APRIL 2009

WEEK ENDING APRIL 25

PRODUCT
a) 8 Fr 30cc Narrow Flex IAB Catheter Kit with Generica Adapters Product Number: IAB-04830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, 
 
b) 8 Fr 40cc Narrow Flex IAB Catheter Kit with Generic Adapters Product Number: IAB-04840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle.
 
c) 8 Fr 30cc Ultra 8 IAB, IAB-05830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, 
 
d) 8 Fr 40cc Ultra 8 IAB, IAB-05840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, 
 
e) 7.5 Fr 30cc UltraFlex IAB, IAB-06830-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle;
 
f) 7.5 Fr 40cc UltraFlex IAB, IAB-06840-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, 
 
g) 8 Fr 30cc FIBEROPTIX IAB, IAB-05830-LWS, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, 
 
h) 8 Fr 40cc FIBEROPTIX IAB, IAB-05840-LWS, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle,
 
i) 7 FR 30CC Rediguard IAB, IAB-S730C, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, ;
 
j) 8 FR 40CC Rediguard IAB, IAB-S840C, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, 
 
k) 9 FR 50CC Rediguard IAB, IAB-R950-U, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, 
 
l) ARROW 40cc Drive Line Kits, REF IAK-02692, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle., 
 
m) ARROW 50cc Drive Line Kits, REF IAK-02693, Intra-aortic balloon catheter. The Intra-aortic balloon (IAB) is utilized for IAB counter-pulsation therapy, whereby balloon inflation in the aorta during diastole and deflation during systole increase blood supply to the heart muscle and decrease work of the left ventricle, 
CODE
a) Lot /Serial Numbers: MF6079580 MF6100954 MF7033668 MF7086558 MF7086984 MF7097225 MF7097426 MF7118000 MF7118001 MF7128557 and MF8018922;
 
b) Lot/Serial Numbers: MF6090318 MF6111511 MF7065955 MF7076255 MF7086556 MF7097114 MF7097115 MF7097226 MF7097227 MF7097228 MF7097427 MF7097470 MF7097471 MF7107861 MF7107862 MF7118045 MF7118046 MF7128470 MF7128508 MF8018724 MF8018813 MF8018996 MF8124303 MF8124304 MF9014426 MF9014444 MF9014446 and MF9014447;
 
c) Lot/Serial Numbers: MF6122058 MF7065640 MF7076257 MF7076378 MF7097392 MF7118003 MF7118004 MF7118219 MF7128387 MF7128471 MF7128504 MF7128505 MF8018907 MF8018997 MF8030122 MF8039664 MF8039878 MF8040324 MF8040325 MF8040638 MF8050911 MF8061125 MF8061176 MF8061334 MF8061500 MF8061615 MF8071782 MF8072074 MF8082267 MF8082584 MF8092783 MF8092784 MF8093000 MF8093001 MF8103155 MF8103262 MF8103263 MF8124064 MF8124178 MF8124064 MF8124307 and MF8124408;
 
d) Lot/Serial Numbers: MF7065606 MF7076012 MF7076021 MF7086462 MF7086736 MF7107536 MF7107537 MF7107694 MF7107696 MF7118048 MF7118049 MF7118050 MF7118151 MF7118221 MF7118222 MF7128472 MF7128506 MF7128507 MF8018908 MF8019033 MF8019034 MF8019035 MF8019104 MF8029191 MF8029433 MF8029434 MF8039774 MF8040251 MF8040287 MF8050764 MF8050812 MF8050966 MF8061267 MF8061413 MF8071676 MF8071863 MF8082268 MF8082507 MF8093002 MF8103280 MF8103416 MF8103571 MF8113836 MF8113919 MF8113951 and MF8124345;
 
e) Lot/Serial Numbers: MF8039760 MF8039772 MF8040252 MF8040485 MF8040486 MF8040639 MF8050723 MF8050807 MF8050914 MF8061336 MF8061458 MF8061616 MF8061617 MF8071677 MF8071855 MF8082154 MF8082586 MF8092763 MF8093004 MF8103159 MF8103160 MF8103264 MF8103265 MF8103417 MF8124181 MF8124203 MF8124413 and MF8124414;
 
f) Lot/Serial Numbers: MF8029428 MF8029506 MF8029508 MF8030125 MF8030126 MF8039646 MF8039647 MF8039762 MF8039851 MF8040487 MF8040640 MF8050724 MF8061127 MF8061503 MF8071787 MF8072071 MF8082286 MF8082508 MF8093047 MF8103162 MF8103418 MF8103642 MF8113920 MF8114010 MF8124162 and MF8124162;
 
g) Lot/Serial Numbers: MF6090321 MF6122057 MF7044419 MF7076250 MF7086674 MF7107863 MF7118002 MF7128359 MF7128561 MF8018727 MF8018849 MF8019095 MF8039848 MF8039849 MF8039991 MF8040484 MF8050805 MF8050981 MF8061206 MF8061268 MF8061335 MF8061416 MF8072073 MF8082285 MF8082394 MF8082505 MF8082506 MF8092785 MF8092999 MF8103156 MF8113922 MF8114009 MF8124160 MF8124308 and MF8124409;
 
h) Lot/Serial Numbers: MF7044497 MF7054982 MF7076013 MF7086515 MF7086964 MF7097339 MF7097388 MF7107535 MF7128358 MF7128419 MF7128466 MF8018705 MF8018706 MF8018707 MF8018725 MF8018726 MF8018729 MF8018846 MF8018847 MF8018848 MF8018924 MF8018925 MF8018998 MF8018999 MF8019101 MF8019102 MF8029111 MF8029166 MF8029167 MF8029168 MF8029256 MF8029257 MF8029258 MF8039704 MF8039705 MF8039706 MF8039707 MF8039709 MF8040286 MF8040326 MF8040543 MF8040641 MF8050720 MF8050721 MF8050722 MF8050806 MF8050912 MF8050913 MF8050982 MF8050995 MF8050996 MF8061126 MF8061177 MF8061185 MF8061405 MF8061406 MF8061457 MF8061501 MF8071783 MF8071784 MF8071785 MF8071786 MF8071853 MF8071854 MF8071864 MF8072072 MF8082151 MF8082395 MF8082396 MF8082397 MF8092764 MF8092786 MF8093003 MF8103157 MF8103158 MF8103640 MF8113837 MF8113838 MF8113839 MF8113840 MF8113949 MF8113950 MF8124161 MF8124179 MF8124202 MF8124179 MF8124202 MF8124309 MF8124340 MF8124410 and MF8124411;
 
i) Lot/Serial Numbers: MF7012650 MF7065398 MF7076011 MF7086585 MF7086981 MF7097060 MF7097473 MF7107623 MF7117871 MF7128553 MF8018756 MF8018814 MF8019001 MF8019036 MF8029114 MF8029190 MF8039773 MF8039989 MF8040133 MF8050762 MF8050763 MF8050985 MF8051093 MF8061455 MF8071620 MF8082323 MF8082324 MF8082325 MF8092832 MF8103260 MF8124197 MF8124198 and MF8124282;
 
j) Lot/Serial Numbers: MF6090326 MF6101289 MF7012817 MF7065399 MF7065882 MF7076380 MF7086744 MF7097061 MF7097113 MF7097319 MF7097474 MF7118038 MF7118039 MF7128469 MF7128554 MF7128555 MF7128556 MF8018842 MF8018976 MF8019000 MF8019100 MF8029244 MF8029295 MF8029296 MF8029509 MF8039793 MF8039794 MF8039988 MF8040431 MF8040432 MF8040433 MF8040445 MF8040601 MF8040602 MF8040603 MF8050760 MF8050761 MF8050986 MF8050987 MF8050988 MF8051091 MF8051092 MF8061324 MF8061325 MF8061456 MF8071619 MF8071627 MF8071628 MF8071789 MF8071849 MF8072043 MF8082319 MF8082320 MF8082321 MF8082322 MF8092737 MF8092833 MF8092870 MF8092871 MF8092872 MF8092873 MF8103163 MF8103164 MF8103165 MF8103166 MF8103167 MF8103168 MF8103568 MF8103569 and MF8103165;
 
k) Lot/Serial Numbers: MF7076413 MF7086743 MF7097191 MF8092738 MR8039844 and MF8124297;
 
l) Lot/Serial Numbers: MF8082119 MF8092600 MF8103515 and MF8113761;
 
m) Lot/Serial Number: MF8082120
RECALLING FIRM/MANUFACTURER Arrow International, Inc., Everett ,  MA ,
REASON A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.
VOLUME OF PRODUCT IN COMMERCE 61,778 total units
DISTRIBUTION Nationwide and Argentina , Australia , Taiwan , Singapore , New Zealand , India , Brazil , Belgium , Korea , Peru , Finland , and Denmark

