516 GN95082 GN99362 GN99748 GN99892 GN99893 GP00527 GP00530 GP00531 GP00537 GP00539 GP00540 GP01124 GP01368 GP01388 GP02078 GP03060 GP03073 GP03075 GP03179 GP03244 GP06343 GP06348 GP06359 GP07118 GP07119 GP07124 GP07586 GP07618 GP07787 GP07800 GP07808 GP08123 GP08124 GP08125 GP08535 GP09132 GP09133 GP09217 GP09232 GP15040 GP15602 GP15604 GP15701 GP15715 GP15742 GP15920 GP15926 GP15933 GP16938 GP16949 GP16965 GP16975 GP16995 GP17019 GP17263 GP17281 GP17282 GP17287 GP17494 GP17714 GP17997 GP17998 GP17999 GP18000 GP18473 GP18851 GP18852 GP18853 GP18854 GP18855 GP18856 GP18857 GP18858 GP18859 GP18860 GP18861 GP18862 GP18863 GP18864 GP19120 GP19124 GP19125 GP19216 GP19235 GP19236 GP19239 GP19240 GP19242 GP19244 GP19245 GP19246 GP19247 GP19248 GP19249 GP19289 GP19291 GP19428 GP19768 GP19769 GP19771 GP19772 GP19773 GP19774 GP19775 GP19776 GP19777 GP19778 GP19779 GP19780 GP19781 GP19782 GP19860 GP20649 GP20650 GP20651 GP20652 GP20654 GP20655 GP20656 GP20658 GP20659 GP20686 GP20687 GP20688 GP20690 GP20699 GP21284 GP21346 GP21362 GP21363 GP21403 GP21404 GP21405 GP21406 GP21407 GP21408 GP21409 GP21410 GP21413 GP21414 GP21415 GP21416 GP21417 GP21418 GP21419 GP21420 GP21421 GP21422 GP21423 GP21424 GP21425 GP21426 GP21427 GP21428 GP21429 GP21468 GP21471 GP21656 GP21676 GP21678 GP21679 GP21680 GP21681 GP21683 GP21685 GP21686 GP21687 GP21688 GP21689 GP21690 GP22325 GP22642 GP22643 GP22644 GP22645 GP22646 GP22647 GP22648 GP22649 GP22650 GP22651 GP22656 GP22657 GP22658 GP22659 GP22660 GP22661 GP22663 GP22664 GP22665 GP22666 GP22668 GP22669 GP22670 GP22859 GP22860 GP23001 GP23002 GP23003 GP23005 GP23007 GP23008 GP23009 GP23010 GP23011 GP23012 GP23013 GP23014 GP23015 GP23016 GP23017 GP23018 GP23019 GP23020 GP23021 GP23022 GP23023 GP23025 GP23026 GP23027 GP23028 GP23029 GP23045 GP23047 GP23048 GP23049 GP23050 GP23051 GP23052 GP23053 GP23054 GP23055 GP23057 GP23058 GP23059 GP23061 GP23062 GP23063 GP23064 GP23066 GP23067 GP23068 GP23070 GP23072 GP23074 GP23075 GP23078 GP23079 GP23080 GP23081 GP24140 GP24141 GP24143 GP24144 GP24145 GP24146 GP24148 GP24149 GP24150 GP24151 GP24152 GP24154 GP24155 GP24156 GP24157 GP24158 GP24159 GP24160 GP24161 GP24162 GP24163 GP24165 GP24167 GP24178 GP24186 GP24190 GP24191 GP24196 GP24198 GP24201 GP24211 GP24212 GP24214 GP24216 GP24217 GP24219 GP24224 GP24227 GP24239 GP24240 GP24241 GP24242 GP24243 GP24245 GP24246 GP24247 GP24248 GP24249 GP24251 GP24252 GP24254 GP24255 GP24417 GP24498 GP24500 GP24501 GP24502 GP24507 GP24510 GP24512 GP24513 GP24515 GP24517 GP24519 GP24632 GP24633 GP24634 GP24635 GP24637 GP24638 GP24639 GP24640 GP24641 GP24642 GP24643 GP24644 GP24646 GP24649 GP24652 GP24653 GP24656 GP24657 GP24935 GP24936 GP24937 GP24938 GP24940 GP25193 GP25520 GP25626 GP25628 GP25629 GP25630 GP25631 GP25632 GP25633 GP25635 GP25636 GP25637 GP25638 GP25639 GP25640 GP25643 GP25644 GP25645 GP25661 GP26132 GP26156 GP26159 GP26163 GP26168 GP26559 GP26569 GP26891 GP26894 GP27304 GP72174 GP73165 GP81318 GP86863 GP88745 GP88813 GP89151 GP89160 GQ54806 GQ55061 GQ57085 GQ57088 GQ57091 GQ57092 GQ57108 GQ57121 GQ57408 GQ57686 GQ58195 GQ58796 GQ59111 GQ59354 GQ59357 GQ59475 GQ59536 GQ59583 GQ59584 GQ59586 GQ59589 GQ59625 GQ66662 GQ66662 GQ67868 GQ67868 GS51109 GS51110 GS51454 GS52142 GS52159 GS57409 GS57411 GS57429 GS57497 GS57705 GS66502 GS66559 GS71508 GS71840 GS71862 GS71929 GS73525 GS74643 GS76563 GS77360 GS78770 GS78771 GS78967 GS79507 GS80522 GS80557 GS80568 GS86915 GW62494 GW62880 GW62885 GW63035 GW63046 GW63107 GW65244 GW65246 GW65304 GW65312 GW65332 GW65493 GW65501 GW65510 GW65534 GW65550 GW65563 GW65582 GW65585 GW65593 GW65809 GW65810 GW65815 GW67665 GW67772 GW67775 GW68028 GW68033 GW68048 GW68049 GW68072 GW68076 GW68078 GW68129 GW68351 GW68579 GW68602 GW68606 GW68607 GW68619 GW68620 GW68623 GW68630 GW68793 GW68830 GW68834 GW68873 GW68875 GW68894 GW68899 GW68901 GW68903 GW68912 GW68914 GW68982 GW68989 GW68993 GW68995 GW68999 GW69010 GW69013 GW69014 GW69015 GW69018 GW69021 GW69022 GW69026 GW69032 GW69038 GW69041 GW69046 GW69048 GW77488 GW77488 GW77489 GW77489 GW77492 GW77492 GW77497 GW77497 GW77501 GW77503 GW77503 GW77514 GW77514 GW78471 GW78474 GW78475 GW78496 GW8796 GX94357 GX94359 GX94376 GX94393 GX94434 GX94437 GX97376 GX98734 GX98741 GX98796 GX98810 GX98829 GX98830 GX99029 GX99073 GX99074 GX99076 GX99082 GX99086 GX99092 GX99099 GX99104 GX99108 GX99121 GX99162 GX99167 GX99181 GX99401 GX99414 GX99436 GX99437 GX99439 GX99455 GX99460 GX99464 GX99466 GY00722 GY00723 GY00724 GY00725 GY00729 GY00932 GY00933 GY00934 GY00935 GY00936 GY00937 GY01144 GY01145 GY01146 GY01147 GY01148 GY01149 GY01150 GY01151 GY01152 GY01153 GY01154 GY01166 GY01241 GY01242 GY01243 GY01244 GY01245 GY01246 GY01247 GY01248 GY01249 GY01250 GY01251 GY01252 GY01253 GY01254 GY01255 GY01316 GY01317 GY01319 GY01322 GY01323 GY01324 GY01326 GY01327 GY01328 GY01329 GY01330 GY01331 GY01332 GY01364 GY01369 GY01377 GY01393 GY01395 GY01396 GY01397 GY01400 GY01401 GY01402 GY01403 GY01405 GY01406 GY01407 GY01408 GY01409 GY01415 GY01419 GY01421 GY01422 GY01424 GY01427 GY01428 GY01429 GY01430 GY01431 GY01432 GY01433 GY01434 GY01437 GY01438 GY01439 GY01440 GY01441 GY01443 GY01445 GY01446 GY01449 GY01450 GY01452 GY01453 GY01456 GY01457 GY01458 GY01459 GY01460 GY01461 GY01462 GY06472 GY06473 GY06474 GY06475 GY06476 GY07496 GY07496 GY07501 GY07501 GY09922 GY09925 GY09927 GY09928 GY09931 GY09932 GY09934 GY09936 GZ02347 GZ02350 GZ02828 GZ02834 GZ02841 GZ03297 GZ03302 GZ03308 GZ03309 GZ03310 GZ03311 GZ03317 GZ03318 GZ03330 GZ03338 GZ03350 GZ03354 GZ03374 GZ03375 GZ03454 GZ03455 GZ03475 GZ03733 GZ03746 GZ03768 GZ03769 GZ03805 GZ03810 GZ03815 GZ03859 GZ03924 GZ03929 GZ03930 GZ03934 GZ03945 GZ03952 GZ03980 GZ03982 GZ04254 GZ04322 GZ04327 GZ04328 GZ04338 GZ04340 GZ04353 GZ04360 GZ04365 GZ04370 GZ04422 GZ04423 GZ04424 GZ04431 GZ04434 GZ04449 GZ04451 GZ04457 GZ04460 GZ04462 GZ04465 GZ04480 GZ04528 GZ04530 GZ17984 GZ18020 Y96205 Y96397 Y96398 Y96400 Y96401 Y96403 Y96404 Y96405 Y96406 Y96408 Y96423 Y96425 Y96426 Y96427 Y96428 Y96429 Y96430 Y96431 Y96432 Y96433 Y96434 Y96435 Y96436 Y96437 Y96438 Y96466 Y96468 Y96469 Y96472 Y96475 Y96476 Y96478 Y96479 Y96829 Y96831 Y96832 Y96833 Y96834 Y99027 Y99035 Y99036 Y99038 Y99058 Y99107 Y99108 Y99109 Y99110 Y99111 Y99112 Y99114 Y99115 Y99116 Y99117 Y99118 Y99119 Y99120 Y99123 Y99124 Y99125 Y99126 Y99127 Y99128 Y99129 Y99130 Y99131 Y99132 Y99133 Y99134 Y99135 Y99136 Y99138 Y99139 Y99872 Y99874 Y99875 Y99876 Y99877 Y99878 Y99880 Y99881 GP22662 GS32728 GC06857 GC06858 GC06860 GC06866 GC07169 GC07170 GC07171 GC07172 GC07173 GC07175 GC07176 GC07177 GC07178 GC07179 GC07180 GC07181 GC07183 GC08153 GC08155 GN79574 GN79575 GN79576 GN79577 GN79578 GN79579 GN79580 GN79582 GN79583 GN79584 GN79585 GN79586 GN79587 GN79588 GN79589 GN79590 GN79591 GN79592 GN79593 GN79595 GN79596 GN79597 GN79598 GN79599 GN79600 GN79601 GN79616 GN79617 GN79618 GN79620 GN79622 GN79623 GN79624 GN82286 GN82287 GN82288 GN82289 GN82290 GN82291 GN82293 GN82294 GN82295 GN82296 GN82461 GN82464 GN82465 GN82466 GN82467 GN82468 GN82470 GN82471 GN82474 GN82475 GN82477 GN82478 GN82479 GN82480 GN82482 GN82483 GN82484 GN82485 GN82486 GN82487 GN82488 GN82490 GN82491 GN82492 GN82497 GN82498 GN82499 GN82500 GN82549 GN82551 GN82552 GN82553 GN82554 GN82556 GN82557 GN82558 GN82559 GN82618 GN82623 GN82625 GN83194 GN83195 GN83196 GN83197 GN83198 GN83199 GN83200 GN83201 GN83202 GN83203 GN83204 GN83206 GN83208 GN83221 GN83222 GN83225 GN83227 GN83228 GN83230 GN83234 GN83287 GN83288 GN83289 GN83290 GN83291 GN83294 GN83296 GN83297 GN83299 GN83300 GN83306 GN83312 GN83313 GN83314 GN83394 GN83397 GN83398 GN83399 GN83400 GN83401 GN83402 GN83403 GN83404 GN83405 GN83406 GN83573 GN83575 GN83576 GN83577 GN83584 GN83585 GN83587 GN83588 GN83591 GN83592 GN83594 GN83595 GN83599 GN83600 GN83601 GN83876 GN83879 GN83882 GN83884 GN83886 GN84155 GN84159 GN84160 GN84161 GN84162 GN84163 GN84164 GN84166 GN84174 GN84325 GN84377 GN84378 GN84381 GN84389 GN84392 GN84393 GN84398 GN84399 GN84403 GN84405 GN84406 GN84407 GN84491 GN84492 GN84500 GN85172 GN85327 GN85328 GN85331 GN85332 GN85333 GN85339 GN85344 GN85345 GN85346 GN85348 GN85350 GN85351 GN85353 GN85548 GN85673 GN85674 GN85675 GN85676 GN85677 GN85678 GN85679 GN85680 GN85681 GN85682 GN85683 GN85684 GN86001 GN86002 GN86004 GN86005 GN86006 GN86013 GN86040 GN86063 GN86076 GN86078 GN86081 GN86082 GN86083 GN86084 GN86085 GN86086 GN86087 GN86090 GN86103 GN86126 GN86127 GN86138 GN86140 GN86143 GN86152 GN86160 GN86164 GN86165 GN86168 GN86169 GN86172 GN86174 GN86177 GN86178 GN86181 GN86182 GN86183 GN86186 GN86187 GN86189 GN86190 GN86192 GN86194 GN86203 GN86204 GN86207 GN86210 GN86211 GN86245 GN87007 GN87020 GN87021 GN87022 GN87023 GN87024 GN87025 GN87026 GN87027 GN87028 GN87030 GN87031 GN87032 GN87033 GN87034 GN87364 GN90982 GN90985 GN90991 GN90992 GN90993 GN90994 GN90998 GN92376 GN92378 GN92386 GN92388 GN92910 GN92912 GN92999 GN94538 GN94544 GN94546 GN94547 GN94548 GN94549 GN94550 GN94551 GN94552 GN94553 GN94554 GN94556 GN94557 GN94559 GN94560 GN94561 GN95077 GN95078 GN95080 GN95081 GN95083 GN95084 GN95085 GN95086 GN95088 GN95090 GN95525 GN95526 GN95527 GN95528 GN95529 GN95530 GN95532 GN95534 GN95535 GN97646 GN97653 GN97655 GN97656 GN97668 GN97669 GN97676 GN98868 GN99628 GN99632 GN99723 GN99724 GN99734 GN99738 GN99741 GN99747 GN99852 GN99855 GN99858 GN99879 GN99880 GN99882 GN99889 GN99897 GN99899 GN99900 GN99901 GN99902 GN99903 GN99904 GN99906 GN99907 GN99909 GN99910 GN99911 GN99912 GN99913 GN99915 GN99916 GN99918 GN99919 GN99920 GN99921 GN99922 GN99923 GN99924 GN99926 GN99927 GN99930 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GX95121 GX95122 GX95123 GX95124 GX95125 GX95131 GX95133 GX95135 GX95136 GX95137 GX95139 GX95140 GX95141 GX95219 GX95222 GX95223 GX95228 GX95234 GX95236 GX95237 GX95241 GX95242 GX95243 GX95244 GX95342 GX95350 GX97382 GX97383 GX97387 GX97392 GX97395 GX97398 GX97421 GX98804 GX99124 GX99126 GX99127 GX99128 GX99129 GX99131 GX99133 GX99134 GX99135 GX99176 GX99177 GX99182 GX99183 GX99184 GX99186 GX99188 GX99192 GX99193 GX99195 GX99197 GX99199 GX99200 GX99201 GX99202 GX99205 GX99206 GX99207 GX99209 GX99211 GX99220 GX99222 GX99223 GX99233 GX99234 GX99236 GX99237 GX99238 GX99241 GX99243 GX99244 GX99245 GX99246 GX99623 GX99625 GX99630 GX99635 GX99636 GX99639 GX99815 GY07496 GY07498 GY07498 GY07499 GY07501 GY07502 GY07502 GY07504 GY07504 GY07505 GY07505 GY08264 GY08265 GY08266 GY08267 GY08268 GY08269 GY08270 GY08271 GY08272 GY08273 GY08274 GY08275 GY09923 GY09924 GY09926 GY09930 GY09935 GZ02323 GZ02325 GZ02326 GZ02328 GZ02346 GZ02348 GZ02349 GZ03246 GZ03247 GZ03248 GZ03249 GZ03250 GZ03252 GZ03253 GZ03254 GZ03255 GZ03256 GZ03298 GZ03299 GZ03300 GZ03301 GZ03303 GZ03304 GZ03306 GZ03307 GZ03312 GZ03313 GZ03314 GZ03315 GZ03316 GZ03319 GZ03320 GZ03328 GZ03329 GZ03331 GZ03332 GZ03333 GZ03334 GZ03335 GZ03336 GZ03337 GZ03339 GZ03340 GZ03341 GZ03342 GZ03343 GZ03344 GZ03345 GZ03346 GZ03347 GZ03348 GZ03349 GZ03351 GZ03353 GZ03355 GZ03356 GZ03358 GZ03359 GZ03360 GZ03361 GZ03362 GZ03363 GZ03364 GZ03365 GZ03366 GZ03367 GZ03368 GZ03369 GZ03371 GZ03372 GZ03373 GZ03376 GZ03377 GZ03378 GZ03379 GZ03484 GZ03485 GZ03486 GZ03488 GZ03489 GZ03491 GZ03493 GZ03494 GZ03495 GZ03498 GZ03499 GZ03501 GZ03522 GZ03653 GZ03728 GZ03729 GZ03730 GZ03731 GZ03732 GZ03742 GZ03743 GZ03745 GZ03748 GZ03749 GZ03750 GZ03751 GZ03752 GZ03753 GZ03755 GZ03756 GZ03757 GZ03759 GZ03860 GZ03861 GZ03862 GZ03863 GZ03865 GZ03956 GZ04019 GZ04020 GZ04021 GZ04022 GZ04023 GZ04026 GZ04027 GZ04028 GZ04029 GZ04031 GZ04032 GZ04034 GZ04035 GZ04036 GZ04037 GZ04038 GZ04039 GZ04040 GZ04041 GZ04043 GZ04044 GZ04045 GZ04188 GZ04189 GZ04190 GZ04191 GZ04192 GZ04193 GZ04194 GZ04195 GZ04196 GZ04199 GZ04202 GZ04203 GZ04204 GZ04206 GZ04207 GZ04208 GZ04210 GZ04211 GZ04215 GZ04216 GZ04246 GZ04247 GZ04249 GZ04252 GZ04297 GZ04316 GZ04317 GZ04318 GZ04320 GZ04321 GZ04324 GZ04325 GZ04326 GZ04329 GZ04330 GZ04334 GZ04335 GZ04343 GZ04344 GZ04345 GZ04346 GZ04347 GZ04349 GZ04350 GZ04354 GZ04355 GZ04356 GZ04358 GZ04443 GZ04446 GZ04448 GZ04455 GZ04458 GZ04459 GZ04461 GZ04463 GZ04464 GZ04466 GZ04467 GZ04468 GZ04472 GZ04473 GZ04474 GZ04475 GZ04476 GZ04477 GZ04478 GZ04479 GZ04481 GZ04490 GZ04498 GZ04499 GZ04502 GZ04503 GZ04504 GZ04505 GZ04506 GZ04507 GZ04508 GZ04509 GZ04510 GZ04512 GZ04532 GZ04569 GZ04573 GZ04576 GZ04577 GZ04578 GZ04579 GZ04580 GZ04581 GZ04582 GZ04584 GZ04585 GZ04586 GZ04587 GZ04588 GZ04589 GZ04598 GZ04599 GZ04601 GZ04602 GZ04604 GZ04605 GZ04606 GZ04607 GZ04608 GZ04609 GZ04610 GZ04615 GZ04616 GZ04617 GZ04618 GZ04620 GZ04624 GZ04625 GZ14497 GZ14504 GZ14505 GZ14507 GZ14511 GZ14513 GZ14515 GZ14516 GZ14517 GZ14518 GZ14519 GZ14520 GZ14523 GZ14532 GZ14533 GZ14584 GZ14585 GZ14587 GZ14588 GZ14589 GZ14590 GZ14591 GZ14600 GZ14601 GZ14602 GZ14603 GZ14604 GZ16508 GZ16509 GZ16509 GZ16510 GZ16510 GZ17985 GZ17986 GZ17987 GZ17988 GZ17989 GZ18016 GZ18017 GZ18018 GZ18019 GZ18021 GZ18022 GZ18023 GZ18024 GZ18025 GZ18026 GZ21057 GZ21065 GZ21070 GZ21071 GZ21072 GZ21073 GZ21074 GZ21077 GZ21080 GZ21081 GZ21083 GZ21086 GZ21087 GZ21088 GZ21089 GZ21090 GZ21092 GZ21093 GZ21095 GZ21096 GZ21098 GZ21101 GZ21102 GZ21103 GZ21104 GZ21105 GZ21108 Y96720 Class III Blood products, which exceeded time limits taken out of storage for labeling, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Platelets Pheresis Leukocytes Reduced, Codes: LPAA, LPAB, LPA, LPAC GS50898 GS50917 GS50919 GS66370 GS66372 GS66373 GS68610 GS68614 GS68616 GS68617 GS68620 GS68621 GS68622 GS68627 GS68922 GS69379 GS69381 GS69463 GS69464 GS70344 GS70345 GS70346 GS70406 GS70407 GS70408 GS70410 GS70411 GS70412 GS70417 GS72560 GS72561 GS72566 GS72567 GS72913 GS72914 GS72915 GS72916 GS72918 GS72922 GS72923 GS73455 GS75510 GS75510 GS75512 GS75512 GS75530 GS75537 GS77276 GS77282 GS77287 GS77290 GS77291 GS77294 GS77296 GS78395 GS78541 GS78543 GS80419 GS84016 GS66356 GS66358 GS66362 GS68611 GS68612 GS68613 GS68615 GS68618 GS68619 GS68623 GS68625 GS68626 GS68917 GS68918 GS68919 GS68920 GS70347 GS70394 GS70402 GS70403 GS70404 GS70405 GS70409 GS70413 GS70414 GS70415 GS70416 GS72559 GS72562 GS72563 GS72565 GS72917 GS72920 GS72921 GS72924 GS72933 GS72936 GS72938 GS73396 GS73452 GS73456 GS74918 GS74921 GS74922 GS75523 GS75526 GS75531 GS75532 GS75533 GS75534 GS77283 GS77295 GS77297 GS78394 GS78396 GS78404 GS78406 GS80417 GS66356 GS66358 GS66362 GS68612 GS68613 GS68615 GS68618 GS68619 GS68623 GS68625 GS68626 GS68917 GS68918 GS68919 GS68920 GS70347 GS70394 GS70402 GS70403 GS70404 GS70405 GS70409 GS70413 GS70414 GS70415 GS70416 GS72559 GS72562 GS72563 GS72565 GS72917 GS72920 GS72921 GS72924 GS72933 GS72936 GS72938 GS73396 GS73397 GS73452 GS73456 GS74918 GS74921 GS74922 GS75523 GS75526 GS75526 GS75531 GS75533 GS75534 GS77283 GS77295 GS77297 GS78394 GS78396 GS78404 GS78406 GS78555 GS80417 GS66356 GS68613 GS70414 Class III Blood products, which exceeded time limits taken out of storage for labeling, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Platelets Pheresis Leukocytes Reduced Irradiated, Code: ILPAA GS73397 GS75526 Class III Blood products, which exceeded time limits taken out of storage for labeling, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Cryoprecipitated AHF, Pooled, Code: PCRY G09140 G09139 G09138 G07119 G07120 G07121 G07122 G07123 G07124 G07125 G07126 G07127 G07130 G07131 G07132 G07145 G07146 G07147 G07148 G07149 G07151 G07152 G07153 G07154 G07155 G07157 G07158 G07169 G07170 G07171 G07172 G07173 G07174 G07175 G07176 G07177 G07178 G07181 G07182 G07183 G07184 G08324 G08325 G08326 G08327 G08329 G08330 G08382 G08409 G08410 G08411 G08426 G08427 G08971 G08972 G08977 G08979 G09087 G09088 G09089 G09090 G09091 Class III Blood products, which exceeded time limits taken out of storage for labeling, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Cryoprecipitated Reduced, Code: CRY GN93464 GN96667 GN96700 GN96737 GN97580 GN97837 GN99456 GN99461 GN99464 GP00343 GP00355 GP00367 GP02213 GP02215 GP03171 GP03870 GP06177 GP06178 GP07347 GP07348 GP07925 GP07955 GP07982 GP09298 GP10343 GP10344 GP10660 GP11285 GP11497 GP12429 GP16144 GP16161 GP16176 GP16180 GP16188 GP16189 GP16194 GP16402 GP16633 GP16636 GP16659 GP16664 GP16671 GP16673 GP16679 GP16687 GP16689 GP16701 GP16712 GP16714 GP16726 GP16786 GP16799 GP16806 GP17382 GP17405 GP18518 GP18519 GP18522 GP18547 GP18549 GP20914 GP20922 GP20937 GP22386 GP22396 GP22686 GP22706 GS85943 GS85947 GS85969 GS87971 GS87972 GS87973 GS87977 GS87979 GS95309 GS95324 GX99180 GZ00077 GZ00111 GZ00710 GZ00975 GZ00982 GZ01977 GZ01985 GZ01988 GZ01990 GZ01996 GZ01997 GZ02009 GZ02013 GZ02026 GZ02028 GZ02040 GZ02268 GZ02273 GZ02302 GZ02315 GZ02317 GZ02321 GZ02323 GZ02330 GZ02331 GZ02341 GZ02351 GZ02574 GZ02578 GZ02586 GZ02591 GZ02602 GZ02612 GZ02928 GZ02929 GZ02937 GZ02942 GZ03004 GZ03005 GZ03011 GZ03012 GZ03018 GZ03030 GZ03053 GZ03055 GZ03057 GZ03069 GZ03075 GZ03299 GZ03301 GZ03303 GZ03304 GS62285 GS67560 Class III Blood products, which exceeded time limits taken out of storage for labeling, were distributed. Blood Bank of San Bernardino and Riverside Counties
Biologics Red Blood Cells Leukocytes Reduced 011KJ13127 (2 units), 011KJ13201 (2 units) Class II Blood products, for which the quality control testing was not performed, were distributed. American Red Cross Blood Services
Biologics Red Blood Cells Leukocytes Reduced 07FQ48267 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced W051408112578 Class II Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed. Community Blood Bank, Inc.