PRODUCT Stryker Trio Small Offset Connector Non Sterile; The Trio Spinal Fixation Systems are pedicle screws systems intended for use in providing immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic lumbar, and sacral spine: degenerative spondyolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion. Catalog Number 48902015
CODE Lot codes: 056254, 056255, 056256, 056257, 56258, 056259, 058065, 05A140, 05A142, 058066, 05A139, 05A141, 058915, 05A143, 05A145, 05A146, 05A144, 061075, 061077, 061551, 061072, 061076, 0615550, 061549, 061760, 05A148, 05A149, and 05A147
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Spine, Allendale , NJ , 
Manufacturer: Stryker Spine, Cestas, France . .
REASON Reports were received of the ball ring ejecting from the connector's body when other connectors have already been locked down.
VOLUME OF PRODUCT IN COMMERCE 2,417 units
DISTRIBUTION Nationwide

PRODUCT CADD Medication Cassette Reservoir 100 ml with Clamp and Female Leur, Nonvented stopper included REF 21-7002-24, Sterile EO. CADD Medication Cassette Reservoirs are intended for use with the CADD Ambulatory Infusion Pumps used for delivering drug therapy and anesthesia to patients. The pumps can be used by home care patients and in a healthcare facility,
CODE Lot Numbers: 213X18 and 214X18
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smiths Medical MD, Inc., Saint Paul ,  MN , 
Manufacturer: Smiths Healthcare Manufacturing S.A. De C.V., Tijuana BC , Mexico . 
REASON Smiths Medical noticed an increased trend in leakage associated with 100 ml CADD Medication Cassette Reservoirs. If a leak occurs in a CADD medication Cassette Reservoir, it may allow spillage of medication, contamination of the fluid path, and/or air to enter the Reservoir. Smiths Medical has not received any report of patient injuries due to these leakages.
VOLUME OF PRODUCT IN COMMERCE 17,868 cassettes ( 1,489 boxes 12 cassettes/box)
DISTRIBUTION PA and countries of El Salvador , Australia , France , Finland , Sweden , and Germany

PRODUCT
a) Deltec Cozmo Insulin Pump, Model 1800. Deltec Cozmo Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is used mainly by homecare patients but, can also be used in a healthcare facility, 
 
b) Deltec Cozmo Insulin Pump, Model 1700 containing 1800 software. Deltec Cozmo Insulin Pumps are ambulatory electromechanical pumps used for delivering insulin to patients with diabetes. The pump is used mainly by homecare patients, but can also be used in a healthcare facility, CODE
a) Product Numbers: 21-1801-51 21-1801-81 21-1803-51 21-1803-81 21-1804-51 21-1804-81 21-1805-137 21-1805-138 21-1805-29 21-1805-49 21-1805-51 21-1805-81 21-1806-137 21-1806-138 21-1806-29 21-1806-49 21-1806-51 21-1806-81 21-1807-137 21-1807-138 21-1807-29 21-1807-49 21-1807-51 21-1807-81 21-1815-01 21-1815-135 21-1815-50 21-1816-01 21-1816-135 21-1816-50 21-1817-01 21-1817-135 21-1817-50 21-1825-81 21-1826-81 and 21-1827-81;
 
b) Product Numbers: 21-1705-79 21-1705-89 21-1706-79 21-1706-89 21-1707-79 21-1707-89 21-1715-19 21-1716-19 and 21-1717-19
RECALLING FIRM/MANUFACTURER Smiths Medical MD, Inc., Saint Paul , MN , 
REASON There have been adverse events reported that the amount of Extended Bolus delivered was not accurately displayed by the Pump. The amount of extended Bolus displayed on the Pump Home Screen 2 and in the Bolus Summary Report is less than what was programmed by the user. In these events, the Pumps delivered the correct amount of insulin as programmed by the user. If the user programs an additional Bolus based solely on the extended Bolus delivered amount displayed on the Bolus Summary Report or Home Screen 2, there is a risk of hypoglycemia.
VOLUME OF PRODUCT IN COMMERCE 17,047 units
DISTRIBUTION Nationwide and countries of Australia, New Zealand, United Kingdom, Ireland, Canada, China, Greece, Poland, Slovenia, Sweden, Israel and Brazil

PRODUCT
a) GE Healthcare Infinia, Model Numbers: a) ASM000886, b) ASM001333, c) ASM001391, d) ASM001465, e) ASM001473, f) ASM001620, g) ASM500016, h) H3000WM, i) H3000WT, j) H3000WY and k) SYS000041. Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, 
 
b) GE Healthcare Infinia Hawkeye, Model Numbers: a) H3000WR, b) H3000WW, c) H3000WZ, d) H3000YM and e) H3000YS. Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, 
 
c) GE Healthcare Infinia Hawkeye 4, Model Numbers: a) 5178728, b) ASM500060, c) H3000WC and d) H3000WD. Product is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, 
CODE
a) Lot Numbers: 16017 16004 16007 16012 16006 16008 16010 16023 16039 16026 16025 16015 16052 16022 16055 16065 16027 16142 16084 16101 16030 16054 16079 16042 16064 16062 16109 16060 16100 16097 16129 16125 16130 16160 16110 16136 16151 16161 16145 16184 16173 16156 16080 16178 16126 16113 16096 16107 16170 16003 16059 17049 17029 17061 17050 17052 17046 17029 17068 and 17154;
b) Lot Numbers: 16001 16049 16043 16040 16028 16009 16051 16053 16044 16037 16015 16099 16035 16048 16020 16053 16013 16026 16036 and 16014; c) Lot Numbers: 16063 16076 16073 16102 16106 16088 16075 16122 16124 16074 16120 16083 16149 16152 16056 16150 16153 16105 16162 16182 16163 16166 16188 16132 16058 16167 16131 16216 16168 16217 16221 16179 16164 16094 16169 16187 16090 16172 16177 16175 16093 16183 16186 16091 16246 16238 16041 16174 16104 16050 16073 16140 16078 16139 16158 and 16067; d) Lot Numbers: 16195 16192 16205 16198 16212 16219 16210 16206 16193 16227 16270 16273 16203 16267 16281 16288 16200 16313 16342 16294 16330 16286 16303 16327 16299 16332 16243 16252 16333 16290 16364 16360 16339 16335 16344 16245 16381 16385 16176 16377 16362 16366 16388 16320 16334 16399 16384 16380 16412 16413 16411 16236 16369 16432 16428 16289 16404 16405 16408 16256 16414 16429 16365 16427 16433 16394 16343 16230 16441 16426 16443 16435 16439 16470 16471 16391 16223 16466 16475 16376 16464 16455 16511 16349 16510 16514 16515 16500 16532 16451 16538 16493 16533 16537 16547 16487 16395 16482 16505 16528 16517 16549 16560 16529 16508 16520 16564 16445 16438 16476 16278 16378 16347 16211 16415 and 16421; e) Lot Numbers: 16254 16276 16316 16314 16308 16283 16323 16298 16326 16284 16280 16262 16345 16331 16291 16337 16312 16352 16371 16346 16355 16368 16315 16356 16266 16379 16410 16398 16321 16416 16293 16340 16374 16429 16318 16406 16420 16319 16456 16440 16450 16449 16477 16460 16329 16302 16492 16474 16448 16499 16498 16490 16478 16430 16494 16496 16309 16400 16491 16452 16419 16328 16397 16462 16191 16418 and 16495; f) Lot Numbers: 16581 16574 16592 16645 16632 16622 16611 16661 16668 16595 16625 16587 16656 16708 16629 16638 16566 16663 16617 16694 16721 16692 16673 16742 16702 16738 16675 16745 16725 16715 16719 16688 16613 16726 16704 16714 16777 16674 16776 16805 16645 16770 16782 16759 16791 16837 16798 16836 16830 16842 16766 16853 16616 16577 16847 16835 16857 16851 16860 16824 16858 16834 16653 16818 16894 16752 16736 16883 16655 16870 16875 16896 16594 16902 16801 16868 16881 16909 16943 16897 16941 16939 16942 16819 16867 16810 16877 16940 16890 16839 16980 16668 16989 16740 16717 16956 16997 17083 16923 17022 16996 16705 17039 and 16695; g) Lot Numbers: 16501 16522 16534 16535 16576 16575 16553 16516 16506 16562 16557 16542 16541 16551 16602 16573 16614 16583 16586 16571 16607 16569 16578 16621 16649 16635 16669 16593 16639 16647 16681 16660 16580 16684 16679 16677 16686 16646 16657 16667 16637 16693 16699 16689 16665 16654 16676 16666 16697 16718 16610 16701 16563 16716 16579 16424 16710 16698 16707 16733 16747 16584 16706 16709 16765 16239 16605 16725 16741 16768 16749 16751 16779 16746 16750 16792 16773 16536 16780 16790 16769 16600 16797 16814 16817 16807 16802 16601 16690 17030 and 16815; h) Lot Number: 16353; i) Lot Numbers: 16115 16207 16224 16229 16220 16208 16235 16244 16234 16250 16279 16295 16269 16301 16285 16293 16324 16255 16271 16370 16233 16372 16422 16442 16382 16437 16453 16425 16457 16454 16465 16259 16469 16509 16519 16497 16527 16479 16531 16524 16434 16489 16567 16539 16502 16446 16311 16627 16640 16608 16636 16641 16634 16540 16659 16628 16643 16658 16209 16228 16685 16626 16513 16548 16664 16672 16559 16670 16662 16720 16696 16734 16713 16763 16735 16748 16761 16767 16775 16803 16762 16536 16783 16812 16310 16392 16731 16788 16728 16723 16214 16504 16799 16502 16249 16503 16756 16760 16680 16376 16518 16612 16525 16300 16297 16447 16732 16786 16710 16758 16786 16731 16213 16808 16804 16135 16848 16800 16833 16816 16806 16789 16822 16841 16840 16839 16829 16832 16437 16587 16866 16861 16863 16825 16900 16916 16872 16882 16908 16917 16772 16929 16935 16920 16778 16959 16964 16196 16263 16305 16913 16526 16648 16796 16991 16912 17003 17031 17006 17056 17012 16971 16983 16851 17009 17027 17073 17014 17074 17064 17043 17117 17080 17155 17059 17142 17160 17152 17123 16296 16904 17146 17212 17177 17216 17218 17015 17223 16993 16218 17184 17234 17246 17275 17282 17274 17257 17279 17291 17134 17270 17196 17308 17302 17230 16984 17261 17334 17355 17315 17242 17168 17283 16973 17378 17371 17380 17393 17409 17396 17292 17221 17186 and 16483; j) Lot Numbers: 16282 16204 16423 16143 16423 and 17085 and k) Lot Numbers: 16005 16034 16018 16045 16092 16016 16123 16098 16072 16084 16111 16136 16108 16155 16116 16180 16189 16185 and 16137;
 