Biologics Source Plasma 09EINA0084, 09EINA0119, 09EINA0123, 09EINA0134, 09EINA0141, 09EINA0167, 09EINA0189, 09EINA0196, 09EINA0216, 09EINA0222, 09EINA0264, 09EINA0259, 09EINA0261, 09EINA0301, 09EINA0272, 09EINA0328, 09EINA0330, 09EINA0379, 09EINA0380, 09EINA0422, 09EINA0414, 09EINA0452, 09EINA0502, 09EINA0500, 09EINA0491, 09EINA0538, 09EINA0536, 09EINA0576, 09EINA0580, 09EINA0575, 09EINA0585, 09EINA0598, 09EINA0615, 09EINA0629, 09EINA0638, 09EINA0654, 09EINA0686, 09EINA0683, 09EINA0704, 09EINA0696, 09EINA0700, 09EINA0741, 09EINA0743, 09EINA0766, 09EINA0781, 09EINA0791, 09EINA0780, 09EINA0805, 09EINA0823, 09EINA0847, 09EINA0850, 09EINA0841, 09EINA0881, 09EINA0886, 09EINA0904, 09EINA0903, 09EINA0957, 09EINA0992, 09EINA0997, 09EINA0988, 09EINA0966, 09EINA1024, 09EINA0220, 09EINA0559, 09EINA1056, 09EINA0972, 09EINA1071, 09EINA1075, 09EINA1115, 09EINA1112, 09EINA1162, 09EINA1174, 09EINA1192, 09EINA1187, 09EINA1200, 09EINA1209, 09EINA1232, 09EINA1222, 09EINA1238, 09EINA1248, 09EINA1250, 09EINA1240, 09EINA1272, 09EINA1273, 09EINA1283, 09EINA1325, 09EINA1330, 09EINA1343, 09EINA1354, 09EINA1366, 09EINA1406, 09EINA1419, 09EINA1417, 09EINA1449, 09EINA1454, 09EINA1458, 09EINA1457, 09EINA1492, 09EINA1506, 09EINA1521, 09EINA1519, 09EINA1523, 09EINA1532, 09EINA1565, 09EINA1585, 09EINA1598, 09EINA1615, 09EINA1621, 09EINA1630, 09EINA1656, 09EINA1667, 09EINA1649, 09EINA1711, 09EINA1721, 09EINA1719, 09EINA1723, 09EINA1753, 09EINA1742, 09EINA1751, 09EINA1788, 09EINA1802, 09EINA1820, 09EINA1816, 09EINA1846, 09EINA1884, 09EINA1895, 09EINA1910, 09EINA1916, 09EINA1897, 09EINA1926, 09EINA1927, 09EINA1928, 09EINA1988, 09EINA1993, 09EINA1984, 09EINA1987, 09EINA2021, 09EINA2037, 09EINA2044, 09EINA2056, 09EINA2055, 09EINA2059, 09EINA2098, 09EINA2168, 09EINA2179, 09EINA2137, 09EINA2213, 09EINA2209, 09EINA2233, 09EINA2230, 09EINA2262, 09EINA2292, 09EINA2293, 09EINA2274, 09EINA2285, 09EINA2283, 09EINA2297, 09EINA2322, 09EINA2327, 09EINA2325, 09EINA2313, 09EINA2338, 09EINA2360, 09EINA2376, 09EINA2379, 09EINA2427, 09EINA2414, 09EINA2451, 09EINA2471, 09EINA2503, 09EINA2488, 09EINA2520, 09EINA2519, 09EINA2532, 09EINA2539, 09EINA2573, 09EINA2567, 09EINA2612, 09EINA2641, 09EINA2636, 09EINA2670, 09EINA2715, 09EINA2678, 09EINA2724, 09EINA2725, 09EINA2749, 09EINA2740, 09EINA2735, 09EINA2072, 09EINA2270, 09EINA2389, 09EINA2447, 09EINA2681, 09EINA2652, 09EINA2651, 09EINA2736, 09EINA2726, 09EINA2742, 09EINA2799, 09EINA2804, 09EINA2806, 09EINA2811, 09EINA2839, 09EINA2827, 09EINA2855, 09EINA2892, 09EINA2893, 09EINA2899, 09EINA2907, 09EINA2965, 09EINA2975, 09EINA3024, 09EINA3023, 09EINA3013, 09EINA3034, 09EINA3040, 09EINA3049, 09EINA3042, 09EINA3048, 09EINA3046, 09EINA3070, 09EINA3091, 09EINA3137, 09EINA3141, 09EINA3159, 09EINA3158, 09EINA3165, 09EINA3172, 09EINA3181, 09EINA3199, 09EINA3212, 09EINA3230, 09EINA3244, 09EINA3259, 09EINA3270, 09EINA3316, 09EINA3319, 09EINA3339, 09EINA3334, 09EINA3350, 09EINA3345, 09EINA3343, 09EINA3376, 09EINA3381, 09EINA3382, 09EINA3421, 09EINA3413, 09EINA3429, 09EINA3423, 09EINA3447, 09EINA3438, 09EINA3450, 09EINA3460, 09EINA3472, 09EINA3499, 09EINA3531, 09EINA3543, 09EINA3561, 09EINA3558, 09EINA3583, 09EINA3603, 09EINA3604, 09EINA3602, 09EINA3637, 09EINA3635, 09EINA3646, 09EINA3675, 09EINA3676, 09EINA3734, 09EINA3721, 09EINA3742, 09EINA3749, 09EINA3765, 09EINA3762, 09EINA3774, 09EINA3783, 09EINA3817, 09EINA3826, 09EINA3848, 09EINA2679, 09EINA3847, 09EINA3844, 09EINA3864, 09EINA3573, 09EINA3835, 09EINA3880, 09EINA3877, 09EINA3889, 09EINA3887, 09EINA3912, 09EINA3906, 09EINA3915, 09EINA3948, 09EINA3944, 09EINA3939, 09EINA3951, 09EINA2472, 09EINA3872, 09EINA3964, 09EINA3680, 09EINA3979, 09EINA3990, 09EINA4018, 09EINA4048, 09EINA4080, 09EINA4076, 09EINA4075, 09EINA4109, 09EINA4093, 09EINA4164, 09EINA4141, 09EINA4136, 09EINA4169, 09EINA4182, 09EINA4194, 09EINA4185, 09EINA4203, 09EINA4219, 09EINA4224, 09EINA4212, 09EINA4215, 09EINA4239, 09EINA4227, 09EINA4250, 09EINA4255, 09EINA4268, 09EINA4291, 09EINA4288, 09EINA4328, 09EINA4324, 09EINA4316, 09EINA4362, 09EINA4359, 09EINA4383, 09EINA4370, 09EINA4373, 09EINA4389, 09EINA4432, 09EINA4420, 09EINA4443, 09EINA4442, 09EINA4447, 09EINA4463, 09EINA4486, 09EINA4480, 09EINA4488, 09EINA4528, 09EINA4563, 09EINA4570, 09EINA4568, 09EINA4566, 09EINA4605, 09EINA4633, 09EINA4629, 09EINA4631, 09EINA4648, 09EINA4649, 09EINA4641, 09EINA4705, 09EINA4717, 09EINA4715, 09EINA4731, 09EINA4738, 09EINA4732, 09EINA4743, 09EINA4766, 09EINA4749, 09EINA4784, 09EINA4813, 09EINA4811, 09EINA4849, 09EINA4848, 09EINA4884, 09EINA4877, 09EINA4913, 09EINA3622, 09EINA4099, 09EINA4143, 09EINA4236, 09EINA4692, 09EINA4712, 09EINA4896, 09EINA4875, 09EINA4894, 09EINA4942, 09EINA4963, 09EINA4975, 09EINA4977, 09EINA4993, 09EINA5010, 09EINA5055, 09EINA5048, 09EINA5069, 09EINA5070, 09EINA5092, 09EINA5100, 09EINA5113, 09EINA5181, 09EINA5171, 09EINA5184, 09EINA5200, 09EINA5211, 09EINA5232, 09EINA5263, 09EINA5289, 09EINA5293, 09EINA5282, 09EINA5323, 09EINA5317, 09EINA5344, 09EINA5351, 09EINA5360, 09EINA5375, 09EINA5385, 09EINA5395, 09EINA5423, 09EINA5427, 09EINA5430, 09EINA5444, 09EINA5455, 09EINA5456, 09EINA5477, 09EINA5463, 09EINA5466, 09EINA5492, 09EINA5505, 09EINA5498, 09EINA5528, 09EINA5518, 09EINA5525, 09EINA5529, 09EINA5556, 09EINA5550, 09EINA5591, 09EINA5612, 09EINA5614, 09EINA5650, 09EINA5666, 09EINA5681, 09EINA5678, 09EINA5695, 09EINA5693, 09EINA5707, 09EINA5717, 09EINA5732, 09EINA5760, 09EINA5795, 09EINA5793, 09EINA5798, 09EINA5828, 09EINA5844, 09EINA5839, 09EINA5861, 09EINA5881, 09EINA5909, 09EINA5925, 09EINA5935, 09EINA5988, 09EINA5993, 09EINA6001, 09EINA6019, 09EINA6016, 09EINA6023, 09EINA6053, 09EINA6089, 09EINA6097, 09EINA6092, 09EINA6115, 09EINA6112, 09EINA6110, 09EINA6138, 09EINA6139, 09EINA6146, 09EINA6175, 09EINA6192, 09EINA6201, 09EINA6208, 09EINA6230, 09EINA6216, 09EINA6270, 09EINA6275, 09EINA6267, 09EINA6284, 09EINA6318, 09EINA6316, 09EINA6304, 09EINA6295, 09EINA3474, 09EINA4669, 09EINA6204, 09EINA6294, 09EINA6301, 09EINA6299, 09EINA6337, 09EINA6343, 09EINA6349, 09EINA6358, 09EINA6377, 09EINA6374, 09EINA6394, 09EINA6401, 09EINA6415, 09EINA6428, 09EINA6436, 09EINA6450, 09EINA6474, 09EINA6506, 09EINA6527, 09EINA6546, 09EINA6539, 09EINA6555, 09EINA6571, 09EINA6595, 09EINA6626, 09EINA6635, 09EINA6633, 09EINA6648, 09EINA6659, 09EINA6658, 09EINA6667, 09EINA6701, 09EINA6713, 09EINA6721, 09EINA6724, 09EINA6738, 09EINA6737, 09EINA6772, 09EINA6779, 09EINA6767, 09EINA6819, 09EINA6839, 09EINA6831, 09EINA6827, 09EINA6853, 09EINA6113, 09EINA6422, 09EINA6569, 09EINA6676, 09EINA6522, 09EINA6673, 09EINA6861, 09EINA6834, 09EINA6863, 09EINA6871, 09EINA6882, 09EINA6917, 09EINA6932, 09EINA6934, 09EINA6941, 09EINA6944, 09EINA6938, 09EINA6962, 09EINA6955, 09EINA6966, 09EINA6986, 09EINA6985, 09EINA6983, 09EINA6993, 09EINA7035, 09EINA7033, 09EINA7032, 09EINA7056, 09EINA7055, 09EINA7060, 09EINA7066, 09EINA7084, 09EINA7105, 09EINA7117, 09EINA7129, 09EINA7130, 09EINA7123, 09EINA7142, 09EINA7145, 09EINA7179, 09EINA7169, 09EINA4624, 09EINA6832, 09EINA7180, 09EINA7122, 09EINA7139, 09EINA7191, 09EINA7198, 09EINF4212, 09EINF4235, 09EINF4265, 09EINF4246, 09EINF4271, 09EINF4267, 09EINF4301, 09EINF4293, 09EINF4328, 09EINF4357, 09EINF4375, 09EINF4384, 09EINF4450, 09EINF4476, 09EINF4505, 09EINF4520, 09EINF4537, 09EINF4573, 09EINF4569, 09EINF4588, 09EINF4584, 09EINF4582, 09EINF4611, 09EINF4619, 09EINF4663, 09EINF4672, 09EINF4686, 09EINF4715, 09EINF4710, 09EINF4777, 09EINF4802, 09EINF4829, 09EINF4838, 09EINF4837, 09EINF4869, 09EINF4873, 09EINF4927, 09EINF4950, 09EINF4958, 09EINF4964, 09EINF4382, 09EINF4722, 09EINF4984, 09EINF5000, 09EINF5070, 09EINF5090, 09EINF5103, 09EINF5125, 09EINF5197, 09EINF5196, 09EINF5236, 09EINF5219, 09EINF5254, 09EINF5262, 09EINF5297, 09EINF5310, 09EINF5318, 09EINF5331, 09EINF5356, 09EINF5378, 09EINF5379, 09EINF5395, 09EINF5435, 09EINF5445, 09EINF5472, 09EINF5485, 09EINF5517, 09EINF5514, 09EINF5519, 09EINF5534, 09EINF5543, 09EINF5565, 09EINF5563, 09EINF5581, 09EINF5572, 09EINF5608, 09EINF5607, 09EINF5621, 09EINF5660, 09EINF5663, 09EINF5690, 09EINF5749, 09EINF5766, 09EINF5789, 09EINF5864, 09EINF5862, 09EINF5854, 09EINF5855, 09EINF5882, 09EINF5904, 09EINF5908, 09EINF5922, 09EINF5936, 09EINF3522, 09EINF0346, 09EINF3614, 09EINF4640, 09EINF5872, 09EINF5968, 09EINF6029, 09EINF6050, 09EINF6090, 09EINF6086, 09EINF6106, 09EINF6094, 09EINF6174, 09EINF6203, 09EINF6202, 09EINF6240, 09EINF6260, 09EINF6266, 09EINF6276, 09EINF6310, 09EINF6350, 09EINF6363, 09EINF6388, 09EINF6433, 09EINF6445, 09EINF6446, 09EINF6451, 09EINF6448, 09EINF6487, 09EINF6504, 09EINF6526, 09EINF6541, 09EINF6600, 09EINF6613, 09EIND6664, 09EIND6653, 09EIND6661, 09EIND6675, 09EIND6682, 09EIND6726, 09EIND6741, 09EIND6786, 09EIND6869, 09EIND6867, 09EIND6889, 09EIND6919, 09EIND6916, 09EIND6918, 09EIND6940, 09EIND6957, 09EIND6975, 09EIND6990, 09EIND6984, 09EIND7030, 09EIND7048, 09EIND7052, 09EIND7074, 09EIND7106, 09EIND7105, 09EIND7117, 09EIND7118, 09EIND7132, 09EIND7191, 09EIND7202, 09EIND7221, 09EIND7220, 09EIND7231, 09EIND7276, 09EIND7268, 09EIND7271, 09EIND7284, 09EIND7299, 09EIND7308, 09EINE1335, 09EINE0929, 09EINE0955, 09EINE1350, 09EINE1349, 09EINE1378, 09EINE1379, 09EINE1404, 09EINE1422, 09EINE1465, 09EINE1458, 09EINE1470, 09EINE1487, 09EINE1486, 09EINE1500, 09EINE1505, 09EINE1527, 09EINE1537, 09EINE1531, 09EINE1542, 09EINE1559, 09EINE1562, 09EINE1566, 09EINE1594, 09EINE1596, 09EINE1619, 09EINE1660, 09EINE1657, 09EINE1652, 09EINE1663, 09EINE1671, 09EINE1687, 09EINE1689, 09EINE1703, 09EINE1727, 09EINE1743, 09EINE1752, 09EINE1777, 09EINE1783, 09EINE4224, 09EINE4222, 09EINE4238, 09EINE4241, 09EINE4261, 09EINE4304, 09EINE4290, 09EINE4296, 09EINE4310, 09EINE4315, 09EINE4317, 09EINE4338, 09EINE4360, 09EINE4365, 09EINE4387, 09EINE4420, 09EINE4442, 09EINE4443, 09EINE4454, 09EINE4453, 09EINE4457, 09EINE4459, 09EINE4463, 09EINE4461, 09EINE4478, 09EINE4493, 09EINE4487, 09EINE4500, 09EINE4502, 09EINE4528, 09EINE4563, 09EINE4574, 09EINE4599, 09EINE4605, 09EINE4637, 09EINE4641, 09EINE4654, 09EINE4675, 09EINE4711, 09EINE8759, 09EINE8758, 09EINE8755, 09EINE8750, 09EINE8766, 09EINE8801, 09EINE8851, 09EINE8857, 09EINE8898, 09EINE8919, 09EINE8927, 09EINE8935, 09EINE8947, 09EINE8968, 09EINE8982, 09EINE8998, 09EINE9007, 09EINE9063, 09EINE9068, 09EINE9059, 09EINE9085, 09EINE9120, 09EINE9116, 09EINE9152, 09EINE9206, 09EINE9215, 09EINE9216, 09EINE9228, 09EINE9299, 09EINE9298, 09EINE9307, 09EINE9322, 09EINE9361, 09EINE9368, 09EINE9394, 09EINE8725, 09EINF0223, 09EINF1004, 09EINF1137, 09EINF1376, 09EINF1632, 09EINF1654, 09EINF1668, 09EINF1691, 09EINF1692, 09EINF1710, 09EINF1751, 09EINF1765, 09EINF1786, 09EINF1808, 09EINF1804, 09EINF1833, 09EINF1853, 09EINF1870, 09EINF1904, 09EINF1901, 09EINF1944, 09EINF2001, 09EINF2021, 09EINF2018, 09EINF2027, 09EINF2052, 09EINF2048, 09EINF2056, 09EINF2072, 09EINF2090, 09EINF2095, 09EINF1456, 09EINF1606, 09EINF2164, 09EINF2178, 09EINF2172, 09EINF2208, 09EINF2278, 09EINF2302, 09EINF2325, 09EINF2344, 09EINF2346, 09EINF2353, 09EINF2446, 09EINF2458, 09EINF2528, 09EINF2559, 09EINF2614, 09EINF2612, 09EINF2611, 09EINF2621, 09EINF2632, 09EINF2652, 09EINF2645, 09EINF2695, 09EINF2687, 09EINF2706, 09EINF2723, 09EINF2717, 09EINF2751, 09EINF2756, 09EINF2771, 09EINF2800, 09EINF2815, 09EINF2829, 09EINF2845, 09EINF2856, 09EINF2867, 09EINF2879, 09EINF2938, 09EINF2940, 09EINF2964, 09EINF2978, 09EINF2969, 09EINF2994, 09EINF3007, 09EINF3001, 09EINF1953, 09EINF3101, 09EINF3116, 09EINF3126, 09EINF3193, 09EINF3201, 09EINF3219, 09EINF3217, 09EINF3231, 09EINF3267, 09EINF3285, 09EINF3297, 09EINF3331, 09EINF3332, 09EINF3366, 09EINF3378, 09EINF3383, 09EINF3408, 09EINF3410, 09EINF3404, 09EINF3418, 09EINF3443, 09EINF3455, 09EINF3469, 09EINF3493, 09EINF3515, 09EINF3513, 09EINF3540, 09EINF3593, 09EINF3602, 09EINF3596, 09EINF3606, 09EINF3624, 09EINF3633, 09EINF3625, 09EINF3686, 09EINF3725, 09EINF3735, 09EINF3740, 09EINF3752, 09EINF3796, 09EINF3814, 09EINF3824, 09EINF3853, 09EINF3851, 09EINF3847, 09EINF3863, 09EINF3870, 09EINF3856, 09EINF3895, 09EINF3909, 09EINF3898, 09EINF3925, 09EINF3930, 09EINF3954, 09EINF3991, 09EINF4009, 09EINF4018, 09EINF4008, 09EINF4045, 09EINF4042, 09EINF4075, 09EINF4114, 09EINF4134, 09EINF4166, 09EINF4174, 09EINE6390, 09EINE6540, 09EINE6568, 09EINE6559, 09EINE6606, 09EINE6596, 09EINE6621, 09EINE6626, 09EINE6628, 09EINE6641, 09EINE6670, 09EINE6720, 09EINE6721, 09EINE6748, 09EINE6768, 09EINE6762, 09EINE6771, 09EINE6783, 09EINE6796, 09EINE6804, 09EINE6807, 09EINE6821, 09EINE6819, 09EINE6837, 09EINE6827, 09EINE6844, 09EINE6885, 09EINE6908, 09EINE6914, 09EINE6916, 09EINE6934, 09EINE6946, 09EINE6958, 09EINE7010, 09EINE7053, 09EINE7052, 09EINE7075, 09EINE7090, 09EINE7085, 09EINE7094, 09EINE7162, 09EINE7175, 09EINE7246, 09EINE7263, 09EINE7279, 09EINE7310, 09EINE7327, 09EINE7319, 09EINE7328, 09EINE7336, 09EINE7332, 09EINE7363, 09EINE7411, 09EINE7407, 09EINE7421, 09EINE7423, 09EINE7456, 09EINE7447, 09EINE7469, 09EINE7467, 09EINE7505, 09EINE7509, 09EINE7528, 09EINE7559, 09EINE7588, 09EINE7618, 09EINE7626, 09EINE7651, 09EINE7670, 09EINE7686, 09EINE7711, 09EINE7707, 09EINE7719, 09EINE4835, 09EINE6678, 09EINE7813, 09EINE7837, 09EINE7848, 09EINE7850, 09EINE7860, 09EINE7869, 09EINE7877, 09EINE7895, 09EINE7898, 09EINE7907, 09EINE7919, 09EINE7932, 09EINE7970, 09EINE7962, 09EINE7959, 09EINE7977, 09EINE7991, 09EINE8007, 09EINE8027, 09EINE8031, 09EINE8043, 09EINE8033, 09EINE8066, 09EINE8131, 09EINE8181, 09EINE8161, 09EINE8191, 09EINE7760, 09EINE7983, 09EINE8120, 09EINE8201, 09EINE8214, 09EINE8223, 09EINE8229, 09EINE8236, 09EINE8241, 09EINE8261, 09EINE8270, 09EINE8293, 09EINE8289, 09EINE8365, 09EINE8364, 09EINE8368, 09EINE8374, 09EINE8394, 09EINE8406, 09EINE8429, 09EINE8468, 09EINE8477, 09EINE8491, 09EINE8492, 09EINE8526, 09EINE8524, 09EINE8537, 09EINE8560, 09EINE8593, 09EINE8620, 09EINE8613, 09EINE8656, 09EINE8663, 09EINE8673, 09EINE8699, 09EINE8722, 09EINE7842, 09EINE8036, 09EINE8350, 09EINE8396, 09EINE8437, 09EINE8487, 09EINE8644, 09EINE9038, 09EINE9076, 09EINE9420, 09EINE9477, 09EINE9476, 09EINE9489, 09EINE9502, 09EINE9503, 09EINE9516, 09EINE9538, 09EINE9529, 09EINE9525, 09EINE9526, 09EINE9566, 09EINE9600, 09EINE9619, 09EINE9622, 09EINE9631, 09EINE9633, 09EINE9658, 09EINE9699, 09EINE9719, 09EINE9763, 09EINE9768, 09EINE9783, 09EINE9779, 09EINE9814, 09EINE9842, 09EINE9860, 09EINE9864, 09EINE9870, 09EINE9865, 09EINE9867, 09EINE9884, 09EINE9923, 09EINE9950, 09EINE9953, 09EINE9984, 09EINF0001, 09EINF0010, 09EINF0042, 09EINF0060, 09EINF0066, 09EINF0074, 09EINF0106, 09EINF0103, 09EINF0100, 09EINF0099, 09EINF0107, 09EINF0166, 09EINF0175, 09EINF0172, 09EINF0174, 09EINF0195, 09EINF0201, 09EINF0203, 09EINF0213, 09EINF0227, 09EINF0230, 09EINF0259, 09EINF0276, 09EINF0289, 09EINF0301, 09EINF0308, 09EINF0300, 09EINF0311, 09EINF0325, 09EINF0337, 09EINF0341, 09EINF0347, 09EINF0431, 09EINF0415, 09EINF0450, 09EINF0468, 09EINF0474, 09EINF0471, 09EINF0490, 09EINF0491, 09EINF0560, 09EINF0571, 09EINF0578, 09EINF0617, 09EINF0619, 09EINE3917, 09EINF0625, 09EINF0620, 09EINF0706, 09EINF0729, 09EINF0774, 09EINF0777, 09EINF0785, 09EINF0790, 09EINF0814, 09EINF0832, 09EINF0877, 09EINF0871, 09EINF0886, 09EINF0899, 09EINF0920, 09EINF0931, 09EINF0933, 09EINF0937, 09EINF0942, 09EINF0971, 09EINF1001, 09EINF0998, 09EINF0994, 09EINF1021, 09EINF1042, 09EINF1077, 09EINF1085, 09EINF1096, 09EINF1112, 09EINF1118, 09EINF1117, 09EINF1131, 09EINF1186, 09EINF1233, 09EINF1243, 09EINF1265, 09EINF1270, 09EINF1303, 09EINF1313, 09EINF1326, 09EINF1350, 09EINF1371, 09EINF1387, 09EINF1392, 09EINF1405, 09EINF1435, 09EINF1480, 09EINF1472, 09EINF1505, 09EINF1500, 09EINF1522, 09EINF1521, 09EINF1532, 09EINF1529, 09EINF1537, 09EINF1576, 09EINF1584, 09EINF1586, 09EINF1601, 09EINE1317, 09EINE0564, 09EINE1840, 09EINE1875, 09EINE1871, 09EINE1877, 09EINE1891, 09EINE1895, 09EINE1920, 09EINE1928, 09EINE1943, 09EINE1965, 09EINE1966, 09EINE1981, 09EINE1977, 09EINE1993, 09EINE2001, 09EINE2031, 09EINE2047, 09EINE2104, 09EINE0672, 09EINE1099, 09EINE1208, 09EINE1579, 09EINE1915, 09EINE1986, 09EINE1949, 09EINE2082, 09EINE2140, 09EINE2135, 09EINE2156, 09EINE2164, 09EINE2203, 09EINE2206, 09EINE2223, 09EINE2235, 09EINE2247, 09EINE2251, 09EINE2270, 09EINE2265, 09EINE2292, 09EINE2312, 09EINE2308, 09EINE2339, 09EINE2331, 09EINE2356, 09EINE2357, 09EINE2375, 09EINE2388, 09EINE2402, 09EINE2465, 09EINE2462, 09EINE2481, 09EINE2478, 09EINE2491, 09EINE2486, 09EINE2546, 09EINE2545, 09EINE2554, 09EINE2558, 09EINE2561, 09EINE2564, 09EINE2612, 09EINE2622, 09EINE2659, 09EINE2650, 09EINE2661, 09EINE2667, 09EINE2691, 09EINE2687, 09EINE2716, 09EINE2738, 09EINE2767, 09EINE2771, 09EINE2776, 09EINE2788, 09EINE2802, 09EINE2804, 09EINE2817, 09EINE2823, 09EINE2830, 09EINE2822, 09EINE2875, 09EINE2872, 09EINE2870, 09EINE2901, 09EINE2905, 09EINE2930, 09EINE2937, 09EINE2940, 09EINE2948, 09EINE2954, 09EINE2957, 09EINE2964, 09EINE2985, 09EINE2348, 09EINE3000, 09EINE3021, 09EINE3036, 09EINE3078, 09EINE3121, 09EINE3132, 09EINE3131, 09EINE3168, 09EINE3180, 09EINE3191, 09EINE3201, 09EINE2422, 09EINE3028, 09EINE2881, 09EINE3261, 09EINE3265, 09EINE3273, 09EINE3307, 09EINE3321, 09EINE3319, 09EINE3317, 09EINE3346, 09EINE3355, 09EINE3365, 09EINE3378, 09EINE3377, 09EINE3388, 09EINE3391, 09EINE3418, 09EINE3461, 09EINE3482, 09EINE3483, 09EINE3539, 09EINE3532, 09EINE3542, 09EINE3546, 09EINE3559, 09EINE3578, 09EINE3595, 09EINE3630, 09EINE3631, 09EINE3633, 09EINE3656, 09EINE3677, 09EINE3698, 09EINE3692, 09EINE3744, 09EINE3750, 09EINE3752, 09EINE3785, 09EINE3779, 09EINE3781, 09EINE3787, 09EINE3792, 09EINE3821, 09EINE3862, 09EINE3897, 09EINE3899, 09EINE3925, 09EINE3934, 09EINE3933, 09EINE3944, 09EINE3963, 09EINE3966, 09EINE3992, 09EINE4009, 09EINE4011, 09EINE4001, 09EINE4015, 09EINE4029, 09EINE4042, 09EINE4038, 09EINE4047, 09EINE4058, 09EINE4055, 09EINE4072, 09EINE4081, 09EINE4139, 09EINE4153, 09EINE4168, 09EINE4182, 09EINE4191, 09EINE4197, 09EINE3727, 09EINE3815, 09EINE4765, 09EINE3344, 09EINE3543, 09EINE3883, 09EINE4776, 09EINE4084, 09EINE4779, 09EINE4788, 09EINE4799, 09EINE4827, 09EINE4816, 09EINE4823, 09EINE4821, 09EINE4834, 09EINE4848, 09EINE4868, 09EINE4941, 09EINE4933, 09EINE4964, 09EINE5031, 09EINE5037, 09EINE5025, 09EINE5027, 09EINE5039, 09EINE5074, 09EINE5092, 09EINE5135, 09EINE5176, 09EINE5180, 09EINE5183, 09EINE5211, 09EINE5217, 09EINE5212, 09EINE5245, 09EINE5234, 09EINE5246, 09EINE5254, 09EINE5256, 09EINE5261, 09EINE5280, 09EINE2461, 09EINE4251, 09EINE4885, 09EINE5306, 09EINE5315, 09EINE5319, 09EINE5347, 09EINE5350, 09EINE5369, 09EINE5377, 09EINE5399, 09EINE5417, 09EINE5426, 09EINE5431, 09EINE5436, 09EINE5438, 09EINE5455, 09EINE5452, 09EINE5458, 09EINE5466, 09EINE5497, 09EINE5505, 09EINE5571, 09EINE5588, 09EINE5603, 09EINE5678, 09EINE5698, 09EINE5695, 09EINE5713, 09EINE5739, 09EINE5756, 09EINE5754, 09EINE5775, 09EINE5768, 09EINE5822, 09EINE5820, 09EINE5836, 09EINE5853, 09EINE5866, 09EINE5873, 09EINE5878, 09EINE5890, 09EINE5910, 09EINE5913, 09EINE5930, 09EINE5943, 09EINE5945, 09EINE5952, 09EINE5964, 09EINE6000, 09EINE6033, 09EINE6042, 09EINE6059, 09EINE6081, 09EINE6117, 09EINE6131, 09EINE6130, 09EINE6176, 09EINE6228, 09EINE6256, 09EINE6257, 09EINE6285, 09EINE6278, 09EINE6308, 09EINE6328, 09EINE6320, 09EINE6345, 09EINE6347, 09EINE6366, 09EINE2009, 09EINE6367, 09EINE6454, 09EINE6453, 09EINE6457, 09EINE6494, 09EIND6633, 09EIND2175, 09EIND7338, 09EIND7326, 09EIND7353, 09EIND7426, 09EIND7404, 09EIND7427, 09EIND7449, 09EIND7442, 09EIND7492, 09EIND7506, 09EIND7550, 09EIND7546, 09EIND7565, 09EIND7579, 09EIND7592, 09EIND7669, 09EIND7681, 09EIND7682, 09EIND7694, 09EIND7705, 09EIND7734, 09EIND7745, 09EIND7738, 09EIND7783, 09EIND7815, 09EIND7806, 09EIND7833, 09EIND7849, 09EIND7864, 09EIND7871, 09EIND7869, 09EIND7909, 09EIND7904, 09EIND7908, 09EIND7930, 09EIND7944, 09EIND7925, 09EIND7920, 09EIND7924, 09EIND7961, 09EIND7952, 09EIND7971, 09EIND7958, 09EIND7977, 09EIND5094, 09EIND7996, 09EIND7979, 09EIND8034, 09EIND8030, 09EIND8041, 09EIND8042, 09EIND8068, 09EIND8102, 09EIND8079, 09EIND8078, 09EIND8109, 09EIND8139, 09EIND8143, 09EIND8184, 09EIND8196, 09EIND8197, 09EIND8242, 09EIND8245, 09EIND8246, 09EIND8317, 09EIND8329, 09EIND8311, 09EIND8340, 09EIND8358, 09EIND8397, 09EIND8401, 09EIND8416, 09EIND8457, 09EIND8466, 09EIND8494, 09EIND8501, 09EIND8491, 09EIND8507, 09EIND8498, 09EIND8488, 09EIND8536, 09EIND8539, 09EIND8586, 09EIND8577, 09EIND8585, 09EIND8584, 09EIND8578, 09EIND8616, 09EIND8614, 09EIND8619, 09EIND8631, 09EIND8641, 09EIND8637, 09EIND8666, 09EIND8661, 09EIND8711, 09EIND8745, 09EIND8752, 09EIND8738, 09EIND8755, 09EIND8766, 09EIND8768, 09EIND8788, 09EIND8817, 09EIND8854, 09EIND8869, 09EIND8885, 09EIND8907, 09EIND8911, 09EIND8919, 09EIND8936, 09EIND8958, 09EIND8947, 09EIND8956, 09EIND8949, 09EIND8988, 09EIND9045, 09EIND9041, 09EIND9068, 09EIND9092, 09EIND9071, 09EIND9156, 09EIND9162, 09EIND9141, 09EIND9198, 09EIND9175, 09EIND9194, 09EIND9222, 09EIND9234, 09EIND9262, 09EIND9289, 09EIND9311, 09EIND9325, 09EIND9309, 09EIND9312, 09EIND9349, 09EIND9354, 09EIND9402, 09EIND9393, 09EIND9390, 09EIND9392, 09EIND9414, 09EIND9412, 09EIND9422, 09EIND7481, 09EIND7844, 09EIND8954, 09EIND9430, 09EIND9452, 09EIND9496, 09EIND9512, 09EIND9565, 09EIND9571, 09EIND9601, 09EIND9587, 09EIND7574, 09EIND9614, 09EIND8634, 09EIND9613, 09EIND8547, 09EIND9617, 09EIND9629, 09EIND9624, 09EIND9621, 09EIND9636, 09EIND9653, 09EIND9666, 09EIND9685, 09EIND9679, 09EIND9716, 09EIND9723, 09EIND9713, 09EIND9742, 09EIND9762, 09EIND9799, 09EIND9805, 09EIND9818, 09EIND9819, 09EIND9832, 09EIND9836, 09EIND9840, 09EIND9879, 09EIND9856, 09EIND9896, 09EIND9959, 09EIND9948, 09EIND9966, 09EIND9980, 09EIND9990, 09EIND9994, 09EINE0017, 09EINE0019, 09EINE0003, 09EINE0029, 09EIND9821, 09EINE0048, 09EINE0054, 09EINE0078, 09EINE0073, 09EINE0064, 09EINE0107, 09EINE0095, 09EINE0099, 09EINE0136, 09EINE0146, 09EINE0124, 09EINE0169, 09EINE0151, 09EINE0182, 09EINE0211, 09EINE0223, 09EINE0220, 09EINE0224, 09EINE0251, 09EINE0246, 09EINE0244, 09EINE0267, 09EINE0280, 09EINE0272, 09EINE0295, 09EINE0349, 09EINE0337, 09EINE0354, 09EINE0393, 09EINE0387, 09EINE0400, 09EINE0434, 09EINE0445, 09EINE0462, 09EINE0453, 09EINE0452, 09EINE0479, 09EINE0510, 09EINE0507, 09EINE0501, 09EINE0497, 09EINE0515, 09EINE0560, 09EINE0570, 09EIND9329, 09EINE0116, 09EINE0433, 09EINE0457, 09EINE0481, 09EINE0488, 09EINE0643, 09EINE0652, 09EINE0665, 09EINE0685, 09EINE0727, 09EINE0735, 09EINE0784, 09EINE0775, 09EINE0777, 09EINE0803, 09EINE0798, 09EINE0786, 09EINE0828, 09EINE0835, 09EINE0833, 09EINE0841, 09EINE0852, 09EINE0864, 09EINE0866, 09EINE0877, 09EINE0882, 09EINE0863, 09EINE0911, 09EINE0890, 09EINE0893, 09EINE0919, 09EINE0939, 09EINE0986, 09EINE1013, 09EINE1024, 09EINE1020, 09EINE1012, 09EINE1003, 09EINE1028, 09EINE1083, 09EINE1071, 09EINE1082, 09EINE1123, 09EINE1102, 09EINE1114, 09EINE1111, 09EINE1113, 09EINE1119, 09EINE1140, 09EINE1146, 09EINE1182, 09EINE1216, 09EINE1250, 09EINE1293, 09EIND2160, 09EIND2163, 09EIND2161, 09EINC9500, 09EIND1623, 09EIND0706, 09EIND1792, 09EIND2170, 09EIND1887, 09EIND1975, 09EIND2109, 09EIND2216, 09EIND2224, 09EIND2239, 09EIND2223, 09EIND2264, 09EIND2278, 09EIND2303, 09EIND2319, 09EIND2342, 09EIND2377, 09EIND2388, 09EIND2389, 09EIND2382, 09EIND2381, 09EIND2407, 09EIND2418, 09EIND2421, 09EIND2428, 09EIND2420, 09EIND2450, 09EIND2463, 09EIND2473, 09EIND2533, 09EIND2522, 09EIND2528, 09EIND2543, 09EIND2596, 09EIND2586, 09EIND2601, 09EIND2621, 09EIND2602, 09EIND2625, 09EIND2639, 09EIND2651, 09EIND2636, 09EIND2699, 09EIND2711, 09EIND2706, 09EIND2789, 09EIND2775, 09EIND2791, 09EIND2818, 09EIND2821, 09EINC2894, 09EIND2839, 09EIND1826, 09EIND1904, 09EIND2273, 09EIND2668, 09EIND2868, 09EIND2890, 09EIND2895, 09EIND2913, 09EIND2894, 09EIND2886, 09EIND2897, 09EIND2901, 09EIND2941, 09EIND2926, 09EIND2943, 09EIND2959, 09EIND2952, 09EIND2954, 09EIND2983, 09EIND3004, 09EIND2996, 09EIND2997, 09EIND3008, 09EIND3021, 09EIND3036, 09EIND3054, 09EIND3055, 09EIND3048, 09EIND3035, 09EIND3042, 09EIND3043, 09EIND3067, 09EIND3066, 09EIND3111, 09EIND3123, 09EIND3157, 09EIND3144, 09EIND3146, 09EIND3201, 09EIND3200, 09EIND3218, 09EIND3204, 09EIND3224, 09EIND3254, 09EIND3256, 09EIND3270, 09EIND3305, 09EIND3306, 09EIND3312, 09EIND3348, 09EIND3351, 09EIND3375, 09EIND3406, 09EIND3385, 09EIND3386, 09EIND3453, 09EIND3468, 09EIND3464, 09EIND3465, 09EIND3484, 09EIND3481, 09EIND3480, 09EIND3475, 09EIND3494, 09EIND3513, 09EIND3506, 09EIND3545, 09EIND3542, 09EIND3546, 09EIND3573, 09EIND3612, 09EIND3627, 09EIND3618, 09EIND3645, 09EIND3657, 09EIND3662, 09EIND3652, 09EIND3675, 09EIND3685, 09EIND3686, 09EIND3676, 09EIND3732, 09EIND3726, 09EIND3709, 09EIND3741, 09EIND3740, 09EIND3750, 09EIND3763, 09EIND3751, 09EIND3796, 09EIND3799, 09EIND3831, 09EIND3817, 09EIND3875, 09EIND3847, 09EIND3864, 09EIND3869, 09EIND3908, 09EIND3882, 09EIND3924, 09EIND3926, 09EIND3951, 09EIND3976, 09EIND3977, 09EIND4004, 09EIND4027, 09EIND4014, 09EIND4054, 09EIND4043, 09EIND3925, 09EIND3877, 09EIND4066, 09EIND4077, 09EIND4055, 09EIND4018, 09EIND4095, 09EIND4098, 09EIND4144, 09EIND4123, 09EIND4155, 09EIND4194, 09EIND4227, 09EIND4238, 09EIND4214, 09EIND4204, 09EIND4247, 09EIND4279, 09EIND4268, 09EIND4285, 09EIND4316, 09EIND4300, 09EIND4317, 09EIND4324, 09EIND4356, 09EIND4391, 09EIND4430, 09EIND4433, 09EIND4413, 09EIND4427, 09EIND4450, 09EIND4449, 09EIND4447, 09EIND4473, 09EIND4468, 09EIND4481, 09EIND4528, 09EIND4510, 09EIND4497, 09EIND4506, 09EIND4508, 09EIND4541, 09EIND4540, 09EIND2222, 09EIND3365, 09EIND3412, 09EIND4544, 09EIND4559, 09EIND4574, 09EIND4562, 09EIND4592, 09EIND4596, 09EIND4648, 09EIND4660, 09EIND4651, 09EIND4685, 09EIND4706, 09EIND4730, 09EIND4750, 09EIND4759, 09EIND4748, 09EIND4754, 09EIND4772, 09EIND4827, 09EIND4901, 09EIND4886, 09EIND4955, 09EIND4989, 09EIND5003, 09EIND4990, 09EIND5012, 09EIND5076, 09EIND5063, 09EIND5035, 09EIND5103, 09EIND5106, 09EIND5144, 09EIND5127, 09EIND5116, 09EIND5176, 09EIND5165, 09EIND5155, 09EIND5172, 09EIND5189, 09EIND5201, 09EIND5220, 09EIND5228, 09EIND5209, 09EIND5253, 09EIND5251, 09EIND5247, 09EIND5306, 09EIND4446, 09EIND3581, 09EIND3674, 09EIND5088, 09EIND4808, 09EIND4824, 09EIND5204, 09EIND5231, 09EIND5297, 09EIND5318, 09EIND5325, 09EIND5293, 09EIND5347, 09EIND5365, 09EIND5371, 09EIND5385, 09EIND5408, 09EIND5397, 09EIND5444, 09EIND5466, 09EIND5509, 09EIND5514, 09EIND5502, 09EIND5548, 09EIND5540, 09EIND5527, 09EIND5547, 09EIND5543, 09EIND5561, 09EIND5586, 09EIND5601, 09EIND5610, 09EIND5605, 09EIND5633, 09EIND3549, 09EIND4550, 09EIND5162, 09EIND4791, 09EIND5675, 09EIND5663, 09EIND5696, 09EIND5699, 09EIND5686, 09EIND5748, 09EIND5749, 09EIND5737, 09EIND5776, 09EIND5761, 09EIND5792, 09EIND5799, 09EIND5833, 09EIND5820, 09EIND5860, 09EIND5835, 09EIND5876, 09EIND5904, 09EIND5905, 09EIND5892, 09EIND5910, 09EIND5913, 09EIND5951, 09EIND5968, 09EIND5987, 09EIND6003, 09EIND5986, 09EIND6015, 09EIND6023, 09EIND6035, 09EIND6105, 09EIND6099, 09EIND6112, 09EIND6175, 09EIND6168, 09EIND6176, 09EIND6184, 09EIND6209, 09EIND6214, 09EIND6237, 09EIND6243, 09EIND6262, 09EIND6284, 09EIND6272, 09EIND6296, 09EIND6315, 09EIND6290, 09EIND6365, 09EIND6360, 09EIND6345, 09EIND6381, 09EIND6374, 09EIND6415, 09EIND6425, 09EIND6426, 09EIND6435, 09EIND6448, 09EIND6461, 09EIND6455, 09EIND6457, 09EIND6478, 09EIND6480, 09EIND6479, 09EIND6488, 09EIND6485, 09EIND6511, 09EIND6498, 09EIND6535, 09EIND6543, 09EIND6554, 09EIND6566, 09EIND6579, 09EIND6572, 09EIND6597, 09EIND6619, 09EINA7247, 09EINA7240, 09EINA7232, 09EINA7262, 09EINA7270, 09EINA7297, 09EINA7284, 09EINA7298, 09EINA7306, 09EINA7331, 09EINA7368, 09EINA7372, 09EINA7386, 09EINA7351, 09EINA7405, 09EINA7408, 09EINA7403, 09EINA7449, 09EINA7479, 09EINA7482, 09EINA7488, 09EINA7498, 09EINA7524, 09EINA7554, 09EINA7576, 09EINA7559, 09EINA7566, 09EINA7602, 09EINA7578, 09EINA7619, 09EINA7634, 09EINA7651, 09EINA7652, 09EINA7686, 09EINA7685, 09EINA7674, 09EINA7699, 09EINA7735, 09EINA7745, 09EINA7721, 09EINA7767, 09EINA7809, 09EINA7803, 09EINA7807, 09EINA7790, 09EINA7843, 09EINA7826, 09EINA7871, 09EINA7859, 09EINA7846, 09EINA7899, 09EINA7903, 09EINA7933, 09EINA7932, 09EINA7922, 09EINA7939, 09EINA7938, 09EINA8000, 09EINA7999, 09EINA7990, 09EINA8013, 09EINA8030, 09EINA8025, 09EINA8022, 09EINA8053, 09EINA8055, 09EINA5372, 09EINA8072, 09EINA8087, 09EINA8089, 09EINA8091, 09EINA8098, 09EINA8099, 09EINA8113, 09EINA8140, 09EINA8158, 09EINA8149, 09EINA8161, 09EINA8173, 09EINA8199, 09EINA8240, 09EINA8236, 09EINA8284, 09EINA8275, 09EINA8311, 09EINA8326, 09EINA8313, 09EINA8323, 09EINA8316, 09EINA8403, 09EINA8374, 09EINA8366, 09EINA8398, 09EINA8422, 09EINA8415, 09EINA8459, 09EINA8480, 09EINA8482, 09EINA8464, 09EINA8513, 09EINA8556, 09EINA8570, 09EINA8600, 09EINA8652, 09EINA8661, 09EINA8677, 09EINB7351, 09EINB7375, 09EINB7378, 09EINB7376, 09EINB7429, 09EINB7425, 09EINB7452, 09EINB7478, 09EINB7493, 09EINB7527, 09EINB7504, 09EINB7508, 09EINB7564, 09EINB7563, 09EINB7568, 09EINB7601, 09EINB7610, 09EINB7583, 09EINB7604, 09EINB7607, 09EINB7608, 09EINB7621, 09EINB7654, 09EINB7709, 09EINB7737, 09EINB7743, 09EINB7781, 09EINB7796, 09EINB7822, 09EINB7793, 09EINB7858, 09EINB7843, 09EINB7861, 09EINB7878, 09EINB7862, 09EINB7876, 09EINB7911, 09EINB7908, 09EINB7921, 09EINB7953, 09EINB7981, 09EINB8025, 09EINB8033, 09EINB8030, 09EINB8053, 09EINB8049, 09EINB8085, 09EINB8080, 09EINB8097, 09EINB8116, 09EINB8149, 09EINB8188, 09EINB8189, 09EINB8185, 09EINB8192, 09EINB8198, 09EINB8206, 09EINB8207, 09EINB8212, 09EINB8204, 09EINB7938, 09EINB8270, 09EINB8298, 09EINB8316, 09EINB8310, 09EINB8318, 09EINB8325, 09EINB8329, 09EINB8359, 09EINB6219, 09EINB7158, 09EINB7688, 09EINB7821, 09EINB8250, 09EINB8069, 09EINB8361, 09EINB8302, 09EINB8334, 09EINB8264, 09EINB8365, 09EINB8392, 09EINB8401, 09EINB8399, 09EINB8426, 09EINB8414, 09EINB8441, 09EINB8442, 09EINB8456, 09EINB8484, 09EINB8477, 09EINB8492, 09EINB8485, 09EINB8538, 09EINB8543, 09EINB8537, 09EINB8575, 09EINB8592, 09EINB8598, 09EINB8609, 09EINB8624, 09EINB8634, 09EINB8655, 09EINB8707, 09EINB8690, 09EINB8743, 09EINB8756, 09EINB8813, 09EINB8805, 09EINB8802, 09EINB8797, 09EINB8827, 09EINB8856, 09EINB5693, 09EINB8885, 09EINB8880, 09EINB8911, 09EINB8904, 09EINB8903, 09EINB8922, 09EINB8937, 09EINB7943, 09EINB8993, 09EINB8969, 09EINB8978, 09EINB9008, 09EINB9040, 09EINB9059, 09EINB9076, 09EINB5600, 09EINB9086, 09EINB9129, 09EINB9116, 09EINB9130, 09EINB9103, 09EINB9113, 09EINB9089, 09EINB9141, 09EINB9149, 09EINB9142, 09EINB9187, 09EINB9177, 09EINB9190, 09EINB9202, 09EINB9250, 09EINB9268, 09EINB9300, 09EINB9296, 09EINB9303, 09EINB9347, 09EINB9324, 09EINB9356, 09EINB9330, 09EINB9375, 09EINB9386, 09EINB9416, 09EINB9404, 09EINB9405, 09EINB9412, 09EINB9431, 09EINB9435, 09EINB9451, 09EINB9501, 09EINB9504, 09EINB9478, 09EINB9477, 09EINB9515, 09EINB9530, 09EINB9527, 09EINB8375, 09EINB9558, 09EINB9584, 09EINB9609, 09EINB9618, 09EINB9614, 09EINB9613, 09EINB9615, 09EINB9605, 09EINB9642, 09EINB9629, 09EINB9634, 09EINB9670, 09EINB9658, 09EINB9689, 09EINB9686, 09EINB9752, 09EINB9779, 09EINB9781, 09EINB9782, 09EINB9846, 09EINB9820, 09EINB9833, 09EINB9852, 09EINB9870, 09EINB9862, 09EINB9887, 09EINB9897, 09EINB9912, 09EINB9946, 09EINB9937, 09EINB9954, 09EINB9962, 09EINB9980, 09EINB9981, 09EINC0001, 09EINC0021, 09EINB9997, 09EINC0037, 09EINC0044, 09EINC0077, 09EINC0081, 09EINC0068, 09EINC0069, 09EINC0108, 09EINC0103, 09EINB2710, 09EINC0117, 09EINB9580, 09EINC0152, 09EINC0129, 09EINC0131, 09EINC0173, 09EINC0183, 09EINC0171, 09EINC0192, 09EINC0223, 09EINC0216, 09EINC0249, 09EINC0265, 09EINC0283, 09EINC0294, 09EINC0277, 09EINC0316, 09EINC0348, 09EINC0347, 09EINC0372, 09EINC0401, 09EINC0399, 09EINC0449, 09EINC0454, 09EINC0482, 09EINC0474, 09EINC0461, 09EINC0498, 09EINC0505, 09EINC0524, 09EINC0521, 09EINC0510, 09EINC0526, 09EINC0528, 09EINC0597, 09EINC0593, 09EINC0590, 09EINC0610, 09EINC0615, 09EINC0659, 09EINC0648, 09EINC0649, 09EINC0641, 09EINC0193, 09EINC0274, 09EINC0343, 09EINC0451, 09EINC0652, 09EINC0700, 09EINC0692, 09EINC0721, 09EINC0722, 09EINC0727, 09EINC0764, 09EINC0748, 09EINC0755, 09EINC0808, 09EINC0819, 09EINC0836, 09EINC0813, 09EINC0860, 09EINC0857, 09EINC0854, 09EINC0869, 09EINC0848, 09EINC0897, 09EINC0878, 09EINC0921, 09EINC0960, 09EINC0949, 09EINC0992, 09EINC0974, 09EINC0993, 09EINC0969, 09EINC1016, 09EINC1041, 09EINC1025, 09EINC1024, 09EINC0724, 09EINC0978, 09EINC1000, 09EINC1063, 09EINC1061, 09EINC1055, 09EINC1065, 09EINC1114, 09EINC1107, 09EINC1127, 09EINC0476, 09EINC1139, 09EINC0955, 09EINC1018, 09EINC1157, 09EINC1187, 09EINC1183, 09EINC1172, 09EINC1236, 09EINC1209, 09EINC1214, 09EINC1217, 09EINC1234, 09EINC1243, 09EINC1258, 09EINC1287, 09EINC1321, 09EINC1319, 09EINC1300, 09EINC1306, 09EINC1318, 09EINC1383, 09EINC1403, 09EINC1385, 09EINC1423, 09EINC1441, 09EINC1432, 09EINC1415, 09EINC1421, 09EINC1427, 09EINC1483, 09EINC1497, 09EINC1520, 09EINC1533, 09EINC1543, 09EINC1512, 09EINC1528, 09EINC1562, 09EINC1607, 09EINC1611, 09EINC1636, 09EINC1620, 09EINC1621, 09EINC1671, 09EINC1669, 09EINC1661, 09EINC1695, 09EINC1692, 09EINC1719, 09EINC1740, 09EINC1725, 09EINC1771, 09EINC1757, 09EINC1775, 09EINC1785, 09EINB8649, 09EINC1831, 09EINC1849, 09EINC1860, 09EINC1867, 09EINC1858, 09EINC1898, 09EINC1910, 09EINC1888, 09EINC1914, 09EINC1936, 09EINC1932, 09EINC1976, 09EINC1989, 09EINC2009, 09EINC1982, 09EINC1991, 09EINC2000, 09EINC2037, 09EINC2022, 09EINC2061, 09EINC2073, 09EINC2080, 09EINC2092, 09EINC2095, 09EINC2120, 09EINC2108, 09EINC2134, 09EINC2155, 09EINC2171, 09EINC2153, 09EINC2165, 09EINC2191, 09EINC2218, 09EINC2183, 09EINC2192, 09EINC2248, 09EINC2225, 09EINC2263, 09EINC2260, 09EINC2258, 09EINC2289, 09EINC2299, 09EINC2309, 09EINC2350, 09EINC2334, 09EINC2347, 09EINC2318, 09EINC2366, 09EINC0707, 09EINC2342, 09EINC1059, 09EINC1903, 09EINC2445, 09EINC2433, 09EINC2489, 09EINC2484, 09EINC2521, 09EINC2504, 09EINC2499, 09EINC2530, 09EINC2540, 09EINC2537, 09EINC2539, 09EINC2549, 09EINC2573, 09EINC2578, 09EINC2584, 09EINC2580, 09EINC2613, 09EINC2616, 09EINC2645, 09EINC2646, 09EINC2649, 09EINC2651, 09EINC2697, 09EINC2683, 09EINC2679, 09EINC2695, 09EINC2680, 09EINC2716, 09EINC2721, 09EINC2710, 09EINC2709, 09EINC2711, 09EINC2739, 09EINC2747, 09EINC2749, 09EINC2769, 09EINC2802, 09EINC2821, 09EINC2837, 09EINC2851, 09EINC2831, 09EINC2863, 09EINC2901, 09EINC2930, 09EINC2922, 09EINC2951, 09EINC2961, 09EINC2991, 09EINC3025, 09EINC3016, 09EINC3013, 09EINC2998, 09EINC3111, 09EINC3131, 09EINC3139, 09EINC3134, 09EINC3170, 09EINC3159, 09EINC3160, 09EINC3182, 09EINC3235, 09EINC3243, 09EINC3239, 09EINC3266, 09EINC3256, 09EINC3301, 09EINC3298, 09EINC3313, 09EINC3338, 09EINC3330, 09EINB9326, 09EINC3102, 09EINC3116, 09EINC3189, 09EINC3360, 09EINC3347, 09EINC3364, 09EINC3372, 09EINC3386, 09EINC3382, 09EINC3419, 09EINC3430, 09EINC3445, 09EINC3424, 09EINC3455, 09EINC3482, 09EINC3483, 09EINC3513, 09EINC3542, 09EINC3536, 09EINC3540, 09EINC3567, 09EINC3566, 09EINC3560, 09EINC3592, 09EINC3655, 09EINC3648, 09EINC3681, 09EINC3715, 09EINC3767, 09EINC3752, 09EINC3824, 09EINC3810, 09EINC3849, 09EINC3870, 09EINC3853, 09EINC3866, 09EINC3869, 09EINC3899, 09EINC3877, 09EINC3915, 09EINC3907, 09EINC3929, 09EINC3942, 09EINC3955, 09EINC3969, 09EINC3961, 09EINC3965, 09EINC4033, 09EINC4056, 09EINC4046, 09EINC4091, 09EINC4093, 09EINC4085, 09EINC4090, 09EINC4096, 09EINC4107, 09EINC4120, 09EINC3950, 09EINC3329, 09EINC3475, 09EINC3695, 09EINC3759, 09EINC3927, 09EINC3165, 09EINC4009, 09EINC4104, 09EINC4024, 09EINC4121, 09EINC4140, 09EINC4156, 09EINC4163, 09EINC4176, 09EINC4219, 09EINC4265, 09EINC4288, 09EINC4309, 09EINC4303, 09EINC4374, 09EINC4380, 09EINC4376, 09EINC4367, 09EINC4361, 09EINC4377, 09EINC4410, 09EINC4418, 09EINC4389, 09EINC4411, 09EINC4436, 09EINC4441, 09EINC4452, 09EINC4464, 09EINC4455, 09EINC4477, 09EINC4484, 09EINC4472, 09EINC4470, 09EINC4501, 09EINC4529, 09EINC4562, 09EINC3959, 09EINC4554, 09EINC4599, 09EINC4620, 09EINC4630, 09EINC4672, 09EINC4658, 09EINC4670, 09EINC4661, 09EINC4662, 09EINC4679, 09EINC4688, 09EINC4707, 09EINC4691, 09EINC4726, 09EINC4737, 09EINC4757, 09EINC4759, 09EINC4767, 09EINC4803, 09EINC4839, 09EINC4845, 09EINC4822, 09EINC4847, 09EINC4882, 09EINC4919, 09EINC4940, 09EINC4948, 09EINC4952, 09EINC4957, 09EINC4987, 09EINC5000, 09EINC5014, 09EINC4437, 09EINC4976, 09EINC4998, 09EINC5038, 09EINC5030, 09EINC5021, 09EINC5065, 09EINC5047, 09EINC5067, 09EINC5082, 09EINC5076, 09EINC5096, 09EINC5086, 09EINC5107, 09EINC5101, 09EINC5137, 09EINC5151, 09EINC5170, 09EINC5172, 09EINC5186, 09EINC5162, 09EINC5194, 09EINC5200, 09EINC5222, 09EINC5227, 09EINC5240, 09EINC5273, 09EINC5248, 09EINC5276, 09EINC5284, 09EINC5286, 09EINC5288, 09EINC5300, 09EINC5316, 09EINC5309, 09EINC5317, 09EINC5330, 09EINC5357, 09EINC5359, 09EINC5348, 09EINC5369, 09EINC5370, 09EINC5378, 09EINC5376, 09EINC5415, 09EINC5445, 09EINC5434, 09EINC5456, 09EINC5446, 09EINC5502, 09EINC5504, 09EINC5521, 09EINC5515, 09EINC5562, 09EINC5596, 09EINC5576, 09EINC5580, 09EINC5615, 09EINC5600, 09EINC5652, 09EINC5643, 09EINC5636, 09EINC5645, 09EINC5711, 09EINC5720, 09EINC5714, 09EINC5699, 09EINC5718, 09EINC5747, 09EINC5759, 09EINC5767, 09EINC5771, 09EINC5746, 09EINC5774, 09EINC5805, 09EINC5796, 09EINC5791, 09EINC5839, 09EINC5883, 09EINC5898, 09EINC5887, 09EINC5910, 09EINC5903, 09EINC5936, 09EINC5919, 09EINC5927, 09EINC5925, 09EINC5966, 09EINC5979, 09EINC5972, 09EINC5969, 09EINC6047, 09EINC6036, 09EINC6027, 09EINC6013, 09EINC6019, 09EINC6054, 09EINC6061, 09EINC4097, 09EINC5177, 09EINC5930, 09EINC6077, 09EINC6104, 09EINC6108, 09EINC6154, 09EINC6181, 09EINC6173, 09EINC6171, 09EINC6169, 09EINC6207, 09EINC6203, 09EINC6252, 09EINC6275, 09EINC6260, 09EINC6304, 09EINC6310, 09EINC6322, 09EINC6317, 09EINC6344, 09EINC6326, 09EINC6357, 09EINC6351, 09EINC6367, 09EINC6366, 09EINC6380, 09EINC6406, 09EINC6403, 09EINC6419, 09EINC6418, 09EINC6433, 09EINC6486, 09EINC6476, 09EINC6488, 09EINC6505, 09EINC6508, 09EINC6516, 09EINC6525, 09EINC6529, 09EINC6558, 09EINC6559, 09EINC6577, 09EINC6588, 09EINC6628, 09EINC6611, 09EINC6610, 09EINC6620, 09EINC6635, 09EINC6633, 09EINC6662, 09EINC6688, 09EINC6706, 09EINC6733, 09EINC6695, 09EINC6752, 09EINC6349, 09EINC6379, 09EINC6756, 09EINC6833, 09EINC6867, 09EINC6873, 09EINC6928, 09EINC6941, 09EINC6923, 09EINC6959, 09EINC6955, 09EINC6965, 09EINC6411, 09EINC6593, 09EINC6726, 09EINC6843, 09EINC7001, 09EINC7012, 09EINC7021, 09EINC7019, 09EINC7025, 09EINC7010, 09EINC7039, 09EINC7046, 09EINC7043, 09EINC7075, 09EINC7093, 09EINC7077, 09EINC7104, 09EINC7117, 09EINC7098, 09EINC7113, 09EINC7116, 09EINC7118, 09EINC7138, 09EINC7148, 09EINC7141, 09EINC7163, 09EINC7200, 09EINC7203, 09EINC7199, 09EINC7218, 09EINC7233, 09EINC7225, 09EINC7235, 09EINC7245, 09EINC7296, 09EINC7356, 09EINC7342, 09EINC7339, 09EINC7394, 09EINC7416, 09EINC7405, 09EINC6933, 09EINC7444, 09EINC7447, 09EINC7458, 09EINC7475, 09EINC7488, 09EINC7472, 09EINC7503, 09EINC7512, 09EINC7547, 09EINC7541, 09EINC7573, 09EINC7606, 09EINC7598, 09EINC7604, 09EINC7591, 09EINC7667, 09EINC7678, 09EINC7659, 09EINC7692, 09EINC7684, 09EINC7697, 09EINC7738, 09EINC7724, 09EINC7722, 09EINC7755, 09EINC7770, 09EINC7757, 09EINC7763, 09EINC7782, 09EINC7781, 09EINC7772, 09EINC7803, 09EINC7845, 09EINC7842, 09EINC7864, 09EINC7895, 09EINC7903, 09EINC7886, 09EINC7896, 09EINC7955, 09EINC7973, 09EINC7964, 09EINC8001, 09EINC8000, 09EINC7994, 09EINC8004, 09EINC8007, 09EINC8013, 09EINC8041, 09EINC8131, 09EINC8116, 09EINC8109, 09EINC8170, 09EINC8155, 09EINC8174, 09EINC8215, 09EINC8217, 09EINC8247, 09EINC8223, 09EINC8273, 09EINC8309, 09EINC8274, 09EINA8046, 09EINA8277, 09EINA8278, 09EINA8297, 09EINA8681, 09EINA8686, 09EINA8541, 09EINA8703, 09EINA8707, 09EINA8722, 09EINA8736, 09EINA8742, 09EINA8752, 09EINA8732, 09EINA8739, 09EINA8738, 09EINA8749, 09EINA8741, 09EINA8792, 09EINA8757, 09EINA8774, 09EINA8780, 09EINA8811, 09EINA8810, 09EINA8830, 09EINA8885, 09EINA8886, 09EINA8905, 09EINA8910, 09EINA8916, 09EINA8956, 09EINA8923, 09EINA8979, 09EINA8963, 09EINA8991, 09EINA9018, 09EINA8986, 09EINA9007, 09EINA9017, 09EINA9049, 09EINA9047, 09EINA9057, 09EINA9117, 09EINA9122, 09EINA9127, 09EINA9104, 09EINA9108, 