b) a) Lot Numbers: 16306 and 16275; b) Lot Numbers: 16086 16202 16231 16241 16268 16265 16247 16277 16201 16272 16274 16258 16278 16242 16257 16341 16307 16232 16351 16358 16363 16383 16134 16383 16367 16095 16359 16338 16390 16407 16253 16463 16242 16461 16484 16467 16472 16486 16393 16488 16507 16545 16459 16546 16523 16550 16521 16402 16417 16599 16556 16480 16558 16597 16555 16590 16603 16598 16606 16618 16630 16596 16530 16619 16609 16631 16623 16691 16708 16620 16633 16642 16599 16703 16591 16671 16764 16757 16604 16787 16615 16287 16690 16568 16458 16711 16727 16386 16729 16444 16260 16678 16687 16588 16700 16653 16730 16782 16824 16342 16879 16003 16801 16884 16292 16906 16892 16931 16952 16954 16222 16936 16895 16257 16951 16373 16958 16389 16982 16981 17038 16754 16985 16998 16855 16458 16644 and 16544; c) Lot Numbers: 16237 16350 16251 16375 16387 16512 16565 16582 16403 16240 16183 16572 16485 16552 16248 16215 16261 16197 16468 16361 16624 16813 16409 16831 16481 16240 16264 16891 16961 16826 and 17148; d) Lot Numbers: 16046 16011 16021 16057 16027 16128 16077 16097 16019 16103 16082 16112 16029 16121 16157 16148 16159 16038 16147 16146 16127 16154 16174 16024 and 16133 and e) Lot Numbers: 16068 16089 16141 16085 and 16061;
 
c) a) Lot Numbers: 17445 17001 17035 17023 17008 16988 17007 17010 17063 17077 17053 16995 17088 17098 17090 16990 17054 17099 17081 17060 17128 17140 17116 17004 17089 17036 17045 17129 17130 17108 17093 17171 17144 17158 17069 17135 17040 17172 17132 17183 17153 17201 17182 17111 17190 17187 17175 17169 17133 17213 17166 17104 17203 17141 17204 17139 17113 17224 17226 17228 17210 17229 17119 17255 17239 17233 17002 17266 17245 17276 17264 17248 17094 17256 17273 17254 17281 17294 17305 17277 17250 17252 17287 17307 17325 17285 17317 17288 17272 17299 17220 17321 17329 17341 17314 17293 17335 17328 17286 17366 17350 17306 17342 17096 17365 17309 17364 17349 17339 17369 17300 17390 17387 17361 17394 17376 17403 17359 17437 17415 17389 17382 17435 17423 17304 17449 17297 and 17241; b) Lot Numbers: 16821 16820 16846 16865 16852 16862 16880 16774 16893 16888 16874 16924 16928 16927 16933 16926 16937 16934 16938 16844 16930 16969 16962 16963 16977 16925 16901 16945 17005 16986 16914 17020 16944 16885 17034 17019 16949 17057 17055 17058 16976 16965 16976 17047 16987 and 17070;
c) Lot Numbers: 16838 16849 16856 16850 16876 16869 16878 16811 16871 16889 16905 16898 16911 16921 16922 16910 16932 16886 16974 16955 16887 16919 16978 16968 16947 16979 16967 16972 16966 16970 17011 16994 17024 16950 17048 17042 17062 17018 17082 17105 17106 17000 17100 17125 17121 17025 17136 17122 17118 17041 17131 17103 17174 17164 17109 17197 17101 17114 16960 17199 17198 17124 17195 17179 17112 17185 17219 17238 17178 17247 17173 17265 16975 17259 17298 17260 17301 17278 17231 17165 17289 17290 17295 17333 17251 17338 17337 16946 17348 17373 17363 17347 17323 17326 17430 17416 17429 17415 17208 17422 17450 17258 and 17249; and d) Lot Numbers: 17072 17126 17067 17107 17163 17236 17346 and 17379
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesha , WI , 
Manufacturer: GE Medical System, Tirat Hacarmel   30200 , Israel . 
REASON GE Healthcare has recently become aware of excessive pressure applied by the collimator pressure sensitive cover of Infinia (Infinia, Infinia Hawkeye, Infinia Hawkeye 4) that may impact patient safety. It was reported at a customer site that the pressure used to activate the Pressure Sensitive Device (PSD) should be lowered and that the body contouring software requires correction to prevent possible patient injury during operation. This resulted in a patient receiving a broken nose during a whole body scan while using the Auto Body Contour software option.
VOLUME OF PRODUCT IN COMMERCE 1,256 units
DISTRIBUTION
AL, AK, AZ, AR, CA, CO, CT, DE, DC, FL, GA, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, PR, SC, SD, TN, TX, UT, VT, VA, WA, WV and WI and countries of Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech, Denmark, Ecuador, Egypt, Finland, France, Germany, Greece, Hungry, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Republic of Georgia, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine and the United Kingdom

PRODUCT Reflection, Microstable Acetabular Liner, REF 71740250, 32mm ID, 50-52 OD, 1 each, sterile EO. Component is a liner used to hold the femoral head used in total hip replacement arthroplasty procedures, 
CODE Lot Numbers: 08FM05400 and 08FM05400B
RECALLING FIRM/MANUFACTURER Smith & Nephew Inc., Memphis ,  TN ,
REASON Liners measuring 28 mm ID and were mismarked as 32 mm.
VOLUME OF PRODUCT IN COMMERCE 19 units
DISTRIBUTION Canada , France , Germany and Switzerland

PRODUCT
a) AxSYM HBsAg Reagent Pack; AxSYM HBsAg is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of hepatitis B surface antigen (HBsAg) in neonatal serum, and adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium EDTA, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes); list 9B01-20, 
 
b) AxSYM CMV IgG Reagent Pack; The AxSYM CMV IgG assay is a Microparticle Enzyme Immunoassay (MEIA) for the semi-quantitative measurement of IgG antibodies to cytomegalovirus in human serum and plasma (EDTA, heparin or sodium citrate) as an indication of past or current infection with cytomegalovirus; list 4B47-20, 
 
c) AxSYM CORE 2.0 Reagent Pack; Abbott Laboratories, Abbott Park, IL 60064; AxSYM CORE 2.0 is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of total antibodies (IgG and IgM) to hepatitis B virus core antigen (anti-HBc) in adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium EDTA, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes containing lithium heparin); list 8B88-20, 
 
d) AxSYM Folate Reagent Pack; AxSYM Folate is an ion capture assay for the quantitative determination of folate in human serum, plasma or red blood cells on the AxSYM System; list 3C81-20,
 
e) AxSYM Myoglobin Reagent Pack; AxSYM Myoglobin is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of myoglobin in human serum or plasma on the AxSYM System; list 3E43-20, ;
 
f) AxSYM Troponin-I ADV Reagent Pack; AxSYM Troponin-I ADV is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative determination of cardiac troponin-I (cTnI) in human serum or plasma on the AxSYM System; list 2J44-22, 
CODE
a) Lot Number: 66495M100;
b) Lot Number: 66577M100;
c) Lot Number: 66253M200;
d) Lot Number: 68537M100;
e) Lot Number: 63493M200;
f) Lot Numbers: 67320M100 and 67320M101;
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Abbott Park , IL 
REASON Defective caps; Customers have observed reagent bottles not opening appropriately, which could lead to a probe crash on the instrument.
VOLUME OF PRODUCT IN COMMERCE 10,123 kits
DISTRIBUTION Nationwide, Germany , Mexico , Hong Kong, and Japan

PRODUCT
a) AxSOS T8 Screwdriver, 3.0mm Locking Set; REF 702746. This product is non sterile. The screwdrivers of the AxSOS system are multiple use instruments used to insert screws into bones, 
 
b) AxSOS Torque Limiting Screwdriver, T8 1.5 Nm 3.0mm Locking Set; REF 702749. This product is non sterile. The torque limiter is used for final tightening locking screws to the plate in order to avoid over tightening of the locking screws, 
CODE All lot codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah , NJ 
Manufacturer: Stryker Trauma AG, Selzach , Switzerland .
REASON Potential for the tip of the AxSOS Screwdriver and the AxSOS Torque Limiter to break.
VOLUME OF PRODUCT IN COMMERCE 882 units
DISTRIBUTION Nationwide

PRODUCT
a) ALM Prismatic Surgical Light 9551 DF; Maquet SA. ALM Prismatic (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures; Article Number: 567014999, 
 
b) ALM Prismatic Surgical Light 54004 SF; Maquet SA. ALM Prismatic (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is designed to eliminate shadow, reduce reflected heat, and illuminate surgical incisions of all depths during surgical procedures; Article Number: 567030999, 
CODE
a) Serial Numbers: 1104, 1105, 1106, 25163, 25340, 25341, 25890, 26012, 26417, 26418, 26686, 27251, 27753, 27854, 27855, 28096, 28097, 28813, 29652, 29950, 30087, 30152, 30333-30334, 30739, 31250, 31381, 32333, 32334, 32336, 32580, 32708, 32709 and 32800;
 
b) Serial Numbers: 6041, 6042, 6043, 6044, 6045, 6046, 6047, 6048, 6049, 6050, 6051, 6052, 6053, 6054, 6057, 6058, 6059, 6060, 6061 and 6062
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maquet, Inc., Bridgewater , NJ , .
Manufacturer: Maquet S.A. , Orleans Cedex 2, France. 
REASON The screws holding the Prismatic triple surgical lights may break due to dynamic multidirectional bending stress. The firm has received one complaint report.
VOLUME OF PRODUCT IN COMMERCE 54 units
DISTRIBUTION Nationwide

PRODUCT NurseMate with Physio Module; Remote Review, Monitoring and Charting Station; Outer box labeled as Smiths Medical. The NurseMate Remote Review Station is an integrated review station for the EP WorkMate Computer recording system that allows a separate user to review and edit patient study date stored on the SP Work Mate System and monitor patient data from the EP WorkMate during a Patient study. Smith Medical Part Number: 87-1785-0000, 
CODE Serial Numbers: AM08080015, AM08080016, AM08080017, AM08080018, AM08080019, AM08100004, AM08100005, AM08100006, AM08100007 and AM08100008
RECALLING FIRM/MANUFACTURER
Recalling Firm: EP Medsystems, Inc., West Berlin , NJ ,
Manufacturer: Smiths Medical PM, Inc., Waukesha , WI . .
REASON There is a risk that the monitor may not be adequately secured to the stand, resulting in the monitor falling off which may cause injury.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION CA, NV, FL

PRODUCT Low-Level Output Cable. The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to be displayed on a separate patient monitor; Part Number: 0012-00-1589-03 Rev. C, 
CODE RAM 0827
RECALLING FIRM/MANUFACTURER Datascope Corp - Cardiac Assist Division, Mahwah ,  NJ 
REASON Non-functioning cable: the Low-Level Output Cable when connected to a Datascope Intra-aortic Balloon Pump (IABP) and patient monitor does not provide a signal to the patient monitor.
VOLUME OF PRODUCT IN COMMERCE 20 units
DISTRIBUTION IL, FL

PRODUCT 300 microliter CO-RE tips for use with Microlab STAR series instruments, Part Number 235902, 5,760 tips per case. The products are a disposable product that are used with the Microlab STAR series instruments, which are microliter diluting and dispensing devices
CODE Lot Number: 2873900
RECALLING FIRM/MANUFACTURER Hamilton Co., Reno ,  NV 
REASON Some tips may be occluded and are unable to aspirate or dispense liquid.
VOLUME OF PRODUCT IN COMMERCE 28 cases
DISTRIBUTION MA, CA, MN, CT, and NC

PRODUCT
a) Edwards Lifesciences Swan-Ganz Thermodilution Catheter REF: 139F75 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output, 
 
b) Edwards Lifesciences Swan-Ganz Intellicath CCO/VIP Thermodilution Catheter with AMC Thromboshield (an Antimicrobial *Heparin Coating) For use with Vigilance Monitor. REF: 139HF75 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output, 
 
c) Edwards Lifesciences Swan-Ganz Thermodilution Catheter with AMC Thromboshield (An Antimicrobial * Heparin Coating) REF: 139HF75P For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output, 
 
d) Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2 Thermodilution Catheter with AMC Thromboshield (an Antimicrobial * Heparin Coating); For use with Vigilance Monitor. This package contains: One catheter and one volume-limited syringe. REF: 744HF75 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output, ;
 
e) Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter For use with Vigilance Monitor. This package contains: One catheter and one volume-limited syringe. REF: 746F8; For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output, 
 
f) Edwards Lifesciences Swan-Ganz CCOombo CCO/SvO2/VIP Thermodilution Catheter with AMC Thromboshield (An Antimicrobial * Heparin Coating) For use with Vigilance Monitor. This package contains: One catheter and one volume-limited syringe. REF: 746HF8 For use inpatients who require hemodynamic monitoring. Intended to be used in combination with clinical pressure monitoring equipment to measure right heart and pulmonary artery pressures, and with the Vigilance Monitor to measure cardiac output, 
CODE
a) Lot number: 58619364 - expiration date between May 2010 and November 2010;
 
b) Lot number: 58619322 - expiration date between May 2010 and November 2010;
 
c) Lot numbers: 58612687, 58612688, 58614615, 58618629, 58618632, 58619700, 58619701, 58619702, 58621364, 58621568, 58623753, 58623754, 58627920, 58629865, 58632893, 58632895, 58644277, and 58644651;
 
d) Lot numbers: 58612694, 58612695, 58615354, 58615358, 58615361, 58618060, 58618061, 58618062, 58626669, 5862672, 58626679, 58626683, 58629859, 58630224, 58630225, 58630226, 58630227, 58635119, 58636668, 58644190, 58646593, 58646595, and 58646597;

e) Lot number: 58617326;
 
f) Lot numbers: 58612700, 58612702, 58617328, 58617329, 58617330, 58617332, 58617341, 58619706, 58619707, 58619708, 58619709, 58621527, 58621532, 58621535, 58623045, 58623047, 58625221, 58625549, 58627893, 58627899, 58629866, 58630228, 58631725, 58632892, 58633695, 58633696, 58636429, and 58644898
RECALLING FIRM/MANUFACTURER
Recalling Firm: Edwards Lifesciences, LLC, Irvine ,  CA , 
Manufacturer: Edwards Lifesciences Technology SARL, Anasco, PR. 
REASON Cardiac output measurements were unavailable and the following message is displayed in the Vigilance monitor: "Fault. CCO Catheter Verification. Use Bolus Mode".
VOLUME OF PRODUCT IN COMMERCE 10,754 units
DISTRIBUTION
AL, AR, AZ, CA, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, MT, NC, NE, NJ, NM, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY, Hawaii, and Puerto Rico and countries of Canada, Austria, Belgium, Switzerland, Germany, Denmark, Spain, Finland, France, UK, Greece, Ireland, Israel, Italy, Kuwait, Netherlands, Norway, Portugal, Sweden, Colombia, Australia, and Singapore