09EINA9099, 09EINA9115, 09EINA9130, 09EINA8827, 09EINA8888, 09EINA9033, 09EINA9145, 09EINA9159, 09EINA9165, 09EINA9239, 09EINA9242, 09EINA9238, 09EINA9274, 09EINA9269, 09EINA9280, 09EINA9293, 09EINA9340, 09EINA9317, 09EINA9330, 09EINA9309, 09EINA9343, 09EINA9375, 09EINA9381, 09EINA9368, 09EINA9373, 09EINA9384, 09EINA9403, 09EINA9435, 09EINA9416, 09EINA9457, 09EINA8371, 09EINA9232, 09EINA9408, 09EINA9526, 09EINA9575, 09EINA9543, 09EINA9552, 09EINA9551, 09EINA9587, 09EINA9626, 09EINA9629, 09EINA9624, 09EINA9628, 09EINA9664, 09EINA9666, 09EINA9681, 09EINA9670, 09EINA9720, 09EINA9724, 09EINA9712, 09EINA9701, 09EINA9770, 09EINA9777, 09EINA9779, 09EINA9839, 09EINA9826, 09EINA9834, 09EINA9846, 09EINA9853, 09EINA9850, 09EINA9867, 09EINA9930, 09EINA9944, 09EINA9926, 09EINA9965, 09EINA9964, 09EINA9960, 09EINA9974, 09EINA9962, 09EINA9956, 09EINB0009, 09EINB0028, 09EINB0025, 09EINB0032, 09EINB0078, 09EINB0081, 09EINB0093, 09EINB0149, 09EINB0134, 09EINB0190, 09EINB0185, 09EINB0170, 09EINA7514, 09EINA9001, 09EINA9616, 09EINA9734, 09EINB0077, 09EINB0214, 09EINB0229, 09EINB0218, 09EINB0188, 09EINB0224, 09EINB0235, 09EINB0247, 09EINB0288, 09EINB0267, 09EINB0263, 09EINB0282, 09EINB0262, 09EINB0302, 09EINB0359, 09EINB0385, 09EINB0387, 09EINB0386, 09EINB0404, 09EINB0408, 09EINB0407, 09EINB0413, 09EINB0406, 09EINB0453, 09EINB0437, 09EINB0430, 09EINB0448, 09EINB0486, 09EINB0514, 09EINB0527, 09EINB0553, 09EINB0598, 09EINB0614, 09EINB0610, 09EINB0613, 09EINB0605, 09EINB0616, 09EINB0644, 09EINB0618, 09EINB0621, 09EINB0652, 09EINA0832, 09EINB0679, 09EINB0694, 09EINA4567, 09EINB0065, 09EINB0721, 09EINB0724, 09EINB0702, 09EINB0745, 09EINB0764, 09EINB0736, 09EINB0824, 09EINB0856, 09EINB0845, 09EINB0829, 09EINB0874, 09EINB0889, 09EINB0905, 09EINB0988, 09EINB0981, 09EINB1004, 09EINB1006, 09EINB1008, 09EINB1020, 09EINB0532, 09EINB0827, 09EINB1033, 09EINB1073, 09EINB1076, 09EINB1112, 09EINB1135, 09EINB1155, 09EINB1161, 09EINB1170, 09EINB1154, 09EINB1175, 09EINB1206, 09EINB1251, 09EINB1285, 09EINB1296, 09EINB0066, 09EINB0630, 09EINB0954, 09EINB1308, 09EINB1307, 09EINB1186, 09EINB1268, 09EINB1067, 09EINB1299, 09EINB1313, 09EINB1332, 09EINB1329, 09EINB1339, 09EINB1340, 09EINB1358, 09EINB1376, 09EINB1381, 09EINB1409, 09EINB1477, 09EINB1511, 09EINB1505, 09EINB1508, 09EINB1500, 09EINB1541, 09EINB1522, 09EINB1566, 09EINB1554, 09EINB1583, 09EINB1582, 09EINB1594, 09EINB1611, 09EINB1643, 09EINB1650, 09EINB1687, 09EINB1697, 09EINB1739, 09EINB1751, 09EINB1740, 09EINB1728, 09EINB1746, 09EINB1743, 09EINB1745, 09EINB1771, 09EINB1777, 09EINB1823, 09EINB1824, 09EINB1816, 09EINB1846, 09EINB1836, 09EINB1880, 09EINB1902, 09EINB1898, 09EINB1973, 09EINB1939, 09EINB1991, 09EINB1976, 09EINB1984, 09EINB1223, 09EINB1844, 09EINB1891, 09EINB2021, 09EINB2029, 09EINB2063, 09EINB2060, 09EINB2111, 09EINB2152, 09EINB2177, 09EINB2189, 09EINB2204, 09EINB2215, 09EINB2227, 09EINB2239, 09EINB2242, 09EINB2266, 09EINB2283, 09EINB2312, 09EINB2325, 09EINB2319, 09EINB2336, 09EINB2340, 09EINB2341, 09EINB2369, 09EINB2379, 09EINB2421, 09EINB2434, 09EINB2439, 09EINB2479, 09EINB2506, 09EINB2503, 09EINB2517, 09EINB2548, 09EINB2537, 09EINB2532, 09EINB2544, 09EINB2559, 09EINB2574, 09EINB2622, 09EINB2667, 09EINB2670, 09EINB2655, 09EINB2691, 09EINB2713, 09EINB2709, 09EINB2767, 09EINB2748, 09EINB2756, 09EINB2777, 09EINB2801, 09EINB2852, 09EINB2901, 09EINB2910, 09EINB2948, 09EINB2961, 09EINB3016, 09EINB2993, 09EINB3013, 09EINB3008, 09EINB2997, 09EINB3023, 09EINB1343, 09EINB2509, 09EINB2611, 09EINB3051, 09EINB2953, 09EINB3053, 09EINB3061, 09EINB3084, 09EINB3097, 09EINB3129, 09EINB3134, 09EINB3139, 09EINB3137, 09EINB3154, 09EINB3145, 09EINB3153, 09EINB3164, 09EINB3158, 09EINB3196, 09EINB3249, 09EINB3251, 09EINB3278, 09EINB3319, 09EINB3318, 09EINB3286, 09EINB3332, 09EINB3359, 09EINB3362, 09EINB3391, 09EINB3426, 09EINB3442, 09EINB3468, 09EINB3473, 09EINB3519, 09EINB3355, 09EINB3159, 09EINB1812, 09EINB3184, 09EINB3271, 09EINB3433, 09EINB3448, 09EINB3529, 09EINB3578, 09EINB3566, 09EINB3569, 09EINB3619, 09EINB3632, 09EINB3640, 09EINB3645, 09EINB3643, 09EINB3660, 09EINB3669, 09EINB3650, 09EINB3668, 09EINB3701, 09EINB3688, 09EINB3699, 09EINB3749, 09EINB3719, 09EINB3747, 09EINB3729, 09EINB3734, 09EINB3768, 09EINB3777, 09EINB3862, 09EINB3885, 09EINB3889, 09EINB3890, 09EINB3898, 09EINB3933, 09EINB3917, 09EINB3913, 09EINB3923, 09EINB3924, 09EINB3967, 09EINB3957, 09EINB4006, 09EINB4004, 09EINB4067, 09EINB4071, 09EINB4093, 09EINB4098, 09EINB4109, 09EINB4134, 09EINB4137, 09EINB4133, 09EINB4147, 09EINB4174, 09EINB4179, 09EINB4165, 09EINB4183, 09EINB1041, 09EINB3540, 09EINB3856, 09EINB4184, 09EINB4240, 09EINB4233, 09EINB4287, 09EINB4302, 09EINB4297, 09EINB4296, 09EINB4307, 09EINB4321, 09EINB4326, 09EINB4360, 09EINB4341, 09EINB4402, 09EINB4432, 09EINB4423, 09EINB4447, 09EINB4496, 09EINB4502, 09EINB4533, 09EINB4545, 09EINB4546, 09EINB4530, 09EINB4531, 09EINB4536, 09EINB4576, 09EINB4619, 09EINB4603, 09EINB4629, 09EINB4656, 09EINB4646, 09EINB4718, 09EINB4701, 09EINB4700, 09EINB4759, 09EINB4744, 09EINB4788, 09EINB4795, 09EINB4804, 09EINB4819, 09EINB4796, 09EINB4817, 09EINB4800, 09EINB4836, 09EINB4858, 09EINB4841, 09EINB4850, 09EINB4867, 09EINB4881, 09EINB4878, 09EINB4918, 09EINB4931, 09EINB4953, 09EINB4923, 09EINB4951, 09EINB4962, 09EINB4959, 09EINB5015, 09EINB5022, 09EINB5026, 09EINB5059, 09EINB5054, 09EINB5139, 09EINB5125, 09EINB5182, 09EINB5231, 09EINB5234, 09EINB5206, 09EINB5251, 09EINB5243, 09EINB5252, 09EINB5287, 09EINB5277, 09EINB5293, 09EINB5275, 09EINB5299, 09EINB5331, 09EINB5315, 09EINB5316, 09EINB5343, 09EINB4803, 09EINB4897, 09EINB4939, 09EINB5272, 09EINB5327, 09EINB5398, 09EINB5390, 09EINB5375, 09EINB5421, 09EINB5453, 09EINB5425, 09EINB5424, 09EINB5465, 09EINB5474, 09EINB5467, 09EINB5479, 09EINB5480, 09EINB5481, 09EINB5507, 09EINB5504, 09EINB5499, 09EINB5494, 09EINB5537, 09EINB5554, 09EINB1445, 09EINB5602, 09EINB5615, 09EINB5627, 09EINB5647, 09EINB5666, 09EINB5672, 09EINB5670, 09EINB5713, 09EINB5729, 09EINB5707, 09EINB5738, 09EINB5768, 09EINB5799, 09EINB5793, 09EINB5782, 09EINB5842, 09EINB5819, 09EINB5858, 09EINB5895, 09EINB5663, 09EINB5430, 09EINB5700, 09EINB5948, 09EINB5942, 09EINB5937, 09EINB5979, 09EINB5953, 09EINB5961, 09EINB5960, 09EINB5993, 09EINB5984, 09EINB6010, 09EINB6031, 09EINB6027, 09EINB6043, 09EINB6077, 09EINB6086, 09EINB6081, 09EINB6085, 09EINB6073, 09EINB6114, 09EINB6104, 09EINB6127, 09EINB6132, 09EINB6124, 09EINB6138, 09EINB6142, 09EINB6168, 09EINB6184, 09EINB6193, 09EINB6208, 09EINB6249, 09EINB6254, 09EINB6238, 09EINB6288, 09EINB6319, 09EINB6341, 09EINB6353, 09EINB6362, 09EINB6384, 09EINB6381, 09EINB6397, 09EINB6388, 09EINB6430, 09EINB6451, 09EINB6481, 09EINB6506, 09EINB6482, 09EINB6508, 09EINB6525, 09EINB6529, 09EINB6584, 09EINB6615, 09EINB6645, 09EINB6689, 09EINB6668, 09EINB6679, 09EINB6685, 09EINB6735, 09EINB6712, 09EINB6741, 09EINB6740, 09EINB6768, 09EINB6753, 09EINB6822, 09EINB6825, 09EINB6831, 09EINB6858, 09EINB3372, 09EINB6243, 09EINB5677, 09EINB6089, 09EINB6587, 09EINB6662, 09EINB6791, 09EINB6604, 09EINB6879, 09EINB6869, 09EINB6877, 09EINB6885, 09EINB6895, 09EINB6923, 09EINB6984, 09EINB7060, 09EINB7050, 09EINB7058, 09EINB7065, 09EINB1858, 09EINB6908, 09EINB6839, 09EINB6444, 09EINB6993, 09EINB7093, 09EINB7019, 09EINB7115, 09EINB7111, 09EINB7097, 09EINB7098, 09EINB7164, 09EINB7163, 09EINB7178, 09EINB7189, 09EINB7197, 09EINB7222, 09EINB7268, 09EINB7281, 09EINB7278, 09EINB7273, 09EINB7276, 09EINB5483, 09EINB5971, 09EINB6725, 09EINB6938, 09EINB6968, 09EINB7347, 09EINB7343, 09EINB7325, 09EINC8327, 09EINC7650, 09EINC7879, 09EINC8126, 09EINC8357, 09EINC8368, 09EINC8377, 09EINC8370, 09EINC8420, 09EINC8422, 09EINC8425, 09EINC8411, 09EINC2732, 09EINC3644, 09EINC8479, 09EINC8475, 09EINC8488, 09EINC8494, 09EINC8506, 09EINC8525, 09EINC8538, 09EINC8571, 09EINC8585, 09EINC8634, 09EINC8660, 09EINC8645, 09EINC8639, 09EINC8644, 09EINC8710, 09EINC8752, 09EINC8742, 09EINC8753, 09EINC8769, 09EINC8764, 09EINC8760, 09EINC8773, 09EINC8792, 09EINC8793, 09EINC8825, 09EINC8839, 09EINC8854, 09EINC8852, 09EINC8885, 09EINC8934, 09EINC8951, 09EINC8966, 09EINC8982, 09EINC8985, 09EINC9012, 09EINC9082, 09EINC9120, 09EINC9125, 09EINC9116, 09EINC9187, 09EINC9185, 09EINC9176, 09EINC9196, 09EINC9195, 09EINC8028, 09EINC9234, 09EINC9257, 09EINC9295, 09EINC9299, 09EINC9278, 09EINC9319, 09EINC9308, 09EINC9309, 09EINC9318, 09EINC9313, 09EINC9348, 09EINC9370, 09EINC9377, 09EINC9401, 09EINC9402, 09EINC9405, 09EINC9414, 09EINC9443, 09EINC9423, 09EINC9442, 09EINC9462, 09EINC9487, 09EINC9484, 09EINC9502, 09EINC9498, 09EINC9555, 09EINC9545, 09EINC9548, 09EINC9572, 09EINC9596, 09EINC9639, 09EINC9624, 09EINC9635, 09EINC9640, 09EINC9650, 09EINC9686, 09EINC9721, 09EINC9706, 09EINC9735, 09EINC9742, 09EINC9758, 09EINC9793, 09EINC9800, 09EINC9789, 09EINC9807, 09EINC9848, 09EINC9849, 09EINC9827, 09EINC9871, 09EINC9865, 09EINC9881, 09EINC9912, 09EINC9915, 09EINC9910, 09EINC9923, 09EINC9943, 09EINC9970, 09EINC9979, 09EINC9958, 09EINC9991, 09EIND0022, 09EIND0045, 09EIND0049, 09EIND0046, 09EIND0115, 09EIND0102, 09EIND0101, 09EIND0147, 09EIND0129, 09EIND0122, 09EIND0138, 09EIND0175, 09EIND0157, 09EIND0176, 09EIND0203, 09EIND0200, 09EIND0196, 09EIND0181, 09EIND0209, 09EIND0235, 09EIND0252, 09EIND0275, 09EIND0264, 09EIND0255, 09EIND0297, 09EIND0299, 09EIND0305, 09EINC9531, 09EINC9695, 09EIND0082, 09EIND0345, 09EIND0359, 09EIND0352, 09EIND0288, 09EIND0374, 09EIND0392, 09EIND0433, 09EIND0467, 09EIND0497, 09EIND0496, 09EIND0507, 09EIND0554, 09EIND0561, 09EIND0563, 09EIND0568, 09EIND0621, 09EIND0623, 09EIND0620, 09EINC9016, 09EINC9607, 09EIND0365, 09EIND0628, 09EIND0629, 09EIND0631, 09EIND0400, 09EIND0696, 09EIND0684, 09EIND0733, 09EIND0791, 09EIND0784, 09EIND0788, 09EIND0786, 09EIND0816, 09EIND0843, 09EIND0846, 09EIND0863, 09EIND0888, 09EIND0890, 09EIND0902, 09EIND0896, 09EIND0923, 09EIND0911, 09EIND0940, 09EIND0920, 09EIND0924, 09EIND0938, 09EIND0966, 09EIND0960, 09EIND0942, 09EIND0957, 09EIND0981, 09EIND0996, 09EIND0972, 09EIND1013, 09EIND1004, 09EIND1018, 09EIND1074, 09EIND1052, 09EIND1054, 09EIND1090, 09EIND1093, 09EIND1102, 09EINC9673, 09EIND0274, 09EIND1126, 09EIND1136, 09EIND1151, 09EIND1160, 09EIND1198, 09EIND1197, 09EIND1249, 09EIND1263, 09EIND1254, 09EIND1247, 09EIND1268, 09EIND1296, 09EIND1292, 09EIND1311, 09EIND1331, 09EIND1329, 09EIND1357, 09EIND1419, 09EIND1418, 09EIND1445, 09EIND1457, 09EIND1470, 09EIND1484, 09EIND1551, 09EIND1521, 09EIND1533, 09EIND1525, 09EIND1522, 09EIND1568, 09EIND1578, 09EIND1581, 09EIND1572, 09EIND1592, 09EIND1605, 09EIND1654, 09EIND1646, 09EIND1671, 09EIND1711, 09EIND1743, 09EIND1726, 09EIND1755, 09EIND1764, 09EIND1791, 09EINC4066, 09EIND0263, 09EIND1626, 09EIND1461, 09EIND1845, 09EIND1850, 09EIND1894, 09EIND1920, 09EIND1923, 09EIND1957, 09EIND1954, 09EIND1987, 09EIND1983, 09EIND2015, 09EIND2025, 09EIND2019, 09EINC1144, 09EINC3842, 09EINC3776, 09EINC2559, 09EINC2566, 09EIND2051, 09EIND2069, 09EIND2058, 09EIND2121, 09EIND2133, 09EIND2142, 09EIND2154, 09EINF6914, 09EINF7604, 09EINF7615, 09EINF6800, 09EINF6905, 10EINA1446, 09EINF6990, 09EINF6873, 09EINF6882, 09EINF6940, 09EINF6932, 10EINA1448, 10EINA1470, 10EINA1356, 10EINA1392, 10EINA1400, 10EINA1405, 10EINA1328, 09EINF7028, 09EINF7042, 09EINF7258, 09EINF7002, 09EINF7185, 09EINF7180, 09EINF7174, 09EINF7225, 09EINF7228, 09EINF7056, 09EINF7153, 09EINF7128, 09EINF7120, 09EINF7139, 09EINF7296, 09EINF6819, 09EINF6655, 09EINF6646, 09EINF6828, 09EINF6753, 10EINA1134, 09EINF6638, 09EINF6623, 10EINA0649, 09EINF6968, 10EINA1501, 10EINA0347, 10EINA1768, 09EINF7280, 09EINF7297, 09EINF7264, 09EINF6949, 09EINF6944, 09EINF6788, 10EINA1562, 10EINA1567, 10EINA0094, 10EINA0455, 10EINA0433, 10EINA0421, 10EINA0388, 10EINA1540, 10EINA0499, 10EINA0492, 10EINA0287, 10EINA0027, 10EINA0019, 09EINF7661, 09EINF7648, 09EINF7640, 09EINF7628, 10EINA0129, 10EINA0243, 10EINA0256, 10EINA0249, 10EINA0248, 10EINA0255, 10EINA0171, 10EINA0159, 10EINA0172, 10EINA0193, 10EINA0191, 10EINA0114, 09EINF7583, 09EINF7524, 10EINA1314, 09EINF7511, 10EINA1309, 09EINF7422, 09EINF7402, 09EINF7400, 09EINF7395, 09EINF7388, 10EINA0834, 10EINA1230, 10EINA1214, 10EINA1254, 10EINA1866, 10EINA1870, 10EINA1828, 10EINA1688, 10EINA1057, 10EINA1068, 10EINA1080, 10EINA0888, 10EINA0934, 10EINA0932, 10EINA0945, 10EINA1111, 10EINA1112, 10EINA1040, 10EINA0653, 10EINA1722, 10EINA0700, 10EINA0699, 10EINA0606, 10EINA0613, 10EINA0562, 10EINA0550, 10EINA0555, 10EINA0511, 10EINA1130, 10EINA1700, 10EINA1692, 10EINA1690, 10EINA0973, 10EINA0974, 10EINA1136, 10EINA2585, 10EINA2580, 10EINA2295, 10EINA2823, 10EINA2816, 10EINA2866, 10EINA2796, 10EINA2844, 10EINA0811, 10EINA0824, 10EINA0809, 10EINA0800, 10EINA0757, 10EINA0743, 10EINA1729, 10EINA0708, 10EINA0670, 10EINA2513, 10EINA2504, 10EINA2493, 10EINA2473, 10EINA2480, 10EINA2640, 10EINA2766, 10EINA2629, 10EINA2676, 10EINA2649, 10EINA2141, 10EINA2013, 10EINA2257, 10EINA2248, 10EINA2285, 10EINA2305, 10EINA2424, 10EINA2400, 10EINA2402, 10EINA2533, 10EINA2525, 10EINA2009, 10EINA2018, 10EINA2112, 10EINA1974, 10EINA1976, 10EINA1958, 10EINA2040, 10EINA1952, 10EINA2045, 10EINA2080, 10EINA2088, 10EINA2073, 10EINA2069, 10EINA2104, 10EINA2222, 10EINA2228, 10EINA3119, 10EINA3054, 10EINA3090, 10EINA3092, 10EINA3073, 10EINA2966, 10EINA2943, 10EINA2934, 10EINA3258, 10EINA3261, 10EINA3270, 10EINA3423, 10EINA3234, 10EINA3202, 10EINA3201, 10EINA3322, 10EINA3149, 10EINA3168, 10EINA3300, 10EINA3662, 10EINA3630, 10EINA3589, 10EINA3554, 10EINA3459, 10EINA3447, 10EINA3438, 10EINA3429, 10EINA3356, 10EINA3490, 10EINA4726, 10EINA4793, 10EINA3694, 10EINA3847, 10EINA3682, 10EINA3869, 10EINA3866, 10EINA4462, 10EINA4583, 10EINA4628, 10EINA4600, 10EINA4440, 10EINA3923, 10EINA4114, 10EINA4280, 10EINA4658, 10EINA4654, 10EINA4847, 10EINA4835, 10EINA4734, 10EINA4165, 10EINA4166, 10EINA4277, 10EINA4297, 10EINA4210, 10EINA4125, 10EINA4322, 10EINA4321, 10EINA4470, 10EINA4483, 10EINA4480, 10EINA4379, 10EINA4356, 10EINA4360, 10EINA3956, 10EINA3890, 10EINA3906, 10EINA3928, 10EINA4047, 10EINA4045, 10EINA4022, 10EINA3997, 10EINA3983, 10EINA3990, 10EINA3995, 10EINA3986, 10EINA4256, 10EINA5569, 10EINA5431, 10EINA5438, 10EINA5489, 10EINA5422, 10EINA5424, 10EINA5639, 10EINA5831, 10EINA5793, 10EINA5733, 10EINA3776, 10EINA5324, 10EINA5283, 10EINA5274, 10EINA5352, 10EINA5261, 10EINA5619, 10EINA5597, 10EINA5523, 10EINA4955, 10EINA4870, 10EINA4871, 10EINA5036, 10EINA5031, 10EINA5052, 10EINA5189, 10EINA5146, 10EINA2984, 10EINA4393, 10EINA5129, 10EINA5079, 10EINA5067, 10EINA6043, 10EINA5707, 10EINA5660, 10EINA5650, 10EINA5648, 10EINA5945, 10EINA4685, 10EINA4883, 10EINA4930, 10EINA4915, 10EINA4982, 10EINA6346, 10EINA5971, 10EINA6284, 10EINA6083, 10EINA6077, 10EINA6096, 10EINA5997, 10EINA5871, 10EINA5878, 10EINA5885, 10EINA5882, 10EINA5917, 10EINA6431, 10EINA6430, 10EINA6460, 10EINA6463, 10EINA6484, 10EINA6515, 10EINA6536, 10EINA6409, 10EINA6615, 10EINA6550, 10EINA6569, 10EINA6575, 10EINA6373, 10EINA6393, 10EINA6392, 10EINA6391, 10EINA3476, 10EINA5909, 10EINA5767, 10EINA5832, 10EINA6076, 10EINA6151, 10EINA6302, 10EINA6269, 10EINA6222, 10EINA6215, 10EINA6228, 10EINA6243, 10EINA6261, 10EINA7157, 10EINA7153, 10EINA6862, 10EINA7536, 10EINA7076, 10EINA7121, 10EINA7168, 10EINA7170, 10EINA7166, 10EINA6898, 10EINA6641, 10EINA7222, 10EINA7285, 10EINA7000, 10EINA7003, 10EINA7018, 10EINA7038, 10EINA8128, 10EINA8139, 10EINA8276, 10EINA8285, 10EINA6661, 10EINA6664, 10EINA6649, 10EINA6685, 10EINA6748, 10EINA6704, 10EINA6733, 10EINA7329, 10EINA7366, 10EINA7334, 10EINA7952, 10EINA7949, 10EINA7853, 10EINA7852, 10EINA7858, 10EINA7928, 10EINA7935, 10EINA7875, 10EINA7881, 10EINA7830, 10EINA7957, 10EINA8004, 10EINA8067, 10EINA8076, 10EINA7979, 10EINA7459, 10EINA8172, 10EINA8161, 10EINA7557, 10EINA7429, 10EINA7033, 10EINA7475, 10EINA7584, 10EINA7676, 10EINA7697, 10EINA7772, 10EINA7663, 10EINA7667, 10EINA7803, 10EINA7811, 10EINA7735, 10EINA7818, 10EINA8331, 10EINA8347, 10EINA8351, 10EINA8365, 10EINA8273, 10EINA8255, 10EINA8241, 10EINA7544, 10EINA7545, 10EINA8205, 10EINA8312, 10EINA8305, 10EINA8847, 10EINA8875, 10EINA8914, 10EINA8905, 10EINA8921, 10EINA8955, 10EINA8669, 10EINA8866, 10EINA8869, 10EINA9141, 10EINA9187, 10EINA9111, 10EINA8418, 10EINA8420, 10EINA8982, 10EINA8971, 10EINA1665, 10EINA8526, 10EINA8841, 10EINA8707, 10EINA8711, 10EINA8583, 10EINA8680, 10EINA8679, 10EINA8821, 10EINA8629, 10EINA9355, 10EINA8576, 10EINA8481, 10EINA8493, 10EINA8550, 10EINA8988, 10EINA8999, 10EINA8934, 10EINA9082, 10EINA9066, 10EINA9081, 10EINA9047, 10EINA9024, 10EINA9374, 10EINA9260, 10EINA9248, 10EINA9235, 10EINA9313, 10EINA9325, 10EINA9337, 10EINA9491, 10EINA9552, 10EINA9572, 10EINA9571, 10EINA9580, 10EINA9594, 10EINA9589, 10EINA9604, 10EINA9718, 10EINA9614, 10EINA9610, 10EINA9435, 10EINA9653, 10EINA9673, 10EINA9693, 10EINA9709, 10EINB0160, 10EINB0161, 10EINB0151, 10EINA9914, 10EINA9882, 10EINA9870, 10EINA9948, 10EINA9799, 10EINA4650, 10EINA9763, 10EINB0269, 10EINB0392, 10EINB0391, 10EINB0085, 10EINB0198, 10EINB0201, 10EINB0121, 10EINB0071, 10EINB0045, 10EINB0167, 10EINB0165, 10EINB0039, 10EINB0697, 10EINB0441, 10EINA8896, 10EINB0525, 10EINB0645, 10EINB0536, 10EINB0497, 10EINB0478, 10EINB0596, 10EINB0613, 10EINB0230, 10EINB1014, 10EINB1003, 10EINB0997, 10EINB0740, 10EINB0721, 10EINB0716, 10EINB0885, 10EINB0881, 10EINB0862, 10EINB0806, 10EINB0811, 10EINB1122, 10EINB1114, 10EINB1520, 10EINB1186, 10EINB1307, 10EINB1248, 10EINB1259, 10EINB0901, 10EINB0913, 10EINB1354, 10EINB1348, 10EINB1481, 10EINB1447, 10EINB1457, 10EINB1868, 10EINB1874, 10EINB1923, 10EINB1941, 10EINB1808, 10EINB1593, 10EINB1580, 10EINB1846, 10EINB1500, 10EINB1379, 10EINB1675, 10EINB1798, 10EINB1713, 10EINB1749, 10EINA8975, 10EINB2113, 10EINB2162, 10EINB2224, 10EINB2196, 10EINB2297, 10EINB2141, 10EINB2047, 10EINB2182, 10EINB2188, 10EINB2499, 10EINB2321, 10EINB2317, 10EINB2460, 10EINB2426, 10EINB2282, 10EINB2443, 10EINB3141, 10EINB3151, 10EINB3030, 10EINB3115, 10EINB3054, 10EINB3002, 10EINB3106, 10EINB2672, 10EINB2591, 10EINB2616, 10EINB2599, 10EINB2843, 10EINB2766, 10EINB3129, 10EINB2789, 10EINB3210, 10EINB2829, 10EINB2748, 10EINB2750, 10EINB2902, 10EINB3194, 10EINB2631, 10EINB2531, 10EINB2583, 10EINB2717, 10EINB2962, 10EINB3470, 10EINB3468, 10EINB3544, 10EINB3484, 10EINB3492, 10EINB3349, 09EINA3873, 09EINB3199, 09EINB4068, 09EINB4320, 09EINB3737, 09EINA1709, 09EINB0698, 09EINB0182, 09EINB1444, 09EINB1920, 09EINA9728, 09EINA9732, 09EINA8875, 09EINB1244, 09EINA5085, 09EINA5019, 09EINA3816, 09EINA2765, 09EINA4697, 09EINA3960, 09EINA2462, 09EINA5179, 09EINA5484, 09EINA5216, 09EINA6040, 09EINA0318, 09EINA0439, 09EINA0645, 09EINA5669, 09EINA5856, 09EINA5741, 09EINC2065, 09EINC1408, 09EINC1617, 09EINC1969, 09EINC2300, 09EINC0570, 09EINC0894, 09EINC1202, 09EINB6423, 09EINB6783, 09EINC3956, 09EINC4459, 09EINC3407, 09EINC3857, 09EINC3791, 09EINC9553, 09EINC4903, 09EINC4649, 09EINC4756, 09EINB7510, 09EINC6332, 09EINC6243, 09EINC6484, 09EINB5288, 09EINB5321, 09EINC9105, 09EINC9272, 09EINB7021, 09EINB6996, 09EINB6153, 09EINC7513, 09EINC7871, 09EIND0689, 09EIND0705, 09EINB8693, 09EINB8666, 09EINC0172, 09EINE7676, 09EINE5419, 09EINE5493, 09EINE4452, 09EINE5896, 09EINF4088, 09EINE1873, 09EINE7080, 09EINE6918, 09EINE7517, 09EINE6506, 09EINE7167, 09EINE7464, 09EINE8804, 09EINE8732, 09EINF0648, 09EINF0423, 09EINE0006, 09EINE3738, 09EINE3412, 09EINE3458, 09EINE2644, 09EINE2782, 09EINE0131, 09EIND9391, 09EINF1172, 09EIND1007, 09EIND9656, 09EIND9682, 09EIND2435, 09EIND2462, 09EIND5270, 09EIND5130, 09EIND1614, 10EINA7882, 10EINA2720, 10EINA0885, 10EINA0855, 10EINA0279, 10EINA0846, 09EINF6614, 10EINA9721, 10EINA9757, 10EINA1145, 10EINB3755, 10EINB3834, 10EINB3691, 10EINB3872, 10EINB3676, 10EINB3660, 10EINB3787, 10EINC1559, 10EINB5717, 10EINB4964, 10EINB4393, 10EINB6312, 10EINB3982, 10EINB6871, 10EINB8056, 10EINB6603, 10EINB6368, 10EINB4383, 10EINB7027, 10EINC1384 Class II Blood products, collected from donors who did not have a complete physical examination, were distributed. BioLife Plasma Services L.P.
Biologics Source Plasma 09FMOE9547, 09FMOE9637, 09FMOE9704, 09FMOE9733, 09FMOE9974, 09FMOF0004, 09FMOF0088, 09FMOF0307, 09FMOF0324, 09FMOF0345, 09FMOF0361, 09FMOF0411, 09FMOF0418, 09FMOF0439, 09FMOF0475, 09FMOF0501, 09FMOF0549, 09FMOF0762, 09FMOF0893, 09FMOF0905, 09FMOF0926, 09FMOF0959, 09FMOF0984, 09FMOF1130, 09FMOF1158, 09FMOF1161, 09FMOF1168, 09FMOF1169, 09FMOF1269, 09FMOF1277, 09FMOF1317, 09FMOF1471, 09FMOF1479, 09FMOF1611, 09FMOF1633, 09FMOF1643, 09FMOF1651, 09FMOF1750, 09FMOF1847, 09FMOF1848, 09FMOF1970, 09FMOF2107, 09FMOF2121, 09FMOF2133, 09FMOF2183, 09FMOF2184, 09FMOF2213, 09FMOF2267, 09FMOF2336, 09FMOF2364, 09FMOF2365, 09FMOF2401, 09FMOF2405, 09FMOF2435, 09FMOF2449, 09FMOF2450, 09FMOF2553, 09FMOF2669, 09FMOF2697, 09FMOF2859, 09FMOF2892, 09FMOF2931, 09FMOF2942, 09FMOF2988, 09FMOF3007, 09FMOF3248, 09FMOF3344, 09FMOF3391, 09FMOF3400, 09FMOF3406, 09FMOF3429, 09FMOF3725, 09FMOF3922, 09FMOF3929, 09FMOF3937, 09FMOF3965, 09FMOF4043, 09FMOF4136, 09FMOF4145, 09FMOF4186, 09FMOF4227, 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10FMOF0433, 10FMOF0458, 10FMOF0459, 10FMOF0485, 10FMOF0594, 10FMOF0627, 10FMOF0747, 10FMOF0783, 10FMOF0794, 10FMOF0802, 10FMOF0807, 10FMOF0872, 10FMOF0932, 10FMOF0943, 10FMOF1085, 10FMOF1107, 10FMOF1157, 10FMOF1205, 10FMOF1314, 10FMOF1379, 10FMOF1485, 10FMOF1527, 10FMOF1554, 10FMOF1573, 10FMOF1628, 10FMOF1701, 10FMOF1712, 10FMOF1748, 10FMOF1807, 10FMOF1822, 10FMOF1866, 10FMOF1889, 10FMOF1926, 10FMOF2005, 10FMOF2099, 10FMOF2169, 10FMOF2198, 10FMOF2201, 10FMOF2223, 10FMOF2233, 10FMOF2347, 10FMOF2383, 10FMOF2404, 10FMOF2441, 10FMOF2455, 10FMOF2468, 10FMOF2470, 10FMOF2630, 10FMOF2650, 10FMOF2682, 10FMOF2833, 10FMOF2843, 10FMOF2869, 10FMOF2988, 10FMOF3041, 10FMOF3042, 10FMOF3080, 10FMOF3092, 10FMOF3117, 10FMOF3124, 10FMOF3187, 10FMOF3198, 10FMOF3241, 10FMOF3248, 10FMOF3262, 10FMOF3532, 10FMOF3618, 10FMOF3670, 10FMOF3685, 10FMOF3755, 10FMOF3787, 10FMOF3803, 10FMOF3839, 10FMOF4373, 10FMOF4421, 10FMOF4438, 10FMOF4451, 10FMOF4461, 10FMOF4520, 10FMOF4578, 10FMOF4601, 10FMOF4639, 10FMOF4659, 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11FMOA2526, 11FMOA2534, 11FMOA2573, 11FMOA2652, 11FMOA2752, 11FMOA2801, 11FMOA2961, 11FMOA3106, 11FMOA3130, 11FMOA3164, 11FMOA3325, 11FMOA3338, 11FMOA3349, 11FMOA3388, 11FMOA3612, 11FMOA3741, 11FMOA3816, 11FMOA3889, 11FMOA3926, 11FMOA3943, 11FMOA4042, 11FMOA4099, 11FMOA4346, 11FMOA4366, 11FMOA4397, 11FMOA4460, 11FMOA4495, 11FMOA4612, 11FMOA4641, 11FMOA4647, 11FMOA4679, 11FMOA4691, 11FMOA4731, 11FMOA4754, 11FMOA4773, 11FMOA4877, 11FMOA5020, 11FMOA5059, 11FMOA5139, 11FMOA5154, 11FMOA5209, 11FMOA5245, 11FMOA5347, 11FMOA5349, 11FMOA5372, 11FMOA5406, 11FMOA5457, 11FMOA5568, 11FMOA5604, 11FMOA5694, 11FMOA5720, 11FMOA5750, 11FMOA5933, 11FMOA5948, 11FMOA6016, 11FMOA6142, 11FMOA6148, 11FMOA6158, 11FMOA6185, 11FMOA6260, 11FMOA6395, 11FMOA6524, 11FMOA6560, 11FMOA6667, 11FMOA6804, 11FMOA6938, 11FMOA6942, 11FMOA6953, 11FMOA6994, 11FMOA7102, 11FMOA7119, 11FMOA7172, 11FMOA7341, 11FMOA7393, 11FMOA7420, 11FMOA7490, 11FMOA7514, 11FMOA7577, 11FMOA7733, 11FMOA7791, 11FMOA7878, 11FMOA7991, 11FMOA8217, 11FMOA8226, 11FMOA8381, 11FMOA8546, 11FMOA8597, 11FMOA8859, 11FMOA8929, 11FMOA9064, 11FMOA9139, 11FMOA9203, 11FMOA9549, 11FMOA9615, 11FMOA9689, 11FMOA9984, 11FMOB0115, 11FMOB0130, 11FMOB0369, 11FMOB0392, 11FMOB0452, 11FMOB0780, 11FMOB0792, 11FMOB0858, 11FMOB0894, 11FMOB0941, 11FMOB1148, 11FMOB1207, 11FMOB1363, 11FMOB1651, 11FMOB1738, 11FMOB1964, 11FMOB2041, 11FMOB2428, 11FMOB2613, 11FMOB2714, 11FMOB2903, 11FMOB3245, 11FMOB3281, 11FMOB3363, 11FMOB3699, 11FMOB3777, 11FMOB3888, 11FMOB4172, 11FMOB4248, 11FMOB4625, 11FMOB4761, 11FMOB4765, 11FMOB5056, 11FMOB5407, 11FMOB7381, 11FMOB8285, 11FMOB8583, 11FMOB8830, 11FMOB9356, 11FMOB9721, 11FMOC6341, 11FMOC6885 Class II Blood products, collected from donors who may not have had a complete physical examination, were distributed. BioLife Plasma Services L.P.
Biologics Human Cornea for Transplant Preserved in Optisol GS --- Single Patient Use --- Lions Eye Bank at Albany 518-489-7606 NY1301009 R1 (Right) and NY1301009 L1 (Left); Class II Human Corneas, not tested to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed. Sight Society of Northeastern New York Lions Eye Bank@Albany
Devices Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Lossy compressed mammographic images and digitized film screen images may only be interpreted using an FDA approved monitor that offers at least 5 M pixel resolution and meets other technical specifications reviewed and accepted by the FDA. Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians an assistants. Software Versions: 3.7.1, 3.7.1.1, 3.7.2, 3.7.3.1, 3.7.3.3, 3.7.3.4, 3.7.3.5, 3.7.6.3, 3.7.3.7, and 3.7.3.8 Class II Multiple issues were identified with the GE Centricity PACS-IW system that could pose a safety risk to patients. These issues include: 1) With Auto-Fetch in use another patient's image may appear without user's intention. 2.a) In the case where dose administration time and image acquisition time fall on either side of midnight, the value will be under reported and close to zero for all pixel. 2.b) Decay correction tag (0054,1102) has a value "ADMIN" and the value reported will be exceedingly high. 2.c) In the "BQML" case where StartDateTime tag (0018,1078) is provided in place of StartTime (0018,1078) no value is reported and instead shows as "not calibrated". 3) For multi-frame images that contain more than one overlay, studies with frames where overlays overlap, the wrong overlay is displayed. For studies with frames that should display one overlay for specified amount of frames and a second overlay for specified amount of frames, no overlays are displayed at all. Ge Healthcare It
Devices Carestream DRX-Revolution Mobile X-ray System. Produces radiographic images. Serial Numbers: 111, 114, 119-123, 125-126, 134, 142-143, 151-155, 161-169, 173-178,180-183, 188-192, 196-209, 211, 221-232, 235-249, 254, 261-270, 275-276, 279-286, 305, 312, 316-326, 330-337, 339-349, 353, 355, 357-365, 372-373, 375-376, 379-385, 387-388, 394-401, 403-405, 409-410, 412-415, 417, 420-421, 423, 431-435, 441-446, 451-461, 464-470, and 482-490 Class II Carestream Health Inc. is recalling the power plug on their DRX-Revolution Mobile X-Ray System due to the item generating sparks and becoming warm to touch. Carestream Health, Inc.
Devices The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure. GE Centricity PACS Versions: 3.1.1.2, 3.2, 3.2.0.1, 3.2.0.2, 3.2.1, 3.2.2, 3.2.2.1, 3.2.2.2, 3.2.2.3, 3.2.6, 4.0, 4.0.1 Class II GE has recently become aware of potential issues due to out of context issues associated with specific workflows of the Centricity PACS RA1000 workstation. These issues are as follows: 1) In Centricity RIS-IC, and a RIS-Driven integration, the "close" button closes the exam in RIS-IC, but does not close the exam in Centricity PACS RA1000 Workstation. 2) Interrupted workflow could break the synchronization between Nuance PowerScribe 360 and Centricity PACS RA1000 Workstation. 3) Interrupted workflow could break the synchronization between Agfa Talk and Centricity PACS RA1000 Workstation. GE Healthcare It
Biologics Red Blood Cells Leukocytes Reduced W036810061996; Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics Platelets Pheresis Leukocytes Reduced W036809202625; Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics Fresh Frozen Plasma W036810196346; W036810061996; W036809202625; 2547164; Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics Red Blood Cells W036810196346; 2547164; 2369454; Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics Cryoprecipitated AHF 2369454; Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Biologics Platelets Pooled Leukocytes Reduced W036810815344; W036810802056; 2927802; 2911416; Class II Blood products, collected from an ineligible donor, were distributed. OneBlood / dba CBCF
Devices pocH-100i; sysmex; Automated Hematology Analyzer; 7.3" x 13.8" x 18.1" / 30.8 lbs.; Sysmex Corporation; 1-5-1 Wakinohama-Kaigandori, Chuo-ku, Kobe 651-0073, Japan; Sysmex America, Inc; One Nelson C. White Pkwy, Mundeline, IL 60060, U.S.A. The Sysmex pocH-100i Automated Hematology Analyzer is an automated cell counter intended for in vitro diagnostic use in CLIA non-waived clinical laboratories (not for Point of Care use in a CLIA waived laboratory). The Complete Blood Cel (CBC) count test parameters include: WBC, RBC, HGB, HCT, MCV, MCH, MCHC, RDW-CV, RDW-SD, PLT, MPV, and NEUT%/#, LYMPH %/#, MIXED %/# (EO, BSO, MONO). Product Code: 023-1861-8; Serial Numbers: B1677 - B1826, F1827 - F2161, F2178 - F2198, F2216 - F2396, F2411 - F2452, F2464 - F2472, F2495 - F2523, F2533, F2550 - F2560, F2592 - F2601, F2614 - F2635, F2640 - F2648, F2662 - F2679, F2710 - F2853, F2855 - F2871, F2878 - F2922, F2945, F2946, F2962 - F2970, F2998 - F3008, F3072 - F3080, F3083 - F3098 Class II The data printed on the thermal printer may omit a digit or decimal point in the results or sample identification number. Sysmex America Inc
Biologics Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W135 Combined M12118; Class II Lot of MENVEO Meningococcal (Groups A, C, Y and W-135) Oligosaccharide Diphtheria CRM-197 Conjugate Vaccine, with higher than specified levels of residual moisture, wwas distributed. NOVARTIS VACCINES AND DIAGNOSTICS S.r.l
Biologics Blood and Blood Products for Reprocessing 03LR08799 Class III Blood product, collected from an ineligible donor, was distributed. The American National Red Cross - Southern Region
Biologics Red Blood Cells Leukocytes Reduced 004FJ98810; 004LV09482; 004LV10277 Class III Blood products, collected from an ineligible donor, were distributed. Arc Blood Services, New England Region
Devices Multipolar® Bipolar Cup METAL SHELL 38 MM OD through 71 MM OD. Indicated in fracture dislocation of the hip. Part Number Range: 00-5001-038/072-00 Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices CPT® Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SIZE 1 COCR; CPT 12/14 SIZE 1 COCR EXT CPT 12/14 STEM SIZE 2 COCR; CPT 12/14 SIZE 2 COCR EXT; CPT 12/14 SIZE 2 COCR 180MM; CPT 12/14 SIZE2 COCR XEXT; CPT 12/14 STEM SIZE 3 COCR; CPT 12/14 SIZE 3 COCR EXT; CPT 12/14 SZ 3 COCR 180MM EXT; CPT 12/14 SIZE 3 COCR XEXT; CPT 12/14 STEM SIZE 4 COCR; CPT 12/14 SIZE 4 COCR EXT; CPT 12/14 SIZE 4 COCR EXT; CPT 12/14 SZ 4 COCR 230MM EXT; CPT 12/14 SZ 4 COCR 260MM EXT; CPT 12/14 SIZE 4 COCR XEXT; CPT 12/14 STEM SIZE 5 COCR; CPT 12/14 SIZE 5 COCR EXT; CPT 12/14 SIZE 5 COCR XEXT; CPT 12/14 STEM 2-180 VALGUSNCK; CPT 12/14 STEM 3-180 VALGUSNCK; CPT 12/14 STEM X-SML COCR; and CPT 12/14 STEM SML COCR). Indicated for cemented use in patients suffering from severe hip pain. Part Number Range: 00-8114-000/050-00/30 Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices Versys® Beaded Fullcoat Femoral Stem (POR FULL-CT FEM ST 11X160MM; VERSYS BEADED FC 11X200MM 8ST; POR FULLCT FEM ST 11 LOW EXT; POR FULLCT FEM ST 11 EXT; POR FLCT FEM STEM LM 11X160MM; POR FULLCT LM FEM ST 11 EXT POR FULL-CT FEM ST 12X160MM VERSYS BEADED FC 12X200MM 8 ST POR FULLCT FEM ST 12 LOW EXT POR FLCT FEM ST 12.0X190 STR POR FULLCT FEM ST 12 EXT POR FULL-CT FEM ST LM 12X160MM POR FULLCT LM FEM ST 12 EXT POR FULL-CT FEM ST 13X160MM VERSYS HIP SYSTEM REVISION FEMORAL BEADED FULLCOAT PLUS COLL POR FULLCT FEM ST 13 LOW EXT POR FLCT FEM ST 13.5X190 STR POR FULLCT FEM ST 13 EXT POR FULL-CT FEM ST LM 13X160MM POR FULLCT LM FEM ST 13 EXT POR FULL-CT FEM ST 14X160MM VERSYS BEADED FC 14X200MM 8 ST POR FULLCT FEM ST 14 LOW EXT POR FULLCT FEM ST 14 EXT POR FULL-CT FEM ST LM 14X160MM POR FULLCT LM FEM ST 14 EXT POR FULL-CT FEM ST 15X160MM VERSYS BEADED FC 15X200MM 8 ST POR FULLCT FEM ST 15 LOW EXT POR FLCT FEM ST 15.0X190 STR POR FLCT FEM ST 15.0X250 STR POR FULLCT FEM ST 15 EXT POR FULL-CT FEM ST LM 15X160MM POR FULLCT FEM ST 15 XEXT POR FULLCT LM FEM ST 15 EXT POR FULL-CT FEM ST 16X160MM VERSYS BEADED FC 16X200MM 8 ST POR FULLCT FEM ST 16 LOW EXT POR FLCT FEM ST 16.5X190 STR POR FLCT FEM ST 16.5X250 STR POR FULLCT FEM ST 16 EXT POR FULL-CT FEM ST LM 16X160MM POR FULLCT FEM ST 16 XEXT POR FULLCT LM FEM ST 16 EXT POR FULL-CT FEM ST 17X160MM VERSYS BEADED FC 17X200MM 8 ST POR FULLCT FEM ST 17 EXT POR FULL-CT FEM ST LM 17X160MM POR FULLCT FEM ST 17 XEXT POR FULLCT LM FEM ST 17 EXT POR FULL-CT FEM ST 18X160MM VERSYS BEADED FC 18X200MM 8 ST POR FLCT FEM ST 18.0X190 STR POR FLCT FEM ST 18.0X250 STR POR FULLCT FEM ST 18 EXT POR FULL-CT FEM ST LM 18X160MM POR FULLCT FEM ST 18 XEXT POR FULLCT LM FEM ST 18 EXT POR FULL-CT FEM ST 19X160MM POR FLCT FEM ST 19.5X190 STR POR FLCT FEM ST 19.5X250 STR POR FULLCT FEM ST 19 EXT POR FLCT FEM STEM LM 19X160MM POR FULLCT FEM ST 19 XEXT POR FULLCT LM FEM ST 19 EXT POR FULL-CT FEM ST 20X160MM VERSYS BEADED FC 20X200MM 8 ST POR FULLCT FEM ST 20 EXT POR FLCT FEM STEM LM 20X160MM POR FULLCT FEM ST 20 XEXT POR FULLCT LM FEM ST 20 EXT POR FULL-CT FEM ST 21X160MM POR FLCT FEM ST 21.0X190 STR POR FLCT FEM ST 21.0X250 STR POR FULLCT FEM ST 21 EXT POR FLCT FEM STEM LM 21X160MM POR FULLCT FEM ST 21 XEXT POR FULLCT LM FEM ST 21 EXT POR FULLCT FEM STEM 22X160MM POR FLCT FEM ST 22.5X190 STR POR FLCT FEM ST 22.5X250 STR POR FULLCT FEM ST 22 EXT POR FLCT FEM STEM LM 22X160MM POR FULLCT FEM ST 22 XEXT POR FULLCT LM FEM ST 22 EXT. Used in total hip replacement. Part Number Range: 00-7843-011/022-06/56 Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices Metasul® Head. Intended for use either with or without bone cement in total hip arthroplasty. Part Number Range:00-8770-040-01/05 & 01.01062.405/408 Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices CoCr Head (Not distributed in the United States) Used in total hip replacement. Part Number Range:01.01012.405/408 Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices NexGen® Femoral Component (CR-FLEX GSF PRECOAT SZ C-L; CR-FLEX GSF PRECOAT SZ C-R ; CR-FLEX GSF PCT SZ C-L MINUS; CR-FLEX GSF PCT SZ C-R MINUS ;CR-FLEX GSF PRECOAT SZ D-L; CR-FLEX GSF PRECOAT SZ D-R ;CR-FLEX GSF PCT SZ D-L MINUS ; CR-FLEX GSF PCT SZ D-R MINUS ;CR-FLEX GSF PRECOAT SZ E-L CR-FLEX GSF PRECOAT SZ E-R ;CR-FLEX GSF PCT SZ E-L MINUS ;CR-FLEX GSF PCT SZ E-R MINUS ;CR-FLEX GSF PRECOAT SZ F-L ;CR-FLEX GSF PRECOAT SZ F-R ;CR-FLEX GSF PCT SZ F-L MINUS ;CR-FLEX GSF PCT SZ F-R MINUS ;CR-FLEX GSF PRECOAT SZ G-L ;CR-FLEX GSK PRECOAT SZ G-R ;CR-FLEX GSF PCT SZ G-L MINUS ;CR-FLEX GSF PCT SZ G-R MINUS ; LPS-FLEX GSF OPT SZ C-L ; LPS-FLEX GSF OPT SZ C-R ;LPS-FLEX GSF OPT SZ D-L ;LPS-FLEX GSF OPT SZ D-R ;LPS-FLEX GSF OPT SZ E-L ;LPS-FLEX GSF OPT SZ E-R ;LPS-FLEX GSK OPT SZ F-L ;LPS-FLEX GSF OPT SZ F-R ;LPS-FLEX GSF OPT SZ G-L ; LPS-FLEX GSF OPT SZ G-R ;CR-FLEX PCT FEM B-L; CR-FLEX PCT FEM B-R; CR-FLEX PCT FEM C-L; CR-FLEX PCT FEM C-R; CR-FLEX PCT FEM C-L MINUS; CR-FLEX PCT FEM C-R MINUS; CR-FLEX PCT FEM D-L; CR-FLEX PCT FEM D-R; CR-FLEX PCT FEM D-L MINUS; CR-FLEX PCT FEM D-R MINUS; CR-FLEX PCT FEM E-L; CR-FLEX PCT FEM E-R; CR-FLEX PCT FEM E-L MINUS; CR-FLEX PCT FEM E-R MINUS; CR-FLEX PCT FEM F-L; CR-FLEX PCT FEM F-R; CR-FLEX PCT FEM F-L MINUS; CR-FLEX PCT FEM F-R MINUS; CR-FLEX PCT FEM G-L; CR-FLEX PCT FEM G-R; CR-FLEX PCT FEM G-L MINUS; CR-FLEX PCT FEM G-R MINUS; CR-FLEX POR FEM B-L; CR-FLEX POR FEM B-R; CR-FLEX POR FEM C-L; CR-FLEX POR FEM C-R; CR-FLEX POR FEM C-L MINUS; CR-FLEX POR FEM C-R MINUS; CR-FLEX POR FEM D-L; CR-FLEX POR FEM D-R; CR-FLEX POR FEM D-L MINUS; CR-FLEX POR FEM D-R MINUS; CR-FLEX POR FEM E-L; CR-FLEX POR FEM E-R; CR-FLEX POR FEM E-L MINUS; CR-FLEX POR FEM E-R; MINUS; CR-FLEX POR FEM F-L; CR-FLEX POR FEM F-R ;CR-FLEX POR FEM F-L MINUS; CR-FLEX POR FEM F-R MINUS; CR-FLEX POR FEM G-L; CR-FLEX POR FEM G-R; CR-FLEX POR FEM G-L MINUS CR-FLEX POR FEM G-R MINUS; CR-FLEX OPT FEM B-L; CR-FLEX OPT FEM B-R; CR-FLEX OPT FEM C-L; CR-FLEX OPT FEM C-R; CR-FLEX OPT FEM C-L MINUS; CR-FLEX OPT FEM C-R MINUS; CR-FLEX OPT FEM D-L; CR-FLEX OPT FEM D-R; CR-FLEX OPT FEM D-L MINUS; CR-FLEX OPT FEM D-R MINUS; CR-FLEX OPT FEM E-L; CR-FLEX OPT FEM E-R; CR-FLEX OPT FEM E-L MINUS; CR-FLEX OPT FEM E-R MINUS; CR-FLEX OPT FEM F-L; CR-FLEX OPT FEM F-R; CR-FLEX OPT FEM F-L MINUS; CR-FLEX OPT FEM F-R MINUS; CR-FLEX OPT FEM G-L; CR-FLEX OPT FEM G-R; CR-FLEX OPT FEM G-L MINUS; CR-FLEX OPT FEM G-R MINUS; LPS-FLEX CO-NID FEM A-L ; LPS-FLEX CO-NID FEM A-R ; LPS-FLEX RECOAT FEMORAL A-L; LPS-FLEX PRECOAT FEMORAL A-R; LPS-FLEX CO-NID FEM B-L ; LPS-FLEX CO-NID FEM B-R ; LPS-FLEX PRECOAT FEMORAL B-L; LPS-FLEX PRECOAT FEMORL B-R; LPS-FLEX CO-NID FEM C-L ; LPS-FLEX CO-NID FEM C-R ; LPS-FLEX PRECOAT FEMORAL C-L; LPS-FLEX PRECOAT FEMORAL C-R; LPS-FLEX CO-NID FEM D-L ; LPS-FLEX CO-NID FEM D-R ; LPS-FLEX PRECOAT FEMORAL D-L; LPS-FLEX PRECOAT FEMORAL D-R; LPS-FLEX CO-NID FEM E-L ; LPS-FLEX CO-NID FEM E-R ; LPS-FLEX PRECOAT FEMORAL E-L; LPS-FLEX PRECOAT FEMORAL E-R; LPS-FLEX CO-NID FEM F-L ; LPS-FLEX CO-NID FEM F-R ; LPS-FLEX PRECOAT FEMORAL F-L; LPS-FLEX PRECOAT FEMORAL F-R; LPS-FLEX CO-NID FEM G-L ; LPS-FLEX CO-NID FEM G-R ; LPS-FLEX PRECOAT FEMORAL G-L; LPS-FLEX PRECOAT FEMORAL G-R; LPS-FLEX PRECOAT FEMORAL H-L; LPS-FLEX PRECOAT FEMORAL H-R ; LPS-FLEX POROUS FEMORAL B-L ; LPS-FLEX POROUS FEMORAL B-R ; LPS-FLEX POROUS FEMORAL C-L ; LPS-FLEX POROUS FEMORAL C-R LPS-FLEX POROUS FEMORAL D-L ; LPS-FLEX POROUS FEMORAL D-R ; LPS-FLEX POROUS FEMORAL E-L ; LPS-FLEX POROUS FEMORAL E-R ; LPS-FLEX POROUS FEMORAL F-L ; LPS-FLEX POROUS FEMORAL F-R ;LPS-FLEX POROUS FEMORAL G-L ; LPS-FLEX POROUS FEMORAL G-R ; LPS-FLEX POROUS FEMORAL H-L ; LPS-FLEX POROUS FEMORAL H-R ; LPS-FLEX OPTION FEMORAL A-L; LPS-FLEX OPTION FEMORAL A-R; LPS-FLEX OPTION FEMORAL B-L; LPS-FLEX OPTION FEMORAL B-R; LPS-FLEX OPTION FEMORAL B-L ; LPS-FLEX OPTION FEMORAL B-R ; LPS-FLEX OPTION FEMORAL C-L; LPS-FLEX OPTION FEMORAL C-R; LPS-FLEX OPTION FEMORAL C-L; LPS-FLEX OPTION FEMORAL C-R; LPS-FLEX OPTION FEMORAL D-L; LPS-FLEX OPTION FEMORAL D-R; LPS-FLEX OPTION FEMORAL D-L; LPS-FLEX OPTION FEMORAL D-R; LPS-FLEX OPTION FEMORAL E-L; LPS-FLEX OPTION FEMORAL E-R; LPS-FLEX OPTION FEMORAL E-L; LPS-FLEX OPTION FEMORAL E-R; LPS-FLEX OPTION FEMORAL F-L; LPS-FLEX OPTION FEMORAL F-R; LPS-FLEX OPTION FEMORAL F-L; LPS-FLEX OPTION FEMORAL F-R; LPS-FLEX OPTION FEMORAL G-L; LPS-FLEX OPTION FEMORAL G-R; LPS-FLEX OPTION FEMORAL G-L; LPS-FLEX OPTION FEMORAL G-R; CR OPTION FEM COMP SIZE C/L; CR OPTION FEM COMP SIZE C/R; CR OPTION FEM COMP SIZE D/L; CR OPTION FEM COMP SIZE D/R; CR OPTION FEM COMP SIZE E/L; CR OPTION FEM COMP SIZE E/R; CR OPTION FEM COMP SIZE F/L; CR OPTION FEM COMP SIZE F/R; CR OPTION FEM COMP SIZE G/L; CR OPTION FEM COMP SIZE G/R; CR PRECOAT FEM COMP SIZE AML; CR PRECOAT FEM COMP SIZE AMR; CR PRC SURF HDN FEM CO-NID AML; CR PRC SURF HDN FEM CO-NID AMR; CR PRECOAT FEM COMP SIZE BML; CR PRECOAT FEM COMP SIZE BMR; CR PRC SURF HDN FEM CO-NID BML; CR PRC SURF HDN FEM CO-NID BMR; CR PRECOAT FEM COMP SIZE C/L; CR PRECOAT FEM COMP SIZE C/R; CR PRC FEM COMP SIZE CML ; CR PRC FEM COMP SIZE CMR ; CR PRC SURF HDN FEM CO-NID C-L ; CR PRC SURF HDN FEM CO-NID C-R ; CR PRC SURF HDN FEM CO-NID CML; CR PRC SURF HDN FEM CO-NID CMR; CR PRECOAT FEM COMP SIZE D/L; CR PRECOAT FEM COMP SIZE D/R; CR PRC FEM COMP SIZE DML ; CR PRC FEM COMP SIZE DMR ; CR PRC SURF HDN FEM CO-NID D-L ; CR PRC SURF HDN FEM CO-NID D-R ; CR PRC SURF HDN FEM CO-NID DML; CR PRC SURF HDN FEM CO-NID DMR; CR PRECOAT FEM COMP SIZE E/L; CR PRECOAT FEM COMP SIZE E/R; CR PRC FEM COMP EML ;CR PRC FEM COMP SIZE EMR ; CR PRC SURF HDN FEM CO-NID E-L ; CR PRC SURF HDN FEM CO-NID E-R ; CR PRC SURF HDN FEM CO-NID EML; CR PRC SURF HDN FEM CO-NID EMR; CR PRECOAT FEM COMP SIZE F/LCR PRECOAT FEM COMP SIZE F/R; CR PRC SURF HDN FEM CO-NID F-L; CR PRC SURF HDN FEM CO-NID F-R; CR PRECOAT FEM COMP SIZE G/L; CR PRECOAT FEM COMP SIZE G/R; CR PRC SURF HDN FEM CO-NID G-L; CR PRC SURF HDN FEM CO-NID G-R; CR PRECOAT FEM COMP SIZE H/L; CR PRECOAT FEM COMP SIZE H/R; CR PRC SURF HDN FEM CO-NID H-L ; CR PRC SURF HDN FEM CO-NID H-R ; CR POROUS FEM COMP SIZE AML; CR POROUS FEM COMP SIZE AMR; CR POR SURF HDN FEM CO-NID AML; CR POR SURF HDN FEM CO-NID AMR; CR POROUS FEM COMP SIZE BML; CR POROUS FEM COMP SIZE BMR; CR POR SURF HDN FEM CO-NID BML; CR POR SURF HDN FEM CO-NID BMR; CR POROUS FEM COMP SIZE C/L; CR POROUS FEM COMP SIZE C/R; NEXGEN POROUS FEMORAL CR SIZE CM, LEFT ; NEXGEN POROUS FEMORAL CR SIZE CM, RIGHT ; CR POR SURF HDN FEM CO-NID CML; CR POR SURF HDN FEM CO-NID CMR; CR POROUS FEM COMP SIZE D/L; CR POROUS FEM COMP SIZE D/R; NEXGEN POROUS FEMORAL CR SIZE DM, LEFT; NEXGEN POROUS FEMORAL CR SIZE DM, RIGHT; CR POR SURF HDN FEM CO-NID DML; CR POR SURF HDN FEM CO-NID DMR; CR POROUS FEM COMP SIZE E/L; CR POROUS FEM COMP SIZE E/R; NEXGEN POROUS FEMORAL CR SIZE EM, LEFT; NEXGEN POROUS FEMORAL CR SIZE EM, RIGHT; CR POR SURF HDN FEM CO-NID EML; CR POR SURF HDN FEM CO-NID EMR; CR POROUS FEM COMP SIZE F/L; CR POROUS FEM COMP SIZE F/R; CR POR SURF HDN FEM CO-NID F/L; CR POR SURF HDN FEM CO-NID F/R; CR POROUS FEM COMP SIZE G/L; CR POROUS FEM COMP SIZE G/R; CR POR SURF HDN FEM CO-NID G/L; CR POR SURF HDN FEM CO-NID G/R; CR POROUS FEM COMP SIZE H/L;CR POROUS FEM COMP SIZE H/R; NEXGEN POROUS FEMORAL CR SIZE HM, LEFT; NEXGEN POROUS FEMORAL CR SIZE HM, RIGHT; NEXGEN PMMA FEMORAL LPS SIZE A, LEFT; NEXGEN PMMA FEMORAL LPS SIZE A, RIGHT; NEXGEN PMMA SURFACED HARDENED FEMORAL LPS SIZE A, LEFT; NEXGEN PMMA SURFACED HARDENED FEMORAL LPS SIZE A, LEFT ; LPS PRECOAT FEM SIZE B-LT;LPS PRECOAT FEM SIZE B-RT; LPS PRECOAT SRF HDN FEM SZ B-L; LPS PRECOAT SRF HDN FEM SZ B-R; LPS PRECOAT FEM SIZE C-LT; LPS PRECOAT FEM SIZE C-RT; LPS PRECOAT SRF HDN FEM SZ C-L; LPS PRECOAT SRF HDN FEM SZ C-R; LPS PRECOAT FEM SIZE D-LT; LPS PRECOAT FEM SIZE D-RT; LPS PRECOAT SRF HDN FEM SZ D-L; LPS PRECOAT SRF HDN FEM SZ D-R; LPS PRECOAT FEM SIZE E-LT; LPS PRECOAT FEM SIZE E-RT; LPS PRECOAT SRF HDN FEM SZ E-L; LPS PRECOAT SRF HDN FEM SZ E-R; LPS PRECOAT FEM SIZE F-LT; LPS PRECOAT FEM SIZE F-RT; LPS PRECOAT SRF HDN FEM SZ F-L; LPS PRECOAT SRF HDN FEM SZ F-R; LPS PRECOAT FEM SIZE G-LT; LPS PRECOAT FEM SIZE G-RT; LPS PRECOAT SRF HDN FEM SZ G-L; LPS PRECOAT SRF HDN FEM SZ G-R; LPS PRECOAT FEM IMPLANT SZ G-L; LPS PRECOAT FEM IMPLANT SZ G-R; NEXGEN PMMA FEMORAL LPS SIZE H, LEFT ;NEXGEN PMMA FEMORAL LPS SIZE H, RIGHT; NEXGEN PMMA SURFACED HARDENED FEMORAL LPS SIZE H, LEFT; NEXGEN PMMA SURFACED HARDENED FEMORAL LPS SIZE H, LEFT; LPS POROUS FEM SIZE B-LT; LPS POROUS FEM SIZE B-RT; LPS POROUS SRF HDN FEM SZ B-LT; LPS POROUS SRF HDN FEM SZ B-RT; LPS POROUS FEM SIZE C-LT; LPS POROUS FEM SIZE C-RT; LPS POROUS SRF HDN FEM SZ C-LT; LPS POROUS SRF HDN FEM SZ C-RT; LPS POROUS FEM SIZE D-LT; LPS POROUS FEM SIZE D-RT; LPS POROUS SRF HDN FEM SZ D-LT; LPS POROUS SRF HDN FEM SZ D-RT; LPS POROUS FEM SIZE E-LT; LPS POROUS FEM SIZE E-RT; LPS POROUS SRF HDN FEM SZ E-LT; LPS POROUS SRF HDN FEM SZ E-RT; LPS POROUS FEM SIZE F-LT; LPS POROUS FEM SIZE F-RT; LPS POROUS SRF HDN FEM SZ F-LT; LPS POROUS SRF HDN FEM SZ F-RT;LPS POROUS FEM SIZE G-LT: LPS POROUS FEM SIZE G-RT; LPS POROUS SRF HDN FEM SZ G-LT; LPS POROUS SRF HDN FEM SZ G-RT; LPS POROUS FEM IMPLANT SZ G-L; LPS POROUS FEM IMPLANT SZ G-R; LPS POROUS FEM SIZE H-LT; LPS POROUS FEM SIZE H-RT; LPS POROUS SRF HDN FEM SZ H-LT; LPS POROUS SRF HDN FEM SZ H-RT; LCCK FEM COMP SZ C-L; LCCK FEM COMP SZ C-R; LCCK FEM IMPLANT SZ C-L; LCCK FEM IMPLANT SZ C-R; LCCK FEM COMP SZ D-L; LCCK FEM COMP SZ D-R; LCCK FEM IMPLANT SZ D-L; LCCK FEM IMPLANT SZ D-R; LCCK FEM COMP SZ E-L; LCCK FEM COMP SZ E-R; LCCK FEM IMPLANT SZ E-L; LCCK FEM IMPLANT SZ E-R; LCCK FEM COMP SZ F-L; LCCK FEM COMP SZ F-R; LCCK FEM IMPLANT SZ F-L; LCCK FEM IMPLANT SZ F-R; LCCK FEM COMP SZ G-L; LCCK FEM COMP SZ G-R; LCCK FEM IMPLANT SZ G-L; LCCK FEM IMPLANT SZ G-R; LPS FEM COMP SZ A-L; LPS FEM COMP SZ A-R; LPS OPTION FEMORAL A-L; LPS OPTION FEMORAL A-R; LPS FEM COMP SZ B-L; LPS FEM COMP SZ B-R; LPS OPTION FEMORAL B-L; LPS OPTION FEMORAL B-R; LPS FEM COMP SZ C-L; LPS FEM COMP SZ C-R; LPS OPTION FEMORAL C-L; LPS OPTION FEMORAL C-R; LPS FEM COMP SZ D-L; LPS FEM COMP SZ D-R; LPS OPTION FEMORAL D-L; LPS OPTION FEMORAL D-R; LPS FEM COMP SZ E-LLPS FEM COMP SZ E-R; LPS OPTION FEMORAL E-L; LPS OPTION FEMORAL E-R; LPS FEM COMP SZ F-L; LPS FEM COMP SZ F-R; LPS OPTION FEMORAL F-L; LPS OPTION FEMORAL F-R; LPS FEM COMP SZ G-L; LPS FEM COMP SZ G-R; LPS OPTION FEMORAL G-L; LPS OPTION FEMORAL G-R; LPS FEM IMPLANT SZ G-L; LPS FEM IMPLANT SZ G-R; LPS FEM COMP SZ H-L; LPS FEM COMP SZ H-R; LPS OPTION FEMORAL H-L; LPS OPTION FEMORAL H-R; LPS FEM IMPLANT SZ H-L; LPS FEM IMPLANT SZ H-R). Provides increased flexion capability. Part Number Range: 005750, 5764, 5950, 5952, 5956, 5960, 5962, 5964, 5966, 5970, 5972, 5990, 5992, 5994, and 5996-011/018-01/92. Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices NexGen® Femoral Component (CR-FLEX GSF POR FEM, C-L; CR-FLEX GSF POR FEM, C-R; CR-FLEX GSF POR FEM, C-L MINUS; CR-FLEX GSF POR FEM, C-R MINUS; CR-FLEX GSF POR FEM, D-L; CR-FLEX GSF POR FEM, D-R CR-FLEX GSF POR FEM, D-L MINUS; CR-FLEX GSF POR FEM, D-R MINUS CR-FLEX GSF POR FEM, E-L; CR-FLEX GSF POR FEM, E-R; CR-FLEX GSF POR FEM, E-L MINUS; CR-FLEX GSF POR FEM, E-R MINUS; CR-FLEX GSF POR FEM, F-L ; CR-FLEX GSF POR FEM, F-R; CR-FLEX GSF POR FEM, F-L MINUS; CR-FLEX GSF POR FEM, F-R MINUS; CR-FLEX GSF POR FEM, G-L CR-FLEX GSF POR FEM, G-R; CR-FLEX GSF POR FEM, G-L MINUS CR-FLEX GSF POR FEM, G-R MINUS; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE C, LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE C, RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE D, LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE D, RIGHT; LPS-FLEX GSF POR FEM, E-L; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE E, RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, LEFT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE F, RIGHT; NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE G, LEFT; and NEXGEN GSF POROUS FEMORAL LPS FLEX SIZE G, RIGHT). Provides increased flexion capability. Part Number Range: 5752 and 5762. Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices Natural-Knee® Flex Femoral Component. Provides increased flexion capability. Part Number Range: 00-5410,5412,5414,and 5416-013/018-01/02. Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices Zimmer® Unicompartmental Knee Femoral Component. Indicated for patients with painful and/or disabling knee joint. Part Number Range:00-5842-011/017-01/02 Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices Gender Solutions" Patello-Femoral Component Part Number Range:00-5926-011/015-01/02 Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices Natural-Knee® II Femoral Component Part Number Range:6212, 6307-00-006/051 Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices Sidus" Head (Not distributed in the United States) Part Number Range: 01.04555.380/525 Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices NexGen CR-Flex Mobile Bearing Tibial Component 9 (Not distributed in the United States) Part Number Range:005930-010/080-01/02 Class II The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. Zimmer, Inc.