PRODUCT Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized with Ethylene Oxide. The ViperWire atherectomy guide wire has a shaft diameter of 0.014" and is constructed of stainless steel with a smooth finish and is silicone coated. The spring tip configuration is atraumatic, radiopaque, and can be bent to form a steerable system,
CODE Lot number: P1406641
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardiovascular Systems, Inc., Arden Hills , MN , 
Manufacturer: Lake Region Mfg., Inc., Chaska , MN . 
REASON Devices recalled due to a mislabeling of the shelf life as shown on the device labeling. The labeling shown on the affected devices represents a 24 month shelf life rather than a 6 month shelf life that should have been indicated.
VOLUME OF PRODUCT IN COMMERCE 10 devices
DISTRIBUTION Nationwide

PRODUCT Modular Replacement System (MRS) Cemented Stems, Sterile, Catalog Numbers: 6485-3-000, 6485-3-008, 6485-3-009, 6485-3-010, 6485-3-018, 6485-3-019, 6485-3-300, 6485-3-308, 6485-3-309, 6485-3-310, 6485-3-318, and 6485-3-319. The Modular Replacement System has been successfully used in clinical in clinical situations where there is extensive bone loss due to tumor resection, and/or failed previous prosthesis, or trauma. These components can be used to replace the proximal femur, the distal femur, the proximal tibia, or to reconstruct the total femur in extreme clinical situations, 
CODE All lots
RECALLING FIRM/MANUFACTURER Stryker Howmedica Osteonics, Corp., Mahwah , NJ
REASON Instruction for use incorrect: There are no statements or warning on labels or Instructions for Use that 8, 9 and 10 mm diameter MRS Cemented Stems are indicated only for use in the GMRS Proximal Tibial and Distal Femoral Components.
VOLUME OF PRODUCT IN COMMERCE 1,161 units
DISTRIBUTION Nationwide
 
PRODUCT Medtronic Streamline Bipolar Temporary Myocardial Pacing Lead, 6495, Sterile EO, REF 6495F, 
CODE Lot number: JDG880205F
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic, Inc., Minneapolis , MN , .
Manufacturer: Medtronics France, SA, Fourmies , France . 
REASON This lot of product contains incorrect inner pouch labeling; instead of 6495 it is labeled 6500. The outer carton, shelf box labeling, and instructions for use are correct, and the actual product shipped was consistent with the product ordered. No adverse patient effects have been reported.
VOLUME OF PRODUCT IN COMMERCE 612 units
DISTRIBUTION Nationwide

PRODUCT Pointe Scientific Direct Bilirubin Reagent Set. The device intended use is a clinical chemistry reagent for the in vitro, quantitative determination of direct bilirubin in serum on Hitachi analyzers. a) HB936-120, and b) HB936-294, 
CODE a) Lot Number: 731801, exp. 11/2011 and b) Lot Number: 817103, exp. 5/2012
RECALLING FIRM/MANUFACTURER Pointe Scientific, Inc., Canton   MI
REASON The product performance fails due to precipitation of the R2 component.
VOLUME OF PRODUCT IN COMMERCE 24 kits
DISTRIBUTION Nationwide, Chile and Mexico

PRODUCT Biomet Marrowstim Concentration Kit w/single Disposable Separator, Bone Marrow Needle, and 30 ml ACD-A. For use with BBI centrifuges only, sterile; REF 800-0611A and 800-0613A. The device is used for the rapid preparation of platelet-poor-plasma and platelet concentrate from a small sample of blood and for preparation of a cell concentrate from bone marrow, 
CODE Lot Numbers 337920 and 337930 and Lot Number 337890
RECALLING FIRM/MANUFACTURER Biomet, Inc., Warsaw ,  IN 
REASON A 30 ml tube is packaged with the kit instead of the labeled 60 ml tube.
VOLUME OF PRODUCT IN COMMERCE 27 kits
DISTRIBUTION Nationwide and countries of Germany and Italy

WEEK ENDING APRIL 18

PRODUCT Zoll AED Plus Defibrillator, 
CODE Serial numbers below X_ _ _200000
RECALLING FIRM/MANUFACTURER
ZOLL Medical Corp., World Wide Headquarters, Chelmsford , MA 
REASON Device fails to discharge the defibrillation energy.
VOLUME OF PRODUCT IN COMMERCE
183,535 units
DISTRIBUTION Nationwide and Internationally
 
PRODUCT
a) Viasys Healthcare , Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0469 Sonara Unilateral. The Sonara Transcranial Doppler system is a medical ultrasound device for noninvasively measuring the blood flow velocities in arteries and veins, 
 
b) Viasys Healthcare , Sonora Transcranial Doppler (TCD) System. Model Sonara. Part Number of Units: 982A0470 Sonara Bilateral. The Sonara Transcranial Doppler system is a medical ultrasound device for noninvasively measuring the blood flow velocities in arteries and veins,
CODE
a) Serial Numbers: PWH0297 PWH0212 PWH0221 PWH0309 PWH0246 PWH0250 PWH0223 PWH0429 PWH0245 PWH0292 PWH0298 PWH0214 PWH0211 PWH0210 PWH0219 PWH0216 PWH0224 PWH0215 PWH0213 PWH0220 PWH0253 PWH0252 PWH0254 PWH0221 PWH0218 PWH0217 06-2506 06-2504 05-2506 PWH0251 06-2501 06-2500 06-2503 06-2502 05-2502 and 05-2500;
 
b) Serial Numbers: PWH0267 PWH0316 PWH0269 PWH0284 PWH0201 PWH0269 PWH0264 PWH0259 PWH0226 PWH0280 PWH0278 PWH0277 05-2507 05-2505 05-2504 06-2512 PWH0262 PWH0209 PWH0274 PWH0263 PWH0239 PWH0203 PWH0244 PWH0341 PWH0257 PWH0240 PWH0315 PWH0225 PWH0234 PWH0340 PWH0232 PWH0205 PWH0204 PWH0282 PWH0230 PWH0208 PWH0265 PWH0207 PWH0200 PWH0270 PWH0202 PWH0281 PWH0279 PWH0227 PWH0255 PWH0273 PWH0206 06-2505 06-2509 05-2508 06-2508 PWH0238 PWH0237 PWH0276 PWH0229 PWH0236 PWH0228 PWH0241 06-2507 PWH0258 PWH0242 PWH0271 and PWH0233
RECALLING FIRM/MANUFACTURER
Cardinal Health, Inc., Madison , WI
REASON
Internal testing has identified several scenarios where unexpected System lockups, shutdowns or system errors would render the Sonara unavailable for use until the Sonara can be restarted. These issues can be corrected by installing the Version 6.0 b045 software updating the Audio Driver and updating to XP Service Pack 3. Additionally, improper wiring could cause the cooling fan to not operate properly. This could present itself as a lockup within approximately 20 minute of initial operation. Installation of the items will help prevent the occurrence of unexpected lockups which could result in the loss of the display information during monitoring and could lead to serious consequences during surgical monitoring.
VOLUME OF PRODUCT IN COMMERCE
100 systems
DISTRIBUTION
FL, DC, LA, NJ, NY, PA, TN, TX, WI, CA, MO, and LA and countries including Thailand, Singapore, Serbia-Montenegro, Portugal, Philippines, Poland, Norway, Netherlands, Korea, Italy, Israel, Hungary, Hong Kong, Great Britain, Spain, Germany, Czech Republic, Switzerland, Canada, Bulgaria, and Bosnia-Herzegovina

PRODUCT Biomet Offset Tibial Tray Adaptor, 5.0 MM, sterile, REF 141491. The Biomet Offset Tibial Tray Adaptor is a knee prosthesis intended for cemented use in patients with the following indications: painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved, correction of valgus, varus or posttraumatic deformity, correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure, 
CODE Lot number: 644290
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw , IN ,
REASON A 2.5mm locking insert was packaged with the 5.0mm Offset Tibial Tray Adaptor instead of the 5.0mm locking insert.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
Nationwide, countries of Germany , Italy , Netherlands , Spain and the United Kingdom

PRODUCT CELL-Dyn Ruby Hematology Analyzer, List Number 08H67-01 The CELL-DYN Ruby is a multi-parameter, automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: the Autoloader mode that aspirates samples from closed collection tubes and the Open Tube mode that aspirates samples from open collection tubes, CODE Serial No. 34001BG - 34965BG
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Santa Clara , CA 
REASON Carryover failures in software revisions 1.0ML and 2.0ML result in elevated PLT background count.
VOLUME OF PRODUCT IN COMMERCE
604 units
DISTRIBUTION
Nationwide, and countries of Argentina, Australia, Bermuda, Brazil, Canada, China, Chile, Columbia, Costa Rica, Ecuador, Dominican Republic, El Salvador, Guatemala, Germany, Guyana, Hong Kong, Jamaica, Japan, Mexico, Panama, Peru, Puerto Rico, Singapore, South Korea, Taiwan, Venezuela and the Virgin Islands

PRODUCT
a) Roche/Hitachi Modular Analytics System, clinical chemistry analyzer Modular D2400 Module; GMMI No. 04998618001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays
 
b) Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P800 Module; GMMI No. 04998669001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays, 
 
c) Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular D Module; GMMI No. 03284522001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays, 
 
d) Roche/Hitachi Modular Analytics System, clinical chemistry analyzer, Modular P Module; GMMI No. 03284549001. Is a fully automatic, computerized chemistry analyzer intended for in vitro quantitative and qualitative determinations of a wide range analytes. The instrument is capable of performing potentiometric and photometric assays, 
CODE
All units with software version 08-03
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis ,  IN 
Manufacturer: Division, Hitachi Ltd., Hitachinaka-Ibaraki , Japan . 
REASON If a masked module is unmasked during the reagent registration process, the calibration parameters may be assigned to the wrong reagents, resulting in the reporting of incorrect control and sample results.
VOLUME OF PRODUCT IN COMMERCE
22 modules
DISTRIBUTION Nationwide

PRODUCT
a) Convoy Advanced Delivery Sheath Kit, Model Numbers: M0045660ST0, M0045661ST0, M0045662ST0, M0045663ST0, M0045665ST0, M0045667ST0, M0045670ST0, M0045672ST0, M0045675ST0, M0045676ST0, M0045690ST0, M0045890ST0, M0045748ST0 and M0045749ST0. Product is intended for use to facilitate the intracardiac placement of interventional devices, 
 
b) Soft Tip Sheath Multipurpose Introducing Sheath Kit, Model Numbers: M00456600, M00456610, M00456620, M00456630, M00456650, M00456700, M00456710 and M00456760. Product is intended for use to facilitate the percutaneous introduction of various types of cardiovascular catheters into either the right or left side of the heart. The sheath may be exchanged and used for left sided placement, after transseptal puncture has first been obtained by another sheath, 
CODE
a) Batch Numbers: S1721 4 S1899 6 S2103 9 S2287 6 S2497 2 S1724 9 S1903 2 S2105 6 S2287 7 S2513 9 S1732 2 S1913 1 S2109 5 S2295 6 S2522 7 S1733 8 S1913 2 S2115 2 S2295 9 S2524 0 S1735 6 S1913 3 S2118 9 S2296 4 S2536 0 S1737 1 S1926 5 S2123 4 S2297 1 S2553 7 S1737 2 S1930 1 S2135 6 S2299 4 S2553 8 S1737 4 S1956 3 S2151 1 S2299 5 S2555 1 S1757 4 S1962 0 S2156 4 S2301 4 S2557 8 S1766 6 S1962 1 S2161 5 S2305 1 S2562 9 S1766 7 S1964 4 S2166 4 S2306 9 S2566 1 S1766 8 S1970 4 S2166 5 S2307 0 S2566 4 S1792 6 S2015 1 S2166 6 S2308 9 S2567 6 S1792 S2015 S2180 S2309 and S2579;
 
b) Batch Numbers: 5660, 5662, 5665, 5671, 5661, 5663, 5670 and 5676 and Batch Numbers: S17665, S2053, S1827, S2283,S2382,S20023, S2100, S1917, S2314,S2200, S21439, S2144, S1956, S2315, S2002, S22763, S2240, S2027, S2390, S2305, S2382, S2276,S2053, S2520,S23827, S17392, S2305, S2077, S2559, S1701, S18274, S2386, S2100, S2588, S1701, S19033, S2542, S2121,S2637, S2421, S19561, S1734, S2240, S1918, S20021, S1746, S2280, S2305, S1823 1 S2016 8 S2221 8 S2310 6 S2582 7 S1823 2 S2029 6 S2223 0 S2310 7 S2589 0 S1827 6 S2037 0 S2223 1 S2310 8 S2600 7 S1847 2 S2043 7 S2223 2 S2342 8 S2613 9 S1864 9 S2043 8 S2229 5 S2346 4 S2615 7 S1869 6 S2043 9 S2229 6 S2346 5 S2615 8 S1870 9 S2044 0 S2229 7 S2360 6 S2621 5 S1874 9 S2049 5 S2248 5 S2360 7 S2632 8 S1884 4 S2071 5 S2250 5 S2369 9 S2632 9 S1888 4 S2071 6 S2250 8 S2371 7 S2635 9 S1892 1 S2082 1 S2274 1 S2405 8 S2641 5 S1895 8 S2099 6 S2274 2 S2413 0 S2648 1 S1899 2 S2099 7 S2277 5 S2413 1 S1899 3 S2100 5 S2277 6 S2447 3 S1899 4 S2102 0 S2279 4 S2478 4 S1899 5 S2102 1 S2282 6 and S2493 3
RECALLING FIRM/MANUFACTURER
Boston Scientific, Corp., San Jose , CA ,
REASON The marker band may detach from the sheath and a clinical failure could result in an embolism.
VOLUME OF PRODUCT IN COMMERCE
31,340 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Healthcare Infinia Hawkeye(R), Model numbers: H2508PY H3000WN H3000WR H3000WW H3000WY H3000WZ H3000YM H3000YS Intended use: To perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, 
 
b) GE Healthcare Infinia Hawkeye(R) 4, Model numbers: H3000WC H3000WD Intended use: To perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, 
CODE
a) H2508PY: S/N 16076 16010 16177, and 16175. H3000WN: 16433 and 16366 H3000WR: 16275, 16306, and 16379. H3000WW: 16584 16690 16146 16328 16292 16530 16574 16619 16321 16545 16586 16193 16351 16393 16435 16439 16471 16217 16274 16459 16438 17022 16347 16302 16717 16689 16989 16998 17039 16480 16584 16593 16568 16458 16951 16711 16417 16906 17038 16458 16727 16003 16247 16386 16729 16402 16398 16529 16708 16277 16754 16294 16604 16591 16642 16383 16463 16268 16554 16690 16467 16357 16316 16879 16367 16745 16535 16675 16581 16399 16501 16507 16222 16461 16602 16769 16782 16956 16836 16445 16493 16384 16486 16693 16894 16343 16452 16801 16631 16633 16931 16631 16618 16200 16702 16818 16341 16556 16299 16345 16329 16753 16348 16257 16610 16258 16707 16369 16253 16958 16284 16703 16252 16638 16254 16278 16333 16231 16368 16709 16265 16488 16884 16330 16845 16558 16630 16490 16855 16563 16599 16431 16414 16714 16327 16360 16647 16577 16883 16625 16605 16201 16892 16603 16652 16623 16339 16671 16270 16407 16476 16416 16390 16451 16424 16952 16276 16236 16496 16895 16484 16654 16620 16230 16406 16985 16359 16273 16597 16482 16429 16338 16607 16388 16847 16573 16606 16824 16472 16981 16374 16835 16562 16288 16241 16609 16203 16508 16342 16363 16444 16260 16678 16342 16202 16598 16550 16615 16440 16362 16506 16272 16389 16936 16332 16508 16521 16687 16629 16588 16700 16358 16307 16432 16595 16997 16787 16590 16653 16580 16287 16514 16515 16555 16777 16192 16555 16199 16385 16764 16544 16232 16523 16256 16954 16982 16309 16242 16257 16644 16797 16267 16283 16280 16549 16596 16637 16691 16697 16757 16980 16681 16684 16679 16730 16546 16352 H3000WY: 16616 17083 16282 16897 16532 16143 16423 16204 17085 16423, and 16289. H3000WZ: 16350 16752 16375 16582 16237 16238 16183 16176 16403 16468 17148 16239 16349 16572 16996 16086 16240 16552 16485 16815 16813 16826 17079 16601 16495 16522 16240 16264 16248 16624 16961 16780 16409 16205 16387 16487 16481 16891 16449 16361 16215 16831 16462 16261 16512 16578 16197 16205 16565 16430 16397, and 16251. H3000YM: 16146 16057 16133 16100 16157 16172 16024 16174 16147 16125 16164 16120 16131 16127 16132 16040 16024 16128 16052 16055 16070 16013 16011 16029 16110 16028 16009 16060 16173 16008 16082 16027 16151 16153 16154 16064 16163 16007 16030 16037 16124 16046 16020 16112 16121 16103 16063 16169 16035 16042 16059 16109 16021 16159 16062 16073 16148 16149 16156 16053 16038 16019 16023 16078 16150, and 16101. H3000YS: 16061 16134 16095 16085 16152 16089 16074 16168 16141 16067 16068, and 16056;
 