Devices DRX Revolution Mobile X-Ray System, Model DRXR-1, Verona Street Rochester, NY 14608 Catalog Numbers 1019397, 1023415, 1023423 --- Made in USA by Carestream Health, Inc. 150 The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas. Serial numbers: U.S. - 134,152,173,174,200,205,222,312,349,353,412, Worldwide Serial numbers: 469, 445, 306, 410, 453, 204, 483, 300, 171, 218 Class II During an audit, Carestream discovered a DRX-1 System that captured an image which displayed an artifact. This issue was discovered in manufacturing. It occurs when the DRX product console software is updated to v5.6b software and the detector is not calibrated before use. Carestream Health, Inc.
Biologics Cornea 2010161C; 2010162C Class III Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 201051C; 201052C Class III Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 2009169C; 2009170C Class III Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. Lions Eye Bank For Long Island
Devices PIPELINE LS ACCESS SYSTEM, 15 Dilator, 5 mm, Insulated The PIPLINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. 287105005 Class II Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. DePuy Spine, Inc.
Devices PIPELINE LS ACCESS SYSTEM, 2nd Dilator, 10 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. 287105010 Class II Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. DePuy Spine, Inc.
Devices PIPELINE LS ACCESS SYSTEM, 3rd Dilator, 14 mm Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. 287105014 Class II Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. DePuy Spine, Inc.
Devices PIPELINE LS ACCESS SYSTEM, 4th Dilator, 18 mm, Insulated The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. 287105018 Class II Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. DePuy Spine, Inc.
Devices PIPELINE LS ACCESS SYSTEM, Holding Clip The PIPELINE LS Dilators and Holding Clip are intended for sequential dilation of soft tissue and enabling proper placement of the Pipeline LS Retractor. 287105090 Class II Dilators and Holding Clip are being used for a secondary function of neuromonitoring, for which it is not 510(k) cleared. DePuy Spine, Inc.
Biologics HLA Fusion Software; version 2.0.0 SP4.1, Catalog ID FUSPGR HLA Fusion Software (version 2.0.0, SP4.1; Catalog ID FUSPGR (With Luminex xPONENT Software 3.1) Class II HLA Fusion Version 2.0.0-SP4.1, with a defect or glitch causing a conversion error giving incorrect test results for certain beads, was distributed. One Lambda Inc
Devices HemoCue® Urine Albumin Microcuvettes, 25 Microcuvettes HemoCue AB Angelholm, Sweden The quantitative, rapid, turbidimetric immunoassay of albumin in human urine using a specially designed analyzer, the HemoCue Albumin 201 Analyzer. The system can be used for the quantitative determination of low levels of albumin in urine for the purpose of screening for, diagnosing, monitoring and to supplement the clinical evidence in the treatment of microalbuminuria. The system is designed for testing using spot samples or timed collections. A quantitative result is obtained within 90 seconds. HemoCue Urine Albumin Microcuvettes are for in vitro diagnostic use only. The HemoCue Albumin 201 Analyzer is only to be used with HemoCue Urine Albumin Microcuvettes Model Number 110608 Lot Number: 1210865, 1210873, 1211878, 1301893, 1302810, 1303836, 1304838, 1304840 and 1304842. Model Number 110610 Lot Number: 1209857, 1210870, 1211874, 1211879, 1212885, 1301803, 1301893, 1302817 and 1302818. Model Number 110611 Lot Number: 1208848, 1208853, 1208854, 1209855, 1209856, 1209858, 1209860, 1209862, 1210863, 1210865, 1210869, 1210871, 1210872, 1210873, 1211875, 1211876, 1211877, 1211880, 1211881, 1212884, 1212887, 1301802, 1301804, 1301805, 1301806, 1302811, 1302812, 1302813, 13028141302815, 1302816, 1302821, 1303823, 1303825, 1303834, 1304837, 1304839, 1304841, 1304843, 1304844, 1304845, 1304846 and 1304847. Model Number 110613 Lot Number: 1303825 Model Number 110615 Lot Number: 1209858, 1211878 Model Number 110616 Lot Number: 1208849, 1208850, 1208851, 1210864, 1210866, 1210867, 1210868, 1210869, 1212883, 1212886, 1212888, 1212889, 1301807, 1301808, 1302809, 1303827, 1303829, 1303830, 1303831, 1303832 and 1303833. Class II HemoCue AB has become aware of a production related problem involving punctured HemoCue® Urine Albumin Microcuvettes single pack pouches. HemoCue AB
Devices HemoCue® Hb 201 Microcuvettes, carton/4 boxes/25 pouches of Microcuvettes, HemoCue AB Angelholm, Sweden Part Number 111715: Lot numbers1208655, 1208658, 1208659, 1208660, 1208663, 1208664, 1209667, 1209669, 1209670, 1209671, 1209672, 1209674, 1209675, 1209677, 1209678, 1210681, 1210683, 1210685, 1210688, 1211690, 1211691, 1211692, 1211694, 1211696, 1211697, 1211699, 1212701, 1212702, 1212703, 1212705, 1212706, 1301708, 1301710, 1301711, 1301712, 1301715, 1301717, 1301719, 1302721, 1302723, 1302725, 1302726, 1303729, 1303734 & 1304737. Part Number 111717: Lot Numbers: 1208657, 1208661, 1208662, 1208665, 1209666, 1209668, 1209673, 1209676, 1210679, 1210680, 1210682, 1210684, 1210686, 1210689, 1211693, 1211695, 1211698, 1212700, 1212704, 1212707, 1301709, 1301713, 1301714, 1301716, 1301718, 1302720, 1302722, 1302724 & 1304738. Part Number 111722: Lot numbers: 1209672, 1210687, 1212701 & 1303727. Part Number 116101; Lot Numbers: 1303730 & 1303735. Class II HemoCue AB has become aware of a production related problem involving punctured HemoCue Hb 201 Microcuvettes single pack pouches. HemoCue AB
Devices Synthes Application Instrument Sternal Zip Flex System intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum and promote fusion Part No.: 03.501.080 with multiple lot numbers: 3783492 3783913 3788496 3822332 7516728 7606881 7635218 7653178 7659168 7666085 7671934 7679825 7689244 7694377 7700691 7705157 7720599 7738572 7738573 7740498 7742713 7767497 7797648 7803768 7806881 7818677 7818682 7821672 7827088 7831855 7833606 7858407 8068078 Class II When using the 1st generation Zip Fix Application Instrument it is possible to cut the implant while the tensioning trigger is being squeezed which could lead to loosening of the implant. Synthes USA HQ, Inc.
Devices Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging Lot Numbers not utilized. Serial Numbers: LGA0792628 LGA0792564 LGA0792565 LGA0792531 LGA0792540 LGA0792541 LGA0792617 LGA0792554 LGA0792626 LGA0792627 LGA0792552 LGA0792616 LGA0792563 LGA0792553 LGA0792615 LGA0792551 LGA0792613 Class II The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly cause the patient to be burned during the procedure:1. The system is set to 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode, and 2) "IQBalance BD" or "IQ Balance" BCD" is displayed on the touch panel as a result of scale setting for PW mode. Toshiba American Medical Systems Inc
Devices Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic imaging Lot Numbers not utilized. Serial Numbers: 99A07Y2151 99E0993437 99K1285044 99F1033857 99F1033858 99F1033859 99K11Z4906 99K11Z4907 99J1114445 99G1094194 99H10X4240 99E0973301 99G1074050 99G1074051 99G1074052 99E0973302 99J1114443 99G1084118 99D0892684 99K1184804 99D08Y2744 99K1285039 99K11Z4917 99E0963141 99E0963157 99E0963158 99E0963168 99D0892680 99D0892687 99D08Z2840 99D0953122 99E0973308 99E09X3463 99F09Z3684 99D08Z2829 99E0993408 99K1285041 99D0892692 99A07Y2109 99E0993414 99E0993415 99K1214940 99E0983369 99D0892688 99D0892689 99D0892691 99D0892693 99C0872552 99C0872568 99A07Y2097 99A07Y2098 99B07Z2248 99E0993436 99E0993445 99K1234985 99D0953125 99K1184805 99K1285046 99K12X5050 99K12X5051 99K12X5052 99K12X5053 99D0912881 99D08Y2762 99D0922958 99D0922959 99D0922960 99H10X4236 99K12Y5055 99K11Z4928 99F09Z3691 99C0872564 99F1043913 99K1244991 99A07Y2086 99E0973304 99G1053958 99J1134603 99E0983371 99A07Y2100 99B07Z2242 99B07Z2251 99F09Z3664 99D0943018 99E09X3467 99D08Y2759 99D08Y2760 99C0872551 99A07Y2089 99D0922957 99H10X4242 99D0953102 99A07Y2092 99A07Y2106 99A07Y2157 99B07Z2233 99B07Z2258 99C0882610 99C0882611 99D0943045 99D0943047 99E0983370 99F1013749 99F1033860 99F1043912 99G1053954 99G1053956 99K11Z4904 99K1285040 99A07Y2094 99H10X4237 99D08Z2826 99G1053962 99F09Z3663 99K11Z4905 99E09X3450 99C0872566 99A07Y2104 99F1013734 99B07Z2260 99A07Y2083 99D0953124 99D0892681 99J1114444 99E0993446 99J1124539 99J1134600 99A07Y2108 99K11Z4929 99A07Y2085 99F1043911 99E09X3462 99C0882619 99D08Y2747 99C0882607 99C0882608 99F1013743 99A07Y2091 99E0993447 99E0993448 99E0973310 99E0983362 99A07Y2159 99A07Y2158 99B07Z2252 99E09X3504 99J1144668 99J1124540 99J1134601 99G1053951 99H10X4239 99I10Z4387 99I10Z4388 99D0922954 99K1164753 99K1265026 99B07Z2249 99H10X4235 99K1194857 99K11X4876 99D0912880 99F1013735 99K11X4864 99G1084120 99G1084121 99G1094181 99G1094182 99G1094183 99K11Z4922 99G1053960 99F1013737 99E0983372 99E0983373 99F09Z3668 99G1064005 99D0943049 99K1285038 99D0892690 99E09X3461 99D0943048 99D0912884 99E0993416 99E09X3460 99G1094184 99A07Y2081 99K11X4870 99B0832365 99B07Z2261 99E09X3458 99E09X3459 99D08Z2838 99D0932997 99D0892682 99D0912879 99G1053961 99G1084117 99D0943020 99I10Z4389 99B0812292 99B0812293 99J1114447 99G1063999 99G1064001 99G1053953 99J1124538 99K12Y5056 99G1094191 99F09Z3685 99D0932999 99F09Z3688 99F09Z3662 99D0953100 99K11Z4916 99D0922953 99E0963177 99E0973303 99E0963169 99F09Z3667 99F09Z3689 99B07Z2243 99E09X3505 99B07Z2254 99E09X3497 99B07Z2259 99D0953126 99B0832368 99E0993434 99E0993435 99A07Y2082 99B0812294 99F09Z3690 99F09Z3660 99F09Z3661 99K12X5054 99H10X4241 99A07Y2090 99F09Z3687 99K1194858 99F09Z3686 99D0912887 99F1013756 99D0912894 99G1094193 99K1164755 99D0912885 99F09Z3669 99F09Z3670 99C0882620 99C0882614 99K1164754 99E09X3451 99I10Z4391 99B0812295 99C0872565 99G1074048 99K1184801 99C0872567 99E0993444 99D08Z2836 99D08Y2746 99D0912896 99A07Y2107 99B07Z2241 99D08Y2745 99A07Y2080 99D0892685 99J1144667 99B07Z2244 99B07Z2245 99B07Z2246 99J1134602 99K11X4872 99K11X4874 99K11X4875 99K11Y4885 99K11Y4886 99A07Y2084 99B07Z2253 99D0912897 99G1074047 99K1214944 99A07Y2102 99A07Y2155 99K11X4863 99K11Z4923 99K1285045 99D0943019 99D0933004 99D0912877 99E0963143 99K1275036 99F09Z3659 99K11Z4925 99E0993412 99A07Y2087 99E0993411 99E0993413 99E0973306 99E0973307 99D0932998 99D08Z2839 99J1124537 99D0953101 99J1144669 99A07Y2103 99B07Z2231 99A07Y2105 99A07Y2152 99C0872550 99C0882606 99D0912895 99F1033856 99E09X3495 99E09X3496 99F09Z3657 99J1124533 99K1214942 99D0892694 99D08Y2758 99D0922961 99E0993407 99D0953094 99J1114448 99E0973309 99A07Y2101 99K1244990 99E09X3465 99C0882618 99F1013750 99F1013755 99J1144650 99K1244993 99A07Y2156 99A07Y2099 99F1013736 99A07Y2093 99K11Z4919 99K11Z4920 99G1053957 99D08Z2837 99C0882617 99D0922962 99D0932995 99E0963176 99B0812291 99K1265027 99F1013744 99F1013745 99J1144648 99B0832366 99D0933003 99E0993410 99K11X4871 99I10Z4390 99K1184802 99K1184803 99B07Z2256 99B07Z2257 99B0812299 99E09X3507 99E09X3508 99E09X3509 99E09X3510 99B07Z2232 99E0963144 99D0912886 99G1084119 99B07Z2255 99K1285042 99C0872549 99F09Z3658 99D0953103 99D0932996 99K1164751 99F1013748 99J1144649 99D0953123 99C0882615 99C0882616 99E0963170 99E0963171 99E0963172 99E0963173 99F09Z3665 99F09Z3692 99F1013738 99F1013742 99E0963154 99E0983359 99F1043914 99F1043915 99F1013741 99E0983360 99E0983361 99F09Z3683 99D0922947 99K1214939 99H10X4233 99H10X4234 99K11Z4903 99K1275037 99K1234986 99K1234987 99K11Z4926 99B07Z2230 99D0892686 99B07Z2247 99K1244992 99F1013746 99F1013747 99E0993438 99E0993442 99K1194859 99K11Z4927 99D08Y2743 99E0983358 99C0882612 99C0882613 99E0993443 99E0973300 99G1094192 99D08Z2830 99F1013758 99E0963142 99K1214943 99K11Z4918 99B0812296 99B0812297 99B0812298 99D0922946 99E0963156 99D0943046 99H10X4238 99A07Y2095 99D08Z2827 99C0882609 99A07Y2096 99A07Y2153 99E09X3466 99K1275035 99F09Z3671 99J1144671 99F09Z3666 99D08Z2828 99G1064002 99G1064004 99E0993409 99E0963140 99E0963155 99F1013757 99E0963174 99E0963175 99E09X3464 99D0892683 99J1144670 99B07Z2240 99B07Z2234 99E09X3449 99K1285043 99E09X3473 99E09X3474 99E09X3475 99B0812300 99E09X3506 99B0832367 99B0832369 99C0872553 99D0912883 99A07Y2154 99J1134604 99J1144646 99J1144647 99A07Y2088 99D0922955 99K1244989 99G1053952 99K11Z4924 Class II The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly cause the patient to be burned during the procedure:1. The system is set to 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode, and 2) "IQBalance BD" or "IQ Balance" BCD" is displayed on the touch panel as a result of scale setting for PW mode. Toshiba American Medical Systems Inc
Devices Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic imaging Lot Numbers not utilized. Serial Numbers: A1G1194387 A1E10Z3293 A1E10Z3294 99A09Y2120 99B09Z2178 99B09Z2179 A1F1143915 A1G1194385 A1G1194394 A1G1194395 A1G1194396 A1E10Z3339 A1E10Z3340 A1E10Z3341 A1G11Z4565 99B09Z2174 A1G1174188 A1G1194355 A1G1194356 A1G1184257 A1G1184258 A1G1194392 A1G1194406 99B1022343 A1F1113439 A1F1133733 A1F1133846 A1C1072756 A1C1072763 A1C1082867 99A09X2090 99A09X2092 A1C1093010 A1G1214637 A1G11Z4566 A1E10Z3295 A1E10Z3308 A1E10Z3312 A1G1194397 A1E10Z3311 A1F1123626 A1F1123633 A1C1082816 A1C1082830 A1C1082837 A1C1082838 A1C1082842 A1C1082843 A1C1082847 A1G1194373 A1F1123624 A1G1194393 A1F1133840 99B1032438 A1F1113440 A1F1113443 A1F1113444 A1F1133863 A1F1123693 A1F1133760 A1F1133772 A1F1133773 A1C1092961 A1C1092970 A1B1062657 A1E10Z3296 A1G11Z4575 A1F1133740 A1F1133780 A1C1093018 A1G1194384 A1F1133776 A1G1184302 A1G1184303 A1G1194364 A1G1194371 A1G1194372 A1C1082874 A1B1062687 A1C1082868 A1C1082873 A1C1082851 A1C1082862 A1C1082856 A1C1082884 A1G1214636 A1C1082861 A1C1082879 A1C1082880 A1C1082885 A1G1184256 A1G1194401 A1E10Z3359 A1E10Z3360 A1E10Z3361 A1E10Z3369 A1E10Z3370 A1E10Z3371 A1F1123625 A1F1113455 A1A1042483 A1B1052583 A1C1072774 A1C1072782 99B1022344 99B1022347 A1A1042474 A1A1042477 A1A1042480 A1A1042496 99B1032444 A1C1092929 99A09X2087 99A09X2091 99A09Y2114 A1G11Z4568 A1F1133737 A1G1194383 99B1032416 99B09Z2173 99B09Z2182 A1G1184276 A1E10Z3306 A1E10Z3307 A1F1123614 A1B1062646 A1B1062651 A1G1194379 A1E10Z3326 99B09Z2180 99B09Z2181 A1G11Z4567 A1F1123665 99B09Z2171 A1B1062664 A1B1062665 99B1032437 A1F1143918 A1E10Z3356 A1G1194398 99A09Y2116 99B1012242 A1F1123679 A1G1194377 A1C1092920 99B1012227 A1F1133875 99A09X2094 A1A1042491 A1A1042501 A1B1052571 A1F1113466 99B1022345 99B1022346 A1B1062656 A1B1062691 A1B1062696 A1F1133862 A1A1042513 A1B1052569 A1G1184296 99B1012243 A1F1143887 A1B1062634 A1F1133763 A1F1123692 A1E10Z3357 99B1022351 A1G1184289 A1G1184295 A1G1194403 A1F1133762 99B1032447 99A09X2095 99A09Y2113 A1F1143927 A1F1113442 A1F1133764 A1C1072754 A1C1072755 A1C1082823 A1C1072764 A1C1072765 A1C1072773 A1F1113445 A1F1113446 A1F1133789 A1B1052590 A1E10Z3347 A1E10Z3348 A1E10Z3352 A1E10Z3354 A1G1194399 A1B1062660 A1F1143926 A1C1093009 A1G1194376 A1F1113438 A1B1062675 A1G11Z4592 99B1012226 A1G1184254 A1F1143897 A1E10Z3372 A1E10Z3373 99B1032424 A1F1133795 A1F1133819 99B09Z2185 99B1022348 99B1022349 A1F1143891 A1F1143892 A1G1174186 A1B1052572 A1B1062674 A1F1143885 A1G1194381 A1G1194380 A1G1184277 A1G1184282 A1F1143907 99B1012240 99A09X2086 99B09Z2170 A1B1062628 A1F1133734 99B1022337 99B1022338 99B1022339 99B1022340 A1F1133785 A1G11Z4595 A1F1133786 A1F1133793 A1F1133735 A1F1133747 A1F1133748 99A09Y2119 A1G11Z4564 99A09Y2117 A1F1133848 A1B1052573 A1C1092953 A1G1174189 A1G1194359 A1G1194360 A1G1194361 A1G1194362 A1B1062661 A1A1042487 A1G1244755 A1F1123666 A1F1123667 A1F1113458 A1F1113441 A1F1133774 A1C1092937 A1F1143877 A1G1214639 A1C1072783 A1F1133787 A1F1133788 A1F1133790 99B1012236 99B1012237 99B1012238 99B1012228 99B1012229 A1G1194357 A1F1123634 A1F1123643 A1F1133791 A1F1133838 A1F1133860 A1F1133844 A1F1133847 A1F1113447 A1F1113454 A1E10Z3342 A1E10Z3346 A1E10Z3353 A1G1194405 A1F1113467 A1G1194404 A1C1092921 99B1032433 A1G1194400 99B1032434 99B1032435 A1G1174190 A1G1194358 A1B1062669 99B1032425 99B09Z2172 A1F1133738 A1F1113468 A1E10Z3335 A1F1123615 A1F1113456 A1F1113457 A1F1143898 A1C1092928 A1C1092960 A1F1133845 A1B1052597 A1B1052604 99B1012225 99B1032446 A1F1123680 A1B1062679 A1G1184253 A1G1214638 A1E10Z3292 A1E10Z3305 A1G1184259 A1F1133781 A1F1133782 A1F1133783 A1F1133784 A1E10Z3299 A1E10Z3300 A1E10Z3313 A1E10Z3314 A1E10Z3321 A1E10Z3322 A1E10Z3325 99B1032436 99B1032445 99B1032448 A1E10Z3355 A1C1093016 A1G1174187 99B1022341 99B1022342 A1G1194402 99B1032429 99B1032432 A1F1123644 99B1032430 99B1032431 A1F1123645 A1G11Z4577 A1G11Z4578 A1G11Z4579 A1G11Z4591 99B09Z2186 99B09Z2187 99B09Z2188 99B09Z2189 99B1012235 A1C1092936 A1E10Z3319 A1E10Z3320 A1E10Z3327 A1E10Z3328 A1E10Z3332 A1E10Z3333 A1E10Z3334 A1G1194382 A1G1194363 A1G11Z4593 A1F1133876 A1G11Z4576 99B1032418 99B1032419 99B1032420 A1B1052576 99B1012244 A1B1062640 A1F1143893 A1F1143894 A1F1143895 A1F1143902 99B1012241 A1B1062683 A1F1113470 A1F1133821 A1F1133820 A1F1133859 A1F1143884 A1F1143889 A1G1184255 A1F1113469 A1G1194386 A1B1062670 A1F1123695 A1F1123696 A1A1042507 A1C1092971 A1C1092980 A1C1092989 A1C1092999 99B1032428 A1F1133839 A1F1133775 A1G1214635 A1F1123694 A1G1244751 A1G1244752 A1G1244753 A1G1244754 A1F1143888 A1F1133761 A1F1133794 A1G1184283 A1G1184288 A1G11Z4594 A1F1133822 A1F1133823 A1F1133836 A1G1194378 99B1022350 99A09X2089 A1F1133861 A1C1092944 A1C1092945 A1C1092952 A1F1143886 99B1012239 99A09Y2118 A1F1143922 A1F1133739 99A09X2093 A1F1133837 A1C1093017 99B1032417 Class II The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly cause the patient to be burned during the procedure:1. The system is set to 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode, and 2) "IQBalance BD" or "IQ Balance" BCD" is displayed on the touch panel as a result of scale setting for PW mode. Toshiba American Medical Systems Inc
Devices Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic imaging Lot Numbers not utilized. Serial Numbers: 99D0833447 99E0873714 99G0995029 99D0823343 99F0924404 99G09Y5216 99E0863552 99E0863553 99G0964771 99C0792920 99F0893870 99B06Z2073 99C07X2964 99C0792918 99B06Z2063 99C0792919 99G0964712 99G0964713 99G0974899 99F0944563 99D0823349 99G0995131 99G0995132 99G0995133 99G0995134 99G09Y5224 99C0792914 99D0813229 99D0813230 99D0813231 99E0873711 99E0873716 99E0873717 99B06Z2072 99B0752508 99B0752509 99B0752510 99B0752511 99C0792915 99C0792937 99F0893967 99F08Y4079 99F08Y4085 99F08Y4086 99F0924389 99F0924395 99F0924405 99B06Z2107 99G1045683 99C07Y3068 99C07Y3069 99B0782760 99C07Y3047 99B0722268 99B0722269 99B0722270 99B0722271 99B0722272 99B0732349 99B0732350 99B0732351 99B0732352 99B0732353 99B0732354 99E0863691 99E0863692 99G0995139 99B0722208 99B0722250 99F0934520 99C0782863 99B06Z2061 99G0995071 99G09Y5260 99G09Y5261 99D0813225 99D0813226 99E0863586 99E0863587 99C0782860 99G0964777 99B0752531 99D07Z3138 99D0813224 99B0752532 99D07Z3139 99B06Z2088 99B0722251 99C07X2965 99F0914260 99F0914261 99F0914269 99G09Z5369 99G09Y5256 99F08Y4078 99D0833438 99G09Z5367 99F0893846 99E0873713 99B06Z2071 99C0782864 99C07Y3061 99D0833437 99G0974883 99G0974884 99F0893855 99F0893854 99B0782767 99B0782786 99F0914266 99G1015473 99G09Z5370 99G09Z5374 99G09Z5375 99G1015474 99B06Z2109 99B06Z2068 99B06Z2060 99C0792930 99D0823363 99D0833441 99D0823364 99D0823365 99D0833440 99G09Y5264 99B0722206 99B0722207 99B0722204 99B0752524 99B0752525 99F0914265 99F0914289 99E0873720 99G09Y5257 99F0893866 99F0893969 99D0823351 99B0732355 99B0742413 99B0742414 99G0995135 99D0823342 99E0863572 99D0833450 99E0863549 99E0863550 99E0873712 99E0863570 99E0863571 99B06Z2055 99D0833451 99B0742415 99B0742416 99B0742417 99G09Y5223 99F0914263 99B0722203 99B0782788 99C0782866 99B06Z2062 99F0934528 99B0782766 99B0722201 99F0893961 99F0934532 99G09Z5379 99G1015468 99F0924394 99G1015472 99G09Y5262 99G09Y5263 99B0722252 99G0974886 99F0893868 99F0893869 99G0964772 99F0944536 99F0893851 99F0934527 99G09Y5258 99B0752548 99G1045682 99L1166369 99B06Z2090 99G1015471 99F0893850 99G09Z5382 99G09Z5383 99G0964775 99G0964776 99B06Z2105 99B06Z2110 99F0924392 99C07X2968 99F0944537 99F0944538 99B06Z2070 99C07Y3050 99C07Y3051 99B06Z2058 99B0782789 99G0964715 99D0823346 99D0823347 99D0823348 99G0974887 99G0974897 99G0974898 99F0893848 99G0995027 99D07Z3132 99E0863585 99E0863702 99F0893847 99F0893970 99F0944564 99G09Z5380 99B06Z2114 99B0722254 99C07Y3063 99F0893966 99F0914267 99D0833448 99D0833449 99E0863706 99E0863707 99F0893849 99B0752507 99G0964774 99F0893867 99G0984982 99G0995026 99E0863588 99G0995137 99G0995138 99G09Y5219 99G09Y5220 99F0924396 99F0924397 99B0712171 99B06Z2104 99B0712169 99G0984979 99G1015465 99B0712172 99E0863568 99B0722202 99B0752570 99C07Y3043 99C07Y3044 99C07Y3045 99C07Y3062 99C07Y3064 99C07Y3065 99G0974900 99C0782861 99C07X2967 99F0944566 99B06Z2069 99B0752562 99B0752563 99B0752564 99B0752565 99D0833452 99G1015466 99F0893965 99F0944535 99E0873718 99B06Z2103 99F0934530 99E0873719 99G09Z5377 99G09Z5378 99C0792935 99C0792936 99D0813227 99D0823350 99G0995136 99G09Z5376 99B06Z2056 99B06Z2075 99E0873715 99F0924391 99F0924403 99B0782769 99F0914288 99B0752523 99B06Z2064 99B0712170 99B0752551 99B06Z2113 99E0863584 99F0893852 99F0893853 99G0964711 99G0995072 99F0924393 99B0782768 99G09Z5384 99G09Z5385 99B0752550 99E0863569 99C0782859 99B06Z2092 99G1015476 99G09Y5221 99G09Y5215 99E0863693 99E0863694 99E0863695 99E0863696 99E0863697 99E0863698 99C0792912 99B06Z2066 99G0984981 99C0792917 99D0823345 99F0914290 99F0914291 99F0914292 99F0924401 99G09Z5371 99G09Z5372 99G09Z5373 99L1166370 99F0893968 99E0863551 99F0893962 99F08Y4080 99F0914259 99G0984978 99F08Y4082 99F08Y4083 99F08Y4084 99F0934519 99F0893964 99F0934533 99D0833442 99F08Y4077 99B06Z2074 99F0914262 99F0934529 99G09Y5222 99B06Z2116 99B0782764 99B0782765 99E0863699 99B0712173 99B0712174 99G0984980 99B0782759 99E0863705 99C07Y3046 99D0813228 99B0752561 99C07Y3048 99B06Y2048 99B06Z2057 99B06Z2108 99C07X2966 99G0974885 99G1015470 99B06Y2051 99B06Z2115 99F0934526 99B0782763 99D0833436 99D0813233 99G1015475 99G09Y5259 99C0792916 99G0995028 99C0792931 99B06Y2050 99B06Z2112 99G0974896 99D0833443 99F0944539 99B06Z2102 99C0782862 99C0792913 99C07X2963 99G09Z5368 99B0752549 99G09Y5217 99G09Y5218 99E0863688 99G0964769 99G0964770 99C07X2969 99G0964773 99F08Y4081 99C0792934 99F0914268 99C0792933 99D07Z3134 99E0863689 99D0823344 99D07Z3133 99B0712168 99G0964714 99C07Y3052 99C07Y3049 99D0833444 99D0833445 99B0782787 99C0782858 99D0833453 99B0722205 99B06Z2091 99G1015467 99B0752547 99E0863690 99G0964778 99F0934531 99B06Z2106 99E0863701 99D0833439 99D0813232 99E0863704 99B06Y2049 99B06Z2067 99F0924402 99G0995140 99B0722253 99F0944565 99G09Y5265 99G09Z5364 99G09Z5365 99G09Z5366 Class II The firm initiated this recall of certain Toshiba Diagnostic Ultrasound Systems because it has been found that under certain conditions, the temperature of the transducer head may increase in 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode. When the system is used under both conditions listed below, the temperature of the transducer head connected to the system may increase in temperature and possibly cause the patient to be burned during the procedure:1. The system is set to 2D+PW mode or 2D+CDI (POWER, ADF) +PW mode, and 2) "IQBalance BD" or "IQ Balance" BCD" is displayed on the touch panel as a result of scale setting for PW mode. Toshiba American Medical Systems Inc
Biologics Honey Bee Venom A1200016; A1200053; A1300028; A1300051; M26969B; M26969F; M32153B; A1200030; A1200090; A1300033; D26969A; D26969E; D32153A; A1200054; A1200121; A1200006; A1300059; Class II Diluent containing phenol failed an apperance test on stability. The Diluent is included in the JHS licensed venomil kits that were distributed. Jubilant HollisterStier, LLC
Biologics White Faced Hornet Venom Protein A1200032; A1200100; A1300043; M26862H; A1200019; A1200080; A1200123; A1300031; D26862F; A1300025; D26862E; A1200079; M26862I Class II Diluent containing phenol failed an apperance test on stability. The Diluent is included in the JHS licensed venomil kits that were distributed. Jubilant HollisterStier, LLC
Biologics Yellow Hornet Venom Protein A1200035; A1200099; A1300032; M26865I; A1200018; A1200125; A1300034; D26865H; A1200007; D26865G; A1200005; A1200078; A1200089; M26865F Class II Diluent containing phenol failed an apperance test on stability. The Diluent is included in the JHS licensed venomil kits that were distributed. Jubilant HollisterStier, LLC
Biologics Wasp Venom Protein A1200115; A1200052; A1200057; A1300029; M29636C; M31619A; A1200033; A1200104; A1300035; D29636B; D31619B; A1200009; A1200008; A1200096; A1300068; M29636A Class II Diluent containing phenol failed an apperance test on stability. The Diluent is included in the JHS licensed venomil kits that were distributed. Jubilant HollisterStier, LLC