b) H3000WC : S/N 17032 17391 16844 17215 16974 16979 17090 16898 16967 17136 17057 17130 17121 17337 17298 17376 17208 17114 16876 17164 17247 17276 17286 17293 17317 17070 17391 17220 16905 17011 16850 16947 17347 17082 16880 16910 17288 16933 17061 17198 16994 17265 16820 17106 17058 17047 17053 17116 16852 17169 17029 17195 17169 16938 17125 16970 16774 17226 16886 17118 16945 17348 16924 16888 16811 17122 17389 17020 17135 16962 17101 16849 17233 17137 17300 17299 17268 16960 17326 17050 17269 17131 17204 17349 17034 17005 17213 17301 17019 16987 17108 17088 17166 17287 17099 17023 16927 17328 17174 17042 16821 16914 16972 17285 17323 17104 17241 17258 17249 17109 16977 16946 16975 17162 17002 16862 16869 17219 16887 16950 16949 16874 17147 16965 16889 17290 17055 17185 16966 17046 17112 17041 17289 17178 17103 17139 17260 16986 17000 17105 17390 17331 17098 17297 17052 17089 17373 17264 16871 17199 17190 17124 17382 16925 17159 17062 17372 16944 17173 17388 16885 17254 17187 17278 16934 16901 17231 17295 16932 16893 17025 17100 16878 16955 17360 16921 16922 16838 16876 16865 16926 16856 16928 16930 17333 17018 17363 17277 16968 17024 17210 17172 17251 17197 16911 16978 17049 16919 17338 17179 17259 17248 17351 17238 17165 17048 17206, and 17158. H3000WD: 17154 17310 17113 17072 17163 17236 17067 17107 17346 17252 17126, and 17379
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesha , WI , 
Manufacturer: GE Medical System, Tirat Hacarmel , Israel . 
REASON There is a possibility for misregistration when brain scans are performed with Infinia with the Hawkeye option. This misregistration could present the potential for misdiagnosis when the patient headrest sags under the weight of a head.
VOLUME OF PRODUCT IN COMMERCE
639 units
DISTRIBUTION
Nationwide, and countries of Australia, Belgium, Brazil, Canada, China, Columbia, Czech Republic, Denmark, Ecuador, Finland, France, Georgia, Germany, India, Indonesia, Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Poland, Puerto Rico, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom

PRODUCT
a) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00200W, 16F x 1.2cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 
 
b) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00201W, 16F x 1.7cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device,
 
c) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00202W, 16F x 2.4cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 
 
d) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00203W, 20F x 1.2cm, 10cc. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 
 
e) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00204W, 20F x 1.7cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 
 
f) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00205W, 20F x 2.4cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 
 
g) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00206W, 20F x 3.4cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 
 
h) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00207W, 20F x 4.4cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 

i) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00210, 16F x 2.4cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 
 
j) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00212W, 20F x 1.7cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 
 
k) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00213W, 20F x 2.4cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 
 
l) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00214W, 20F x 3.4cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 
 
m) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00215W, 20F x 4.4cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 
 
n) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00216W, 24F x 1.7cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 
 
o ) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00217W, 24F x 2.4cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 
 
p) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00218W, 24F x 3.4cm, 20cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 
 
q ) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00219W, 24F x 4.4cm, 20cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 
 
r) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00221W, 18F x 1.2cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 
 
s) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00222W, 18F x 1.7cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 
 
t) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00223W, 18F x 2.4cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 
 
u) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00224W, 18F x 3.4cm, 10cc, Sterile EO. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 
 
v) Dual Port Wizard Low Profile Replacement Gastrostomy Device, REF 00225W, 18F x 4.4cm, 10cc, Sterile EO, Bard Access Systems, Inc., Salt Lake City, UT 84116. A silicone low-profile balloon-type device is designed for percutaneous insertion through an established, appropriately sized stoma tract. It is a component of the Dual Port Wizard Gastrostomy Device, 
CODE
a) Lot numbers: HUSC0041, HUSC0042, HUSD0281, HUSD0326, HUSD1983, HUSD1984, HUSE1554, HUSF1907, HUSF1908, HUSG1086, HUSG1087, HUSH1621, HUSH1651, HUSI2748 and HUSI2749;
 
b) Lot numbers: HUSA0398, HUSA1482, HUSA1483, HUSC0043, HUSC0044, HUSD0282, HUSD0327, HUSD1985, HUSD1986, HUSE1555, HUSF1909, HUSG0010, HUSG1088, HUSH1632, HUSH1652 and HUSI2750;
 
c) Lot numbers: HUSC0045, HUSC2106, HUSD0283, HUSD1987, HUSD1988, HUSE1556, HUSF1910, HUSF1911, HUSG0498, HUSG1089, HUSG1090, HUSH1622, HUSH1653, HUSI2701 and HUSI2751;
 
d) Lot numbers: HUSB0169, HUSC0046, HUSD0328, HUSD1989, HUSD1990, HUSE1557, HUSG1091, HUSG1092, HUSH1633 and HUSI2752;
 
e) Lot numbers: HUSA0401, HUSC0047, HUSC0048, HUSD0284, HUSD0329, HUSD1991, HUSD1992, HUSE0948, HUSE1558, HUSF1912, HUSG1096, HUSG1098, HUSH1634, HUSH1654, HUSI2702 and HUSI2753;
 
f) Lot numbers: HUSB1653, HUSB1654, HUSC0049, HUSD0330, HUSD0331, HUSD1614, HUSD1913, HUSD1993, HUSE1559, HUSE1560, HUSF1282, HUSF1913, HUSF1914, HUSG1099, HUSG1100, HUSG1101, HUSH1623, HUSH1624, HUSH1655, HUSI2754, HUSI2755 and HUSI2756;
 
g) Lot numbers: HUSB1655, HUSB1656, HUSC0050, HUSC0051, HUSC0052, HUSD0285, HUSD0332, HUSD0333, HUSD1191, HUSD1615, HUSD1994, HUSD1996, HUSE1561, HUSE1562, HUSF1283, HUSG1102, HUSG1103, HUSG1104, HUSH0472, HUSH1625, HUSH1626, HUSH1656, HUSI2757, HUSI2758, HUSI2759 and HUSI2760;
 
h) Lot numbers: HUSA0411, HUSA0412, HUSC0040, HUSD0334, HUSD0335, HUSD1910, HUSD1997, HUSE1563, HUSF1284, HUSF1915, HUSG1105, HUSH1604 and HUSI2761;
 
i) Lot numbers: HUSA0415 and HUSI2762;
 
j) Lot numbers: HUSA0416, HUSD0336 and HUSI2763;
 
k) Lot numbers: HUSA0421, HUSD0337, HUSD1998, HUSF1916, HUSG1107, HUSH1657 and HUSI2764;
 
l) Lot numbers: HUSA0422, HUSD0338, HUSD1999, HUSF1917, HUSG1108, HUSH1658 and HUSI2765;
 
m) Lot numbers: HUSA0435, HUSD0286, HUSD2000, HUSH1659 and HUSI2766;
 
n) Lot numbers: HUSB0170, HUSC0071, HUSC0072, HUSC2107, HUSD2001, HUSD2002, HUSE1564, HUSF1918, HUSG1109, HUSH1605, HUSH1660 and HUSI2767;
 
o) Lot numbers: HUSA0438, HUSB0171, HUSC0073, HUSD0339, HUSD0340, HUSD1911, HUSD2003, HUSE1565, HUSE1566, HUSF1285, HUSF1919, HUSG1110, HUSG1111, HUSH1635, HUSH1661, HUSI2703, and HUSI 2707;
 