Biologics Yellow Jacket Venom Protein A1300024; D26968D; D29155C; A1200045; A1200076; M29155A; A1200017; A1200077; D26968E; D29155D; A1300026; M26968F; M29155B Class II Diluent containing phenol failed an apperance test on stability. The Diluent is included in the JHS licensed venomil kits that were distributed. Jubilant HollisterStier, LLC
Biologics Mixed Vespid Venom Protein A1200020; A1200068; A1300030; A1300054; M27840A; M30396B; A1200075; A1300027; M27840B; M30396A; M31296A Class II Diluent containing phenol failed an apperance test on stability. The Diluent is included in the JHS licensed venomil kits that were distributed. Jubilant HollisterStier, LLC
Food Amport Foods Chocolate Raisins. Net Wt. 12 oz (340g). UPC 71725-71190. Allergy Information: This product is produced on equipment shared with peanuts and tree nut products. Lot 078X344 Exp 12-19-13 Class II It was discovered that a package of Milk Chocolate Peanuts was erroneously labeled as Milk Chocolate Raisins. American Importing Co, Inc
Biologics Ortho Verseia Pipetter (VERSEIA) All VERSEIA Pipetters with software Versions 2.2, 2.3, 3.0 and 3.1; (Product Code: 5561701) There is no expiration date for these serialized products. Class III ORTHO VERSEIA Pipetter software, with a defect or glitch that in certain circumstances during plate processing, has the potential for false negative results. Ortho Clinical Diagnostics Inc
Devices Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment. Model Number EG-530UT2. Serial Numbers: NU038A018, NU038A019, NU038A022, NU038A027, NU038A028 and NU038A029 Class II A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps Inlet (biopsy inlet port) to the endoscope. Fujinon Inc
Devices Siemens RAPIDPoint® 400 system blood gas analyzer Product Usage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili All Serial Numbers Class II RAPIDPoint® 400 Series, RAPIDPoint® 500, or RAPIDLab® 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample Siemens Healthcare Diagnostics Inc
Devices Siemens RAPIDPoint® 405 system blood gas analyzer Product PUsage: These systems are intended for near-patient and laboratory testing of blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The systems are capable of determining the following parameters: RAPIDPoint 400 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, Hct RAPIDPoint 405 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili All Serial Numbers Class II RAPIDPoint® 400 Series, RAPIDPoint® 500, or RAPIDLab® 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample Siemens Healthcare Diagnostics Inc
Devices Siemens RAPIDPoint® 500 system blood gas analyzer Product Usage: RAPIDPoint 500 System: The RAPIDPoint 500 system is designed for professional use in a point-of-care or laboratory environment. This system tests blood gases, electrolytes, metabolites, total hemoglobin, and hemoglobin derivatives in arterial, venous, and capillary whole blood samples. The following parameters are tested: pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, F02Hb, FCOHb, FMetHb, FHHb, nBili All Serial Numbers Class II RAPIDPoint® 400 Series, RAPIDPoint® 500, or RAPIDLab® 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample Siemens Healthcare Diagnostics Inc
Devices Siemens RAPIDLab® 1240 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb All Serial Numbers Class II RAPIDPoint® 400 Series, RAPIDPoint® 500, or RAPIDLab® 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample Siemens Healthcare Diagnostics Inc
Devices Siemens RAPIDLab® 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb All Serial Numbers Class II RAPIDPoint® 400 Series, RAPIDPoint® 500, or RAPIDLab® 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample Siemens Healthcare Diagnostics Inc
Devices Siemens RAPIDLab® 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb All Serial Numbers Class II RAPIDPoint® 400 Series, RAPIDPoint® 500, or RAPIDLab® 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample Siemens Healthcare Diagnostics Inc
Devices Siemens RAPIDLab® 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidlab 1200 systems are intended for in vitro diagnostic use by healthcare professionals in the quantitative testing of human whole blood. The systems can determine the following parameters: RAPIDLab 1240 pH, pC02, p02 RAPIDLab 1245 pH, pC02, p02, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb RAPIDLab 1260 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate RAPIDLab 1265 pH, pC02, p02, Na+, K+, Ca++, Cl-, glucose, lactate, tHb, nBili, F02Hb, FCOHb, FMetHb, FHHb All Serial Numbers Class II RAPIDPoint® 400 Series, RAPIDPoint® 500, or RAPIDLab® 1200 Series blood gas analyzer, users can inadvertently enter a wrong patient ID on the demographics screen, which ultimately could lead to a misidentification of the sample Siemens Healthcare Diagnostics Inc
Drugs Bevacizumab 25mg/mL, prepared as pre-filled syringes in 0.05 mL and 0.06 mL sizes, Fallon Wellness Pharmacy, Latham, NY 12110. Lot #: 08052013@84, Exp 11/5/2013 Class II Lack of Assurance of Sterility: Fallon Pharmacy recalled Bevacizumab 25mg/mL due to sterility assurance concerns based on testing of this lot by a third party lab, indicating that test results reported as passing sterility may have been inaccurate. Fallon Wellness Pharmacy Llc
Devices Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) systems. The CT subsystem produces cross sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, brain, heart and other Oran imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions. Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in: The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders The detection, localization, and staging of tumors and diagnosing cancer patients. Treatment planning and interventional radiology procedures. The device includes software that provides a quantified analysis of regional cerebral activity from PET images. Cardiac imaging software provides functionality for quantification of cardiology images and data sets including but not limited to myocardial perfusion for the display of wall motion and quantification ventricular or left-function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium. Both subsystems (PET and CT) can also be operated. Model # 882456; Serial Number: 2003 -2013 and 2015 - 2019. Class II Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the event that a patient rescan were to require reinjection of PET radiopharmaceutical. Philips Medical Systems (Cleveland) Inc
Devices Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system. R13D09024, R13D09107, R13D12101, R13D17068, R13D18066, R13D20070 Class II Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471 Baxter Healthcare Corp.
Devices Baxter CLEARLINK System Non-DEHP Three Lead Extension Set. 6.0" (15 cm), 1.0 mL, Luer Activated Valve, male Luer Lock Adapter, Sterile, nonpyrogenic, Baxter Healthcare Corporation, Deerfield IL 60015. For use with a vascular access device for the administration of drugs and solutions. The Clearlink Luer Activated Valve is an in-line injection site, which can be connected to standard male Luer adapters for continuous or intermittent fluid administration or the withdrawal of fluids. UR13C11089, UR13D16060 Class II The firm is issuing a voluntary recall due to the potential for pinholes in the packaging. Pinholes are a breach in the sterile barrier and could lead to potential contamination. Baxter Healthcare Corp.
Devices Brand Names: Integra® Camino 110-4 Intracranial Pressure (ICP) Monitoring Catheters. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively. Common Name: Intracranial Pressure and Pressure-Temperature Monitoring Kits Classification Name: Device, Monitoring, Intracranial Pressure 510(k) Number: K102875 The Camino 110-4 Intracranial Pressure monitoring catheters are sterile transducer-tipped pressure monitoring catheters that are used by neurosurgeons to rapidly determine and continuously monitor intracranial pressure or pressure/temperature.  The Camino 110-4B catheter is used for Intracranial Pressure Monitoring in the parenchyma or subarachnoid space.  The Camino 110-4G catheter is used for Post Craniotomy Subdural Pressure Monitoring.  The Camino 110-4H catheter is intended for Intracranial Pressure Monitoring and Cerebrospinal fluid drainage.  The Camino 110-4L catheter is intended for use with the Licox® Brain Oxygen Monitoring System to measure intracranial pressure in the parenchyma.  The fully packaged 110-4B, 110-4H, and 110-4L catheters are also provided as a component in kits that contain other cranial access devices. These kits are Catalogue No. 110-4BC, 110- 4HC, and 110-4LC respectively. Product / Catalogue No.s: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. Lot Numbers: Catalog Number 110-4B: 3050RX195484, 3050RX198473, 305000205426, 3050RX197641, 3050RX201421, 305000205648, 305000205652, 3050RX199149, 3050RX201407, 3050RX199850, 305000205976, 3050RY189979, 3050RX200862, 305000206178, 3050RY193648, 3050RX200486, 3050RX181026, 3050RX185115, 3050RY195484, 305000207061, 305000207062, 3050RY198473, 305000207330, 305000207334, 3050RY197641, 3050RY200862, 305000207580, 305000207892, 3050RY200486, 3050RY181026, 3050RY185115, 3050RX207330, 3050RX207334, 3050RX207580, 305000208008, 305000208510, 3050RY207892, 305000210060, 3050RX208008, 3050RX208510, 3050RX205976, 3050RX206178, 305000210563, 305000211723, 3050RX210060, 305000212616, 305000213007, 305000213191, 30500X210563, 3050RX207061, 305000214590, 3050RX205426, 30500X215502, 3050RX207062, 305000215531, 30500X216410, 3050RY199850, 305000216132, 30500X216627, 30500X217119, 3050RY217112, 305000216718, 3050RX217751, 3050RX217840, 3050RY217837, 305000217858, 30500X218369, 30500X218391, 30500X219054, 3050RY206178, 305000220708, 305000218578, 30500X220430, 305000219261, 30500X221221, 305000221226, 305000219989, 30500X222569, 305000221953, 305000221955, 30500X223153, 30500X223709, 305000223275, 305000223280, 305000222640, 30500X224142, 305000223867, 305000223866, 30500X224692, 305000224352, 305000224353, 30500X225386, 305000225045, 305000225044, 30500X225992, 305000225632, 305000225633, 30500X226540, 30500X227059, 305000226844, 305000226846, 305000226127, 30500X227564, 305000226836, 30500X227820, 305000227127, 305000227128, 30500X228194, 305000227790, 305000227789, 30500X228787, 305000228522, 305000228521, 305000228971, 305000228972, 30500X229560, 305000229328, 305000229329, 30500X229766, 30500X230087, 305000229825, 305000229826, 30500X230565, 305000230303, 305000230302, 30500X231053, 305000230780, 305000230781, 30500X231786, 305000231461, 305000231462, 30500X232331, 305000232098, 305000232099, 30500X232960, 305000232605, 305000232604, 305000233245, 305000233244, 305000233243, 305000233242, 305000233241, 305000233240, 30500X233415, 30500X234183, 305000233607, 305000233608, 30500X234806, 305000234303, 305000234304, 305000235022, 305000235017, 30500X235732, 305000235598, 30500X236328, 305000236105, 305000236104, 305000236655, 305000236653, 30500Y237087, 30500X237090, 305000237232, 30500X237761, 305000237824, 305000237825, 30500X238273, 305000238263, 305000238264, 30500X239095, 305000238818, 305000238819, 30500X239497, 30500X239748, 30500X239958, 30500X240334, 30500X240668, 30500X241368, 305000241516, 305000242236, 305000242792, 305000242795, 305000242796, 305000242794, 305000242793, 305000242791, 3050RY243869, 305000243251, 305000243882, 305000243881, 305000243888, 305000243889, 305000243883, 30500X244281, 30500X244880, 305000244513,30500X245306, 305000244481, 305000244480, 305000244934, 30500X245937, 30500X246067, 305000245408, 30500X246872, 305000245835, 30500X246951, 30500X247608, 305000246460, 30500X248284, 305000247007, 3050RX227127, 3050RX234303, 305000247717, 305000249072, 3050RX242794, 3050RX242793, 3050RX237825, 3050RX241516, 30500X249488, 305000248479, 30500X250423, 305000249743, 30500X250964, 305000250456, 30500X251060, 305000251055, 30500X251560, 30500X252133, 3050RY252136, 305000251453, 30500X252771, 305000252058, 3050RX244513, 305000252646, 305000253785, 30500X254929, 3050RY255145, 30500X255141, 305000254589, 305000255549, 305000255551, 305000255038, 30500X256614, 305000256192, 305000257281, 305000256709, 305000257280, 305000258048, 30500X259385, 305000258379, 305000258921, 305000258922, 30500X259557, 305000259431, 305000259432, 30500X260159, 305000259966, 305000259960, 305000260514, 305000260527, 30500Y261748, 3050RX253785, 305000261325, 305000261326, 305000261737, 305000261736, 3050RX256192, 30500X262441, 305000262328, 305000262327, 305000262978, 305000262977, 3050RY263508, 30500X263559, 305000263504, 305000264073, 305000264074, 305000264625, 305000264624, 3050RY265348, 30500X265422, 30500X265976, 3050RY265975, 305000265530, 305000265527, 30500X266142, 305000266134, 305000266135, 30500X266789, 305000267193, 305000267194, 3050RX261325, 30500X267468, 305000267421, 305000267422, 30500X267990, 305000267673, 305000267674, 305000268294, 305000268293, 305000266784, 305000268914, 305000268915, 3050RX261736, 3050RY269955, 30500X269963, 305000269220, 305000269221, 305000270081, 3050RY271045, 30500X271047, 305000271042, 305000271716, 305000271715, 30500X272367, 305000272273, 305000272274, 305000272852, 305000272851, 30500X274204, 305000273466, 305000273463, 305000274200, 305000274201, 30500X275297, 30500X275393, 305000274816, 30500X276594, 3050RX268914, 305000277761, 3050RY282196, 305000282304, 30500X282815, 3050RY283371, 3050RX283315, 3050RX283314 Catalog Number 110-4G: 3050RX195650, 3050RX198690, 3050RY193969, 3050RY197837, 3050RX199151, 3050RX199942, 3050RX201552, 3050RY185259, 3050RX200538, 305000206177, 3050RX200989, 305000206556, 305000206557, 3050RX200990, 3050RY199151, 3050RY199942, 305000207465, 3050RY200538, 3050RY200989, 305000208007, 3050RY200990, 3050RX207465, 3050RX206557, 3050RX206556, 305000209417, 305000209105, 3050RX208007, 305000210891, 305000211419, 3050RX206177, 30500X209105, 3050RX209417, 305000212298, 30500X210891, 305000213240, 305000214103, 30500X215501, 30500X215577, 3050RX202201, 305000215628, 3050RY195650, 3050RY198690, 30500X216621, 305000216246,3050RY217113, 30500X217118, 305000217140, 30500X217835, 3050RY217839, 305000217464, 30500X218393, 305000218009, 30500X219053, 305000218225, 305000219118, 30500X220001, 30500X220429, 305000219990, 30500X221225, 305000221227, 30500X222567, 305000222642, 305000223279, 30500X223707, 305000223868, 30500X224685, 305000224354, 30500X225383, 305000225046, 305000225634, 30500X226000, 30500X226541, 305000226731, 305000226869, 305000226867, 30500X227567, 305000227129, 30500X228784, 305000228523, 305000228973, 30500X229561, 305000229330, 30500X230084, 305000229827, 305000230304, 30500X231054,305000230782, 30500X231787, 305000231463, 30500X232333, 305000232101, 30500X232776, 305000232606, 30500X233419, 305000233246, 305000233609, 30500X234690, 30500X234807, 305000234306, 305000235566, 30500X236329, 30500Y237088, 30500X237767, 305000237233, 305000238820, 30500X239496, 305000239476, 30500X240336, 30500X241357, 305000241518, 30500X242172, 305000242249, 305000243252, 305000244364, 30500X245304, 305000244935, 305000245409, 305000245838, 30500X246522, 305000246308, 30500X246873, 30500X247609, 30500X248281, 305000249073, 3050RX241518, 3050RX233246, 3050RX242249, 3050RX228973, 30500X251061, 305000251056, 30500X251563, 3050RY252137, 305000252059, 305000252648, 305000254591, 30500X254931, 30500X255143, 305000255039, 305000255548, 305000256193, 305000256737, 305000257244, 305000257246, 305000257921, 305000257920, 305000258303, 305000258290, 30500X259383, 305000258793, 305000259573, 30500X260163, 305000259958, 305000259959, 3050RX254591, 3050RX255039, 305000260513, 305000260512, 30500Y261771, 3050RX257244, 3050RX257920, 305000261159, 305000261160, 3050RY262444, 30500X262443, 305000261734, 305000261732, 305000262325, 305000262326, 3050RX258303, 305000262976, 305000262975, 3050RY263510, 30500X263560, 305000263507, 305000263506, 305000264075, 305000264076, 305000264627, 305000264628, 30500X265424, 305000265525, 305000265524, 30500X265978, 30500X266143, 305000266063, 305000266064, 30500X266787, 305000266638, 305000266637, 305000267191, 30500X267470, 305000267423, 305000267675, 3050RY269957, 30500X274206 Catalog Number 110-4H: 3050RX198281, 3050RY194144, 3050RY198281, 3050RY200861, 30500X223154, 305000220948, 305000223622, 30500X225385, 30500X233417, 305000231714, 305000241350, 30500X243874, 305000250959, 30500X254932, 305000263557 Catalog Number 110-4L: 305000221383, 30500X222566, 305000222762, 30500X223971,305000223969, 305000225078, 30500X226539, 305000226221, 30500X227058, 305000226848, 305000226749, 305000226847, 305000226871, 305000226,870, 30500X228783, 305000229450, 305000229909, 305000230871 30500X232775, 305000232199, 30500X232961, 305000233311, 305000234438, 30500X235731, 305000235181, 305000236201, 305000237368, 305000237369, 305000237799, 305000238539, 305000239102, 30500X240245, 30500X240246, 30500X240247, 305000239736, 305000239737, 30500X241365, 30500X241522, 305000241082, 30500X242170, 30500X245765, 30500X246521, 3050RX237799, 3050RX226749, 3050RX229450, 3050RX241082, 3050RX232199, 3050RY252775, 3050RX240446, 3050RY255148, 305000259553, 305000260626, 305000261835, 305000262436, 3050RX259553, 305000263146, 3050RX260626, 305000264077, 3050RX262436, 3050RX261835, 305000264175, 3050RY265351, 3050RY265766, 305000265531, 30500X266144, 3050RY266146, 30500X266522, 305000266062, 305000267297, 30500X267473, 30500X268133, 305000267784, 305000268412, 3050RX265531, 305000268916, 3050RY271046, 305000271872, 30500X272374, 305000272591, 30500X274210, 30500X274963, 305000281820 Catalog Number 110-4BC: 176044, 177018, 178013, 178898, 179757, 180139, 180955, 182279, 182908, 184079, 184687, 185284, 186277, 187293, 190452, 187780, 190451, 191891, 193414, 194074, 195161, 195608, 196987, 197492, 198189, 198512, 200069, 200490, 199609, 201039, 201595, 202423, 203565, 207077, 208532 Catalog Number 110-4HC: 179758, 180956, 183071, 184686, 186278, 187781, 190450, 192246, 194993, 195450, 198191, 199708, 201040, 201596, 202009 Catalog Number 110-4LC: 162523, 167450, 167786, 175720, 177188, 178547, 182130, 187495, 195245, 197493. Class II Integra LifeSciences has identified through an internal evaluation that in order to comply with US FDA requirements, certain Camino® Intracranial Pressure Monitoring Kits require additional labelling to indicate they are UNSAFE in an MR environment. Only the following Camino® Intracranial Pressure Monitoring Kits are affected: 110-4B, 110-4BC, 110-4G, 110-4H, 110-4HC, 110-4L, 110-4LC. Integra Limited
Food Schwebel's Golden Rich Bun with Honey, 18 oz plastic bag, 12 count, UPC 0 71319 00083 8 Product labeled in part, "INGREDIENTS: ENRICHED WHEAT FLOUR***CONTAINS: WHEAT, SOY SCHWEBEL BAKING CO. YOUNGSTOWN, OH 44501" Lot #CAFC8W, Best By Sept 21, Lot #CAFC7B, Best By Sept 20 Class I Undeclared eggs. Schwebel Baking Company
Devices Globus Medical MicroFuse Putty, 2.5cc and 10cc. Product Usage: MicroFuse Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. MicroFuse Bone Void Filleris a bone graft extender to be used with autogenous bone marrow aspirate or autograft Part number 838.202S (2.5cc), with lot # GBN299BB and expiration date October 2013, and lot #GBN355AB, with expiration date December 2013: and part # 838.210S (10cc) with lot # GBN319AB, with expiration date November 2013, and GBN320BB with expiration date November 2013. Class II The sterility of the product cannot be assured. Globus Medical, Inc.
Devices chromID Salmonella Agar, Reference No. 43621. A selective isolation and differentiation medium for the detection of Salmonella in human specimens. Lot 1002234210 and 1002300040 Class II Complaints for Salmonella strains growing on this medium producing an uncharacteristic white colored colony instead of the expected pale pink to mauve colored colonies. This could potentially lead to Salmonella colonies not being detected. bioMerieux, Inc.
Devices Edwards Lifesciences EMBOL-X Glide Protection System; Model Numbers: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D. The EMBOL-X access device is indicated for the perfusion of the ascending aorta during short-term (less than or equal to0¤ 6 hours) cardiopulmonary bypass (CPB) surgery where procedures may require the hemostatic introduction and removal of compatible intravascular devices into the vascular system. Model No: EXGF24D, EXGF24LLD, EXGF24MMD, EXGF24SSD, EXGF24XLD, EXGF24XSD, EXGFXS2D, EXGF24SS2D, EXGF24MM2D, EXGF24LL2D and EXGF24XL2D. Class I Edwards Lifesciences is recalling certain lots of EMBOL-X Glide Protection System due to deformation of the cannula tip. Edwards Lifesciences, LLC
Food P.F. Chang's Home Menu, Pork & Leek Dumplings, frozen, packaged in 12.5 oz bags. UPC: 0 36200 21215 8 Lot code: 0663 312871 and 0663 312972, Use By MAY082014 and Lot code: 0663 312971 and 0663 312972, Use By MAY092014. Class I The firm is recalling Pork & Leek Dumplings because Shrimp & Pollack Fish dumplings were inadvertently packaged in the Pork & Leek Dumpling packaging. Undeclared allergens. Conagra Inc
Devices Valiant Thoracic Stent Graft with Captivia Delivery System, Talent Thoracic Stent Graft with the Captivia Delivery System. TBXXXXXXXXCP, TFXXXXXXXXCP, TWXXXXXXXXCP, TAXFXXXXXXXCP, TAXWXXXXXXXCP, VAMFXXXXXXXXTE, VAMCXXXXXXXXTE, VAMFXXXXXXXXTU, VAMCXXXXXXXXTU. Class II Firm received reports of difficulty in flushing the graft cover of the delivery system during device preparation as required by IFU. Medtronic Vascular, Inc.
Devices Xoran Mini CT Scanner Minicat Class II A description of the defect in the product or the manner in which the product fails to comply with an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ± 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health hazard was performed on the issue of dose rate/kVp being found outside Xoran's specifications on the MiniCAT CT Scanners. Xoran specifies that the dose rate must be within a tight range. This range is smaller than what is specified as passing by West Physics. West Physics had stated in a report "For this test, a measured effective dose of less than 0.4 mSv is considered satisfactory, and a measured does of greater than 0.23 mSv (but less than 0.4 mSv) will be investigated for possible corrective action." A scanner that falls outside the Xoran specification of 0.23 mSv does not present a danger to the patient. Xoran Technologies, Inc.
Devices MAQUET Getinge Group CARDIOHELP Base Unit REF 70104.7999 REF 70104.8012 Manufactured for: MAQUET Cardiopulmonary AG Made in Germany. Cardiopulmonary support system. Part No. 70104.8012 Serial Nos. 90410440; 90410452; 90410455; 90410456; 90410457; 90410459; 90410469; 90410474; 90410480; 904104781; 90410482; 90410484; 90410498; 90410499; 90410500; 90410501; 90410502; 90410503; 90410521; 90410522; 90410524; 90410526; 90410527; 90410531; 90410533; 90410534; 90410535; 90410550; 90410551; 90410552; 90410568; 90410571; 90410572; 90410573; 90410575; 90410576; 90410577; 90410580; 90410581; 90410582; 90410584; 90410585; 90410592; 90410596; 90410599; 90410600; 90410605; 90410606; 90410607; 90410608; 90410609; 90410610; 90410611; 90410612; 90410626; 90410638; 90410640; 90410642; 90410644; 90410646; 90410647; 90410650; 90410651; 90410652; 90410653; 90410656; 90410659; 90410660; 90410661; 90410662; 90410663; 90410664; 90410665; 90410666; 90410667; 90410668; 90410670; 90410700; 90410708; 90410846; 90410750; 90410786 Class II It has come to the attention of MAQUET that in certain rare instances, the CARDIOHELP-i device may display an error message with audible alarm, indicating "battery defective." The alarm will occur-upon start up or when the main power supply is unplugged from the main power source. The human machine interface touch screen of the CARDIOHELP-i device may gradually become black due to the human machine interface (HMI) back light shutting down. Maquet Medical Systems USA
Devices Xoran MiniCAT CT Scanner Minicat Class II A description of the defect in the product or the manner in which the product fails to comply wvith an applicable Federal standard; The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ± 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health hazard was performed on the issue of dose rate/kVp being found outside Xoran's specifications on the MiniCAT CT Scanners. Xoran specifies that the dose rate must be within a tight range. This range is smaller than what is specified as passing by West Physics. West Physics had stated in a report "For this test, a measured effective dose of less than 0.4 mSv is considered satisfactory, and a measured does of greater than 0.23 mSv (but less than 0.4 mSv) will be investigated for possible corrective action." A scanner that falls outside the Xoran specification of 0.23 mSv does not present a danger to the patient. Xoran Technologies, Inc.
Devices Xoran Minicat00202 minicat Class II The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ± 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health hazard was performed on the issue of dose rate/kVp being found outside Xoran's specifications on the MiniCAT CT Scanners. Xoran specifies that the dose rate must be within a tight range. This range is smaller than what is specified as passing by West Physics. West Physics had stated in a report "For this test, a measured effective dose of less than 0.4 mSv is considered satisfactory, and a measured does of greater than 0.23 mSv (but less than 0.4 mSv) will be investigated for possible corrective action." A scanner that falls outside the Xoran specification of 0.23 mSv does not present a danger to the patient. A copy of the health hazard evaluation may be found in ATTACHMENT 2. Xoran Technologies, Inc.
Devices Xoran Minicat00158 minicat Class II The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ± 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xoran's specifications. See ATTACHMENT 1 for details. (e) A n evaluation of the hazards reasonably related to defect or the failure to comply with the Federal standard; An evaluation of the health hazard was performed on the issue of dose rate/kVp being found outside Xoran's specifications on the MiniCAT CT Scanners. Xoran specifies that the dose rate must be within a tight range. This range is smaller than what is specified as passing by West Physics. West Physics had stated in a report "For this test, a measured effective dose of less than 0.4 mSv is considered satisfactory, and a measured does of greater than 0.23 mSv (but less than 0.4 mSv) will be investigated for possible corrective action." A scanner that falls outside the Xoran specification of 0.23 mSv does not present a danger to the patient. A copy of the health hazard evaluation may be found in ATTACHMENT 2. Xoran Technologies, Inc.
Devices Xoran MiniCAT00202 minicat Class II The MiniCAT CT Scanners subject to this notification failed to meet Xoran's specifications for dose rate of 125 ± 3 kVp. These 18 complaints received include dose rates both on the high and low end of Xorans specifications. Xoran Technologies, Inc.
Devices Xoran MiniCAT CT Scanner ID ENT00001 minicat Class II Failure of the gantry to rotate. The complaint alleged that the scanner would emit radiation but would not rotate. Xoran Technologies, Inc.
Devices REF 5100-088, TPS Micro Driver, For Use with Stryker Total Performance System Caution Federal Law (USA) restricts the device to use by or on the order of a physician Driver, Wire and Bone Drill; The Stryker Total Performance System (TPS) is intended for use in the cutting, drilling, reaming, decorticating and smoothing of bone and other bone related tissues for a variety of applications such as ENT, dental, orthopedic, maxillofacial, spinal, and plastic surgery. The instruments are also used in the placement of screws, wires, pins, and other fixation devices. 10933, 11433, 11483, 20553, 30163, 31553, 40713, 40833, 41113, 50463, 60133, 60423, 90383, 110093, 110193, 1030133, 1030403, 1040413, 2010013, 2010123, 96090403, 96091343, 97020193, 97030013, 97030543, 97050243, 97060163, 97080033, 98010083, 98020703, 98030103, 98040213, 98060023, 98061033, 98070603, 98090023, 98090473, 98090503, 98101143, 98110323, 99010433, 99030253, 99050033, 99050383, 99060163, 99060423, 99061063, 99061283, 99070453, 99071293, 99080243, 99080483, 99090913, 99101273, 221303733, 326102033, 434909453, 500800103, 504900233, 631112793, 631414853, 700314923, 723606673, 725315933, 735502183, 813304543, and 921700523 , Class II It was discovered that the silicone potting failed to properly cure after undergoing the prescribed curing possess. The potting material is used to insulate, stabilize and provide a moisture barrier to the TPS MicroDriver main Printed Circuit Board Assembly (PCBA). Inadequate cure of the silicone potting could potentially allow it to leak to the outside of the handpiece or cause an electrical malfunction (primarily loss of function). Two batches of silicone potting have been identified, by the supplier, as having cure properties that were outside of the specified range. Stryker Instruments Div. of Stryker Corporation
Devices Small Bone Innovations (SBi) rHead Radial Stem, rHead Recon Radial System, rHead Radial Stem Lateral Assembly, rHead Radial Stem 6mm Collar, rHead Recon Radial Stem 6mm Collar, rHead Radial Stem Lateral Assembly 6mm Collar, rHead Standard Extended Stem, rHead Radial Stem Plasma Coated, rHead Recon Radial Stem Plasma Coated, rHead Radial Stem 6mm Collar Plasma Coated, rHead Recon Radial Stem 6mm Collar Plasma Coated, uHead Ulnar Stem Standard, uHead Ulnar Stem 20mm Collar packaged in a sterile pouch inside a shrink-wrapped box. all item numbers and lot numbers Class II The recall was initiated due to an increased risk of implants breaching the sterile pouches inside the shrink-wrapped box. Small Bone Innovations, Inc.
Devices PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standard Air/Water Valve to deliver a non-explosive gas for insufflation. Model OF-B194 Class I PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user. Pentax Medical Company
Devices COULTER® LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 750 Hematology Analyzer provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. The COULTER LH 780 Hematology Analyzer is a quantitative, automated hematology analyzer and leukocyte differential counter For In Vitro Diagnostic Use in clinical laboratories. The COULTER LH 780 Hematology Analyzer also provides automated Reticulocyte analysis and enumeration of nucleated red blood cells (NRBCs) as well as an automated method for enumeration of RBCs and WBCs in body fluids. Part Numbers: 6605362 for the LH 750 and 723585 for the LH 780. Serial Numbers: AJ08102 AK49053 AM09075 AM10078 AG05059 AK41634 AT02015 AL41189 AJ06078 AF22202 AK34502 AL02001 AS49367 AM10085 AJ10154 AM40321 AS41335 AK32475 AS30241 AU28106 AK36538 AL18073 AL18077 AL37150 AH15237 AL09039 AL09042 AK02032 AJ31547 AJ24410 AM24242 AN13074 AN13075 AN13078 AT18112 AT18115 AG45676 AK46036 AG39545 AJ24402 AJ43796 AK49046 AM05019 AH21364 AH21367 AH21368 AH21369 AH21375 AH23391 AT26118 AN11064 AM02006 AE44164 AJ05072 AJ04046 AJ05065 AJ05073 AN19134 AG17221 AH43790 AM20190 AL39172 AT46205 AH43787 AJ04043 AM17139 AM18149 AS35295 AL52333 AF03026 AL50300 AK49040 AL47248 AK11167 AM35324 AS35299 AF44462 AH47839 AJ28468 AG46712 AK46033 AT36156 AT07053 AH38689 AH43782 AG46711 AN19127 AF02009 AJ06081 AJ07089 AE46202 AF06058 AS49369 AG31388 AG48745 AJ08113 AM23218 AG18236 AG21268 AE45183 AL12053 AU10036 AJ23389 AN04028 AN06034 AM40314 AL50405 AK24368 AL52467 AL51444 AG30381 AN25186 AN25187 AM37348 AL46245 AL47251 AG36485 AH29512 AM44418 AM44421 AT02011 AL10069 AN26201 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AL01004 AV20047 AM27251 AS35304 AT12092 AS33283 AM13093 AM13096 AN03009 AN35270 AS10057 AS10060 AT05036 AN32235 AS49372 AS33273 AS33276 AN22173 AN03006 AN32234 AM07050 AM43404 AS15090 AM41374 AM41384 AV20042 AV20044 AV20048 AV20045 AV20046 AV20049 AV20050 AV20051 AV20052 AV20053 AV20055 AL37155 AN20146 AN38304 AS06020 AS19123 AN21165 AS19122 AV06015 AV06016 AV20040 AV20041 AV20043 AN38294 AN11068 AN15093 AN36286 AS25196 AV25076 AV25077 AV25078 AV30080 AV30081 AV30082 AV30083 AV30084 AV30085 AV30086 AV30087 AV30088 AV30089 AS33277 AM43395 AN36284 AS19116 AS27201 AM06029 AN21153 AN21160 AN21161 AN47366 AS02006 AS41353 AS33284 AN20145 AV25066 AS23169 AM31281 AM31296 Class II Beckman Coulter internal investigation indicated that specific lots of check valves used in several locations within the LH 750 and LH 780 analyzers may fail. This failure may result in an air or liquid leak at the connection to the Vacuum Overflow Tank waste line or at the Backwash Tank drain line. Source of initial complaint: Customer laboratory in the United States. Beckman Coulter Inc.
Devices Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is intended to provide increased mobility for elderly and/or disabled person and it is also an aid to independent living. Products can be identified by their color; the recalled products are either metallic blue or metallic silver. The products have two rear wheels and have either one or two wheels in the front. The scooters have an adjustable swivel seat and a front storage basket; some scooters may be fitted with an optional larger rear basket. Serial Numbers: 10390024, 10390025, 10390029, 10390030, 10390034, 10390037, 10490100, 10490108, 10490111, 10490113, 10490119, 10490121, 10490124, 11390058, 11390060, 11390061, 11390069, 11390074, 11390095, 11390101, 11490111, 11490147, 11490176, 11490189, 11490277, 11490304, 11490305, 11490425, 11490426, 11490433, 11490435, 11490445, 12390096, 12390097, 12390098, 12390099, 12390101, 12390102, 12390103, 12390104, 12390105, 12390106, 12390107, 12390117, 12390120, 12490169, 12490170, 12490172, 12490173, 12490174, 12490175, 12490176, 12490177, 12490178, 12490179, 12490180, 12490181, 12490182, 12490183, 12490184, 12490185, 12490186, 12490187, 12490188, 12490189, 12490190, 12490191, 12490192, and 12490193. Class II Breeze C Scooter, motorized 3-wheeled electric scooter for elderly people, is recalled because it may become unresponsive during operation due to an electrical contact which may fault due to extensive wear, which potentially could result in the driver not being able to stop the scooter during operation except by turning off the ignition key. S.A.E. AFIKIM
Devices Brand: The ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT), MASCT System Kits, Clarity System Kits, MASCT Patient Sample Kits & Clarity Patient Sample Kits Instrument, Biopsy. The MASCT System Kit, Patient Sample Kits, or the Nipple Aspirate Fluid Laboratory Kit has the following codes: PRODUCT CODE: AG-MASCT; AG-FC5; DTG-MASCT, DTG-FC5, and NRLBH-5. PART NUMBER: 9002513; 9002513MD; 9002528; 9002528MD; 9002587; 9002614; and 9002717MD. THE MASCT SYSTEM KIT CONSISTS OF: 1. MASCT Breast Pump; 2. Instructions for Use (IFU); 3. Heating Pad; 4. Timer; 5. Saccomono's Fixative; 6. Nu Prep Gel; 7. Welcome and Training Materials Coversheet; 8. MASCT System Order Form; 9. ForeCYTE Training Video DVD; 10. MASCT System Instructions with pictures - pink; THE PATIENT SAMPLE KIT CONSISTS OF: 1. Two (2) flower assemblies (e.g., filter, filter retainer, and filter holder); 2. Instructions for Use (IFU); 3. Two (2) specimen collection devices; 4. Two (2) breast bags for transporting the specimen collection container; 5. Barcode labels; 6. Saccomono's Fixative; 7. Nu Prep Gel; 8. MASCT System package insert; 9. ForeCYTE Test Requisition Form; 10. Patient Information Sheet; 11. Atossa Patient Information; 12. FED EX Clinical PAK; 13. MASCT System Order Form; 14. FED EX Pouch; 15. FED EX Airbill; Product Usage: The MASCT Device is intended for use in the collection of nipple aspirate fluid for cytological testing. The collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells. ALL LOTS Class I Atossa Genetics is recalling ForeCYTE Breast Health Test, Mammary Aspiration Specimen Cytology Test (MASCT) due concerns raised by the U.S. Food and Drug Administration (FDA) in a warning letter received by Atossa in February 2013. The FDA raised concerns about (1) the current Instructions for Use (IFU); (2) certain promotional claims used to market these devices; and (3) the need for FDA clearance for certain changes made to the Nipple Aspirate Fluid (NAF) specimen collection process identified in the current IFU. Atossa Genetics, Inc.
Devices da Vinci Si Surgical System IS3000 with the da Vinci Surgeon Console which contains a high Resolution Stereoscopic Viewer. Intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. model numbers 380610-04 through 38-610-14. Class II Improper restraints during transportation of the da Vinci system could cause the HRSV Monitor to become loose from its mount. Intuitive Surgical, Inc.
Food Pectinase 3,500 ENDO-PG/G, powder, enzyme, 100 gm. Product 70A Lot ALI13157-09; re-evaluation date 12/6/2014. **sample only - not tested On 10/22/2013 American Laboratories provided CFSAN a customer distribution list for the Chloramphenicol Contamination. This spreadsheet listed the base concentrate levels. The data was highlighted: Green, Yellow, Red and Orange.The spreadsheet Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food Xylanase 150,000XU, powder, enzyme, 100 gm. Product 13A Lot ALI13157-11; re-evaluation date 12/6/2014 **sample only - not tested Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food Xylanase 10,000XU/g, powder, enzyme, 100 gm. Product 45A Lot ALI13206-05; re-evaluation date 1/25/2015 **sample only - not tested Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food Xylanase 70,000XU/g, powder, enzyme, 100 gm. Product 71A Lot ALI13206-06; re-evaluation date 1/25/2015 and Lot # ALI13008-13; re-evaluation date 7/8/2014 **sample only - not tested Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food NUT 14-500, powder, plant enzyme blend, packaged in 15 kg and 23 kg double poly bags inside fiber box. Product 98A 15 KGS: Lot ALI13212-04; re-evaluation date 1/31/2015 and 23 KGS: Lot # ALI13036-01; re-evaluation date 8/5/2104. **Lot ALI13212-04 mathmatical analysis tested "probably < 0.3 ppb in final product" **Lot ALI13036-01 mathmatical analysis tested "probably NOT < 0.3 ppb in final product" Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food PC Blend 14, powder, enzyme blend, packaged in 9 kg and 25 kg double poly bags inside fiber box. Product 62A 9 KGS: Lot ALI13249-03; re-evaluation date 3/6/2015 and 25 KGS: Lot # ALI13024-02; re-evaluation date 7/24/2014. **Lots ALI13249-03 and ALI13024-02 mathmatical analysis tested "probably < 0.3 ppb in final product" **Lot ALI13036-01 mathmatical analysis tested "probably NOT < 0.3 ppb in final product" Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food Ultra Blend 102, powder, enzyme blend, packaged in 25 kg double poly bags inside fiber box. Product 73B, SI Item # 10678. Lot # ALI13053-05; re-evaluation date 8/22/2104 **Lot ALI13053-05 mathmatical analysis tested "VERY probable NOT < 0.3 ppb in final product" Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food EB 110311-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 73C Lot # ALI13200-09, re-evaluation date 1/19/2015; Lot # ALI13140-03, re-evaluation date 11/20/2014; Lot # ALI13071-01, re-evaluation date 9/12/2014 and Lot # ALI13008-01; re-evaluation date 7/8/2014. **Lot ALI13200-09 mathmatical analysis tested "probably < 0.3 ppb in final product" **the other three lots mathmatical analysis tested "probably NOT < 0.3 ppb in final product" Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food EB 020812-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 77C Lot # ALI13200-08, re-evaluation date 1/19/2015; Lot # ALI13140-02, re-evaluation date 11/20/2014; Lot # ALI13071-02, re-evaluation date 9/12/2014 and Lot # ALI13008-02; re-evaluation date 7/8/2014. **Lot ALI13200-08 mathmatical analysis tested "probably < 0.3 ppb in final product" **the other three lots mathmatical analysis tested "probably NOT < 0.3 ppb in final product" Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food Red and Green Bell Peppers, 25 lbs. Lot # SB 7 920, SB 7 923, SB 7 924 Class I Orange County Produce, LLC is recalling fresh red and green Bell Peppers because they may have the potential to be contaminated with Salmonella. Orange County Produce
Food St. Marcellin Au lait pasteurise fabrique en Dauphine l'unite: poids net 80ge Fromagerie Qurtet 38470 VINAY Lot #13U219, Lot # 13U225 Class I The French Ministry of Food, Agriculture is requiring cheese to be withdrawn from sales at all levels of distribution as L. monocytogenes was detected in thermised (heat-treated/not pasteurized) product in France which was not exported. Epicure Food Corp.
Food 10 inch Apple Pie (baked and unbaked), NET WT 42 oz.(2 lb 10 oz), UPC 41735-22064 (unbaked) and 41735-23712 (baked), Price Chopper label. All Sell By dates from Sept 25, 2013 through Oct 9, 2013 Class II The product contains undeclared eggs. Price Chopper Supermarkets
Devices BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT), one unit per box. BrightView XCT is a gamma camera for Single Photon Emission Computed Tomography (SPECT) and integrates with an attenuation device consisting of flat panel x-ray imaging components. BrightView XCT produces non-attenuation corrected SPECT images and attenuation corrected SPECT images with x-ray transmission data that may also be used for scatter correction. The nuclear medicine images and the XCT images may be registered and displayed in a fused format (overlaid in the same orientation) to provide anatomical localization of the nuclear medicine data. The following model and serial numbers are affected by this recall: Model Number: 882454 Serial Number(s): 11000021, 11000082, and 11000111. Model Number: 882482 Serial Number(s): 6000002, 6000003, 6000004A, 6000005, 6000010, 6000011, 6000012, 6000013, 6000015, 6000016, 6000017, 6000018, 6000019, 6000020, 6000022, 6000023, 6000024, 6000025, 6000026, 6000027, 6000028, 6000029, 6000030, 6000031, 6000033, 6000036, 6000037, 6000038,6000040,6000041, 60000042, 6000043, 6000044, 6000045, 6000047, 6000048, 6000049, 6000050, 6000051, 6000052, 6000053, 6000054, 6000055, 6000056, 6000058, 6000059, 6000060, 6000061, 6000062, 6000063, 6000064, 6000065, 6000066, 6000067, 6000069, 6000070, 6000071, 6000072, 6000073, 6000074, 6000076, 6000077, 6000078, 6000079, 6000080, 6000081, 6000082, 6000083, 6000084, 6000085, 6000086, 6000087, 6000088, 6000089, 6000090, 6000091, 6000092, 6000093, 6000094, 6000095, 6000096, 6000097, 6000098, 6000099, 6000100, 6000101, 6000102, 6000103, 6000104, 6000105, 6000106, 6000107, 6000108, 6000109, 6000110, 6000111, 6000112, 6000113, 6000114, 6000115, 6000116, 6000117, 6000118, 6000119, 6000120, 6000121, 6000122, 6000123, 6000125, 6000126, 6000127, 6000128, 6000129, 6000130, 6000131, 6000132, 6000133, 6000134, 6000136, 6000138, 6000139, 6000140, 6000141, 6000142, 6000143, 6000144, 6000145, 6000146, 6000147, 6000148, 6000149, 6000150, 6000151, 6000152, 6000153, 6000154, 6000155, 6000156, 6000157, 6000158, 6000159, 6000160, 6000161, 6000162, 6000163, 6000164, 6000165, 6000166, 6000167, 6000168, 6000169, 6000170, 6000171, 6000172, 6000173, 6000174, 6000175, 6000176, 6000177, 6000178, 6000179, 6000180, 6000181, 6000182, 6000183, 6000184, 6000185, 6000186, 6000187, 6000188, 6000189, 6000190, 6000191, 6000192, 6000193, 6000194, 6000195, 6000196, 6000197, 6000198, 6000199, 6000200, 6000201, 6000202, 6000203, 6000204, 6000205, 6000206, 6000208, 6000209, 6000210, 6000211, 6000212, 6000213, 6000214, 6000215, 6000216, 6000217, 6000218, 6000219, 6000220, 6000221, 6000222, 6000223, 6000224, 6000225, 6000226, 6000227, 6000228, 6000229, 6000230, 6000231, 6000232, 6000233, 6000234, 6000235, 6000236, 6000237, 6000238, 6000239, 6000240, 6000241, 6000242, 6000243, 6000244, 6000245, 6000246, 6000247, 6000249, 6000250, 6000251, 6000252, 6000253, 6000254, 6000255, 6000256, 6000257, 6000258, 6000259, 6000260, 6000262, 6000263, 6000264, 6000265, 6000266, 6000267, 6000268, 6000269, 6000270, 6000271,6 000272, 6000273, 6000274, 6000275, 6000276, 6000277, 6000278, 6000279, 6000280, 6000281, 6000282, 6000283, 6000284, 6000285, 6000286, 6000287, 6000288, 6000290, 6000291, 6000292, 6000293, 6000294, 6000295, 6000296, 6000297, 6000298, 6000299, 6000300, 6000302, 6000303, 6000305, 6000306, 6000307, 6000308, 6000309, 6000310, 6000311, 6000312, 6000313, 6000314, 6000315, 6000316, 6000317, 6000318, 6000319, 6000320, 6000321, 6000322, 6000323, 6000324, 6000325, 6000326, 6000327, 6000328, 6000329, 6000330, 6000331, 6000332, 6000333, 6000334, 6000335, 6000336, 6000337, 6000338, 6000339, 6000341, 6000342, 6000343, 6000344, 6000345, 6000348, 6000349, 6000350, 6000351, 6000352, 6000353, 6000354, 6000355, 6000356, 6000357, 6000358, 6000359, 6000360, 6000361, 6000362, 6000364, 6000365, 6000366, 6000367, 6000368, 6000369, 6000370, 6000371, 6000372, 6000373, 6000375, 6000376, 6000377, 6000378, 6000379, 6000380, 6000381, 6000382, 6000383, 6000384, 6000385, 6000386, 6000387, 6000388, 6000389, 6000390, 6000392, 6340008, 11000021, 11000082, and 11000111. Class II Philips received reports from the field that the Flat Panel Detector (FPD) does not always remain securely latched in the stowed position. Philips Medical Systems (Cleveland) Inc
Devices Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-program Rechargeable Neurostimulator for Spinal Cord Stimulation. Medtronic implantable neurostimulation system is indicated for spinal cord stimulation (SCS) systems as an aid in the management of chronic, intractable pain of the trunk and/or limbs-including unilateral or bilateral pain associated with the following conditions: - Failed Back Syndrome (FBS) or low back syndrome or failed back - Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk - Postlaminectomy pain - Multiple back operations - Unsuccessful disk surgery - Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions - Peripheral causalgia - Epidural fibrosis - Arachnoiditis or lumbar adhesive arachnoiditis - Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia all serial numbers Class II Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Medtronic neurostimulators. Upon a specific set of conditions, typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended. Medtronic Neuromodulation
Devices Medtronic Activa PC, model 37601, and Activa RC, model 37612, Multi-program Rechargeable Neurostimulator for Deep Brain Stimulation. Medtronic Activa RC and Activa PC Deep Brain Stimulators are indicated for Therapy for Parkinson's Disease - Bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. Activa PC Deep Brain Stimulator is indicated for Therapy for Dystonia. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN). Indicated as an aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and segmental dystonia, hemidystonia, and cervical dystonia (torticollis), for individuals 7 years of age and older. Activa PC Deep Brain Stimulator is indicated for Obsessive-Compulsive Disorder. Bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive-compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs) all serial numbers Class II Medtronic notified customers regarding over stimulation or stimulation in the wrong area related to select Medtronic neurostimulators. Upon a specific set of conditions, typically related to device recovery from an over discharge, there is a potential for over stimulation or stimulation directed to a lead electrode other than what was intended. Medtronic Neuromodulation
Food Pringles(R) SALT & VINEGAR Potato Chips, 168 g (UPC 064100852464) and 181 g (UPC 037000230090), Pringles Manufacturing Company, 1306 Highway 70 Bypass, Jackson, TN, USA 38301-5072 All lot codes and best before dates currently on shelf of the following product, where milk is not declared on the list of ingredients Class II There was a change in Canadian labeling regulations where lactose was no longer sufficient, the label needed to stated "contains milk" Kellogg Canada Corporate Office
Devices Cordis OPTEASE Vena Cava Filter Is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the vena cava in the following situations: - Pulmonary thromboembolism when anticoagulants are contraindicated, - Failure of anticoagulant therapy for thromboembolitic disease, - Emergency treatment following massive pulmonary embolism where anticipate benefits of conventional therapy are reduce, and - Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated. 15277209 15414364 15560257 15752429 15287302 15550200 15282988 15421769 15565526 15753478 15291145 15566741 15287301 15424883 15568635 15755303 15307389 15570058 15290545 15430268 15572971 15761315 15311637 15582190 15291146 15435116 15579473 15767566 15325508 15593534 15296278 15437943 15581926 15777997 15343213 15612686 15300299 15444314 15585734 15781096 15355694 15627268 15300995 15448466 15591471 15789723 15369568 15638012 15307390 15450171 15593533 15793939 15381573 15652041 15307999 15454044 15598216 15799364 15402503 15670744 15312441 15456163 15605008 15802178 15406808 15686286 15317387 15460104 15606053 15809353 15430934 15699350 15320551 15466748 15610330 15812239 15435039 15737306 15325507 15471008 15614689 15816462 15444313 15762046 15330287 15473247 15627966 15822489 15462543 15768649 15335203 15478342 15632159 15830469 15466749 15793940 15340786 15480569 15632931 15836564 15473249 15798681 15344590 15487383 15637332 15839559 15481997 15814435 15350806 15490348 15643482 15843764 15495653 15820539 15353473 15495652 15647053 15848940 15506862 15845139 15358769 15501261 15652040 15855704 15525423 15854729 15366482 15501864 15656567 15857848 15543607 15860770 15370260 15505204 15659250 15863068 15375958 15513357 15667702 15870135 15380088 15518418 15670742 15875172 15385970 15522427 15675940 15878645 15386960 15526913 15683409 15884283 15386963 15529312 15690240 15896484 15389049 15530028 15694650 15918862 15391340 15535323 15698900 15925083 15396804 15538438 15704985 15932575 15400773 15544128 15707198 15932586 15406817 15546019 15736818 15950327 15408669 15551821 15742478 15961621 15409489 15556617 15747949 Class II Cordis identified a printing error on one unit of the Optease Vena Cava Filter, in which the orientation arrow for the femoral approach was printed in the incorrect direction. The error resulted in the filter being implanted upside down, requiring and additional percutaneous procedure to retrieve the filter. Cordis Corporation
Food the Snack Artist BBQ Flavored Potato Chips, Net Wt. 10 oz. (283 g), UPC 21130-29106. Distributed by Safeway, Inc. Pleasanton, CA 94566 Best By 08JAN2014 3255M27 Class I Undeclared Milk. BBQ flavored potato chip bags inadvertently contain Sour Cream & Onion flavored potato chips, which contain milk. Barrel O' Fun Snack Foods Co.
Food Western Nut Salt Lake City Roasted and Salted Inshell Peanuts, 6 oz (170g). Packaged in OPP (oriented polypropylene) bags. Receive bulk roasted/salted inshell peanuts from US Foods in 25 lb lined cases. Manufactured by Hampton Farms, Portales, NM for Western Nut. Lot #20013P1 Class II Western Nut is recalling certain lots of Roasted/Salted Inshell Peanuts due to unacceptable levels of Aflatoxin. Western Nut Company, Inc.
Devices Single Site Bipolar Maryland Forceps Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port. 2. Model number 428080-04 All distribution from 3-15-13 to 7-19-13. Batch/Lot # S10130510 S10130325 S10130314 S10130314 S10130415 S10130426 S10130329 S10130228 S10130418 S10130304 S10130418 S10130325 S10130325 S10130408 S10130408 S10130510 S10130415 S10130304 S10130314 S10130415 S10130418 S10130228 S10130329 S10130329 S10130415 S10130426 S10130426 S10130426 S10130408 S10130325 S10130228 S10130325 S10130426 S10130426 S10130418 S10130325 S10130510 S10130408 S10130415 S10130408 S10130228 S10130304 S10130418 S10130415 S10130426 S10130314 S10130426 S10130418 S10130228 S10130228 S10130304 S10130415 S10130415 S10130418 S10130408 S10130329 S10130314 S10130228 S10130228 S10130314 S10130325 S10130415 S10130426 Batch/Lot # S10130426 S10130418 S10130408 S10130325 S10130415 S10130415 S10130415 S10130418 S10130325 S10130325 S10130329 S10130325 S10130314 S10130329 S10130426 S10130314 S10130408 S10130329 S10130426 S10130426 S10130325 S10130415 S10130426 S10130426 S10130325 S10130325 S10130325 S10130329 S10130329 S10130408 S10130415 S10130408 S10130408 S10130415 S10130415 S10130418 S10130426 S10130415 S10130325 S10130408 S10130418 Class II A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication, warnings and precautions. Intuitive Surgical, Inc.
Devices Single Site Curved Needed Driver Intuitive Surgical, Sunnyvale, CA. 94086 The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with the da Vinci Si Surgical System (IS3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port. Model number 428088-12 All distribution from 3-15-13 to 7-19-13. Batch/Lot # S10130521 S10130405 S10130401 S10130405 S10130405 S10130521 S10130405 S10130405 S10130406 S10130406 S10130411 S10130411 S10130613 S10130405 S10130327 S10130327 S10130319 S10130319 S10130626 S10130703 S10130405 S10130319 S10130521 S10130613 S10130502 S10130405 S10130401 S10130406 S10130521 S10130613 S10130502 S10130406 S10130411 S10130405 S10130327 S10130412 S10130613 S10130314 S10130411 S10130327 S10130327 S10130411 S10130406 S10130613 S10130626 S10130412 S10130521 S10130405 S10130405 S10130314 S10130401 S10130411 S10130626 S10130703 S10130703 S10130703 S10130626 S10130613 S10130502 S10130401 S10130412 S10130406 Batch/Lot # S10130412 S10130405 S10130412 S10130314 S10130319 S10130502 S10130613 S10130405 S10130314 S10130405 S10130405 S10130613 S10130709 S10130703 S10130314 S10130319 S10130319 S10130314 S10130412 S10130521 S10130626 S10130411 S10130405 S10130521 S10130405 S10130319 S10130319 S10130319 S10130405 S10130405 S10130405 S10130314 S10130314 S10130314 S10130314 S10130319 S10130319 S10130319 S10130319 S10130314 S10130314 S10130314 S10130405 S10130327 S10130327 S10130405 S10130405 S10130412 S10130405 S10130327 S10130406 S10130406 S10130406 S10130613 S10130502 S10130613 S10130502 S10130521 S10130502 S10130613 S10130411 S10130502 Batch/Lot # S10130412 S10130521 S10130521 S10130521 S10130521 S10130613 S10130521 S10130405 S10130401 S10130405 S10130405 S10130613 S10130613 S10130703 S10130703 S10130319 S10130319 S10130626 S10130703 S10130405 S10130405 S10130405 S10130405 S10130521 S10130521 S10130405 S10130327 S10130406 S10130412 S10130412 S10130411 S10130401 S10130405 S10130521 S10130502 S10130406 S10130613 S10130411 S10130613 S10130613 S10130405 S10130401 S10130327 S10130405 S10130406 S10130405 S10130405 S10130405 S10130319 S10130319 S10130406 S10130406 S10130703 S10130613 S10130502 S10130412 S10130412 S10130406 S10130406 S10130521 S10130626 S10130405 S10130401 S10130412 S10130405 S10130405 S10130613 S10130502 Class II A limited number of FDA-cleared instruments for da Vinci Single Site use, Bipolar Maryland and curved needle Driver, were shipped without the correct revision of the user manual which provided added instruction for use of these additional Single Site instruments including indication, warnings and precautions. Intuitive Surgical, Inc.
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