p) Lot numbers: HUSB1657, HUSB1658, HUSC0106, HUSC0107, HUSD0341, HUSD1912, HUSD2004, HUSD2183, HUSE1567, HUSF1286, HUSG1112, HUSH1636, HUSH1662 and HUSI2708;
 
q) Lot numbers: HUSB0172, HUSC0114, HUSD0342, HUSD0343, HUSD2005, HUSE1568, HUSF1921, HUSG1113, HUSH1606, HUSH1665, and HUSI2710;
 
r) Lot numbers: HUSA0453, HUSD2008, HUSF1922, HUSG0671 and HUSI2768;
 
s) Lot numbers: HUSA0454, HUSA0455, HUSA1490, HUSC0128, HUSD0345, HUSD0346, HUSD2009, HUSD2010, HUSE1570, HUSE1571, HUSF1923, HUSF1924, HUSG1116, HUSG1117, HUSH1297, HUSH1627, HUSH1666, HUSI2769 and HUSI2770;
 
t) Lot numbers: HUSB0174, HUSC0130, HUSC2109, HUSD0347, HUSD0569, HUSD2011, HUSD2012, HUSE0954, HUSE1572, HUSE1573, HUSF1927, HUSF1928, HUSG1118, HUSG1119, HUSH1628, HUSH1667, HUSI2771 and HUSI2772;
 
u) Lot numbers: HUSA0458, HUSA0459, HUSC0131, HUSC1295, HUSD0348, HUSD0349, HUSD2013, HUSD2014, HUSE0894, HUSE1574, HUSF1925, HUSF1926, HUSG1120, HUSH1629, HUSH1668, HUSI2711 and HUSI2773;
 
v) Lot numbers: HUSA0460, HUSB0188, HUSC0132, HUSD0350, HUSD2015, HUSD2016, HUSE1575, HUSF1929, HUSG1121, HUSH1637, HUSH1669 and HUSI2712
RECALLING FIRM/MANUFACTURER
Recalling Firm: C R Bard, Inc., Salt Lake City , UT 
Manufacturer: Bard Puerto Rico , Las Piedras, PR. 
REASON Out of specification replacement gastrostomy device was distributed.
VOLUME OF PRODUCT IN COMMERCE
29,939 units
DISTRIBUTION
NV, PA, WV, CA and NC, and countries of Canada, Japan, Finland, Norway, Sweden, Austria, Belgium, Holland, United Kingdom, Italy, France, Switzerland, Spain and Germany, Australia, and Latin America

PRODUCT
a) GE Healthcare, Infinia, Model Numbers: ASM000886 ASM001391 ASM001333 ASM001465 ASM001473 ASM001620 ASM500016 H3000WM H3000WT H3000WY and SYS000041. The device is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, 
 
b) GE Healthcare, Hawkeye for Infinia, Model Numbers: H3000WR, H3000WW, H3000WZ, H3000YM and H3000YS. The device is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, 
 
c) GE Healthcare, Infinia Hawkeye 4, Model Numbers: 5178728, ASM500060, H3000WC and H3000WD. The device is used to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications, 
CODE
a) Model Number ASM000886: 16017 16004 16007 16012 16006 16008 16010 16023 16039 16026 16025 16015 16052 16022 16055 16065 16027 16142 16084 16101 16030 16054 16079 16042 16064 16062 16109 16060 16100 16097 16129 16125 16130 16160 16110 16136 16151 16161 16145 16184 16173 16156 16080 16178 16126 16113 16096 16107 16170 16003 16059 17049 17029 17061 17050 17052 17046 17029 17068 and 17154; Model Number ASM001333: 16001 16049 16043 16040 16028 16009 16051 16053 16044 16037 16015 16099 16035 16048 16020 16053 16013 16026 16036 and 16014; Model Number ASM001391: 16063 16076 16073 16102 16106 16088 16075 16122 16124 16074 16120 16083 16149 16152 16056 16150 16153 16105 16162 16182 16163 16166 16188 16132 16058 16167 16131 16216 16168 16217 16221 16179 16164 16094 16169 16187 16090 16172 16177 16175 16093 16183 16186 16091 16246 16238 16041 16174 16104 16050 16073 16140 16078 16139 16158 and 16067; Model Number ASM001465: 16195 16192 16205 16198 16212 16219 16210 16206 16193 16227 16270 16273 16203 16267 16281 16288 16200 16313 16342 16294 16330 16286 16303 16327 16299 16332 16243 16252 16333 16290 16364 16360 16339 16335 16344 16245 16381 16385 16176 16377 16362 16366 16388 16320 16334 16399 16384 16380 16412 16413 16411 16236 16369 16432 16428 16289 16404 16405 16408 16256 16414 16429 16365 16427 16433 16394 16343 16230 16441 16426 16443 16435 16439 16470 16471 16391 16223 16466 16475 16376 16464 16455 16511 16349 16510 16514 16515 16500 16532 16451 16538 16493 16533 16537 16547 16487 16395 16482 16505 16528 16517 16549 16560 16529 16508 16520 16564 16445 16438 16476 16278 16378 16347 16211 16415 and 16421; Model Number ASM001473: 16254 16276 16316 16314 16308 16283 16323 16298 16326 16284 16280 16262 16345 16331 16291 16337 16312 16352 16371 16346 16355 16368 16315 16356 16266 16379 16410 16398 16321 16416 16293 16340 16374 16429 16318 16406 16420 16319 16456 16440 16450 16449 16477 16460 16329 16302 16492 16474 16448 16499 16498 16490 16478 16430 16494 16496 16309 16400 16491 16452 16419 16328 16397 16462 16191 16418 and 16495; Model Number ASM001620: 16581 16574 16592 16645 16632 16622 16611 16661 16668 16595 16625 16587 16656 16708 16629 16638 16566 16663 16617 16694 16721 16692 16673 16742 16702 16738 16675 16745 16725 16715 16719 16688 16613 16726 16704 16714 16777 16674 16776 16805 16645 16770 16782 16759 16791 16837 16798 16836 16830 16842 16766 16853 16616 16577 16847 16835 16857 16851 16860 16824 16858 16834 16653 16818 16894 16752 16736 16883 16655 16870 16875 16896 16594 16902 16801 16868 16881 16909 16943 16897 16941 16939 16942 16819 16867 16810 16877 16940 16890 16839 16980 16668 16989 16740 16717 16956 16997 17083 16923 17022 16996 16705 17039 and 16695; Model Number ASM500016: 16501 16522 16534 16535 16576 16575 16553 16516 16506 16562 16557 16542 16541 16551 16602 16573 16614 16583 16586 16571 16607 16569 16578 16621 16649 16635 16669 16593 16639 16647 16681 16660 16580 16684 16679 16677 16686 16646 16657 16667 16637 16693 16699 16689 16665 16654 16676 16666 16697 16718 16610 16701 16563 16716 16579 16424 16710 16698 16707 16733 16747 16584 16706 16709 16765 16239 16605 16725 16741 16768 16749 16751 16779 16746 16750 16792 16773 16536 16780 16790 16769 16600 16797 16814 16817 16807 16802 16601 16690 17030 and 16815; Model Number H3000WM: 16353; Model Number H3000WT: 16115 16207 16224 16229 16220 16208 16235 16244 16234 16250 16279 16295 16269 16301 16285 16293 16324 16255 16271 16370 16233 16372 16422 16442 16382 16437 16453 16425 16457 16454 16465 16259 16469 16509 16519 16497 16527 16479 16531 16524 16434 16489 16567 16539 16502 16446 16311 16627 16640 16608 16636 16641 16634 16540 16659 16628 16643 16658 16209 16228 16685 16626 16513 16548 16664 16672 16559 16670 16662 16720 16696 16734 16713 16763 16735 16748 16761 16767 16775 16803 16762 16536 16783 16812 16310 16392 16731 16788 16728 16723 16214 16504 16799 16502 16249 16503 16756 16760 16680 16376 16518 16612 16525 16300 16297 16447 16732 16786 16710 16758 16786 16731 16213 16808 16804 16135 16848 16800 16833 16816 16806 16789 16822 16841 16840 16839 16829 16832 16437 16587 16866 16861 16863 16825 16900 16916 16872 16882 16908 16917 16772 16929 16935 16920 16778 16959 16964 16196 16263 16305 16913 16526 16648 16796 16991 16912 17003 17031 17006 17056 17012 16971 16983 16851 17009 17027 17073 17014 17074 17064 17043 17117 17080 17155 17059 17142 17160 17152 17123 16296 16904 17146 17212 17177 17216 17218 17015 17223 16993 16218 17184 17234 17246 17275 17282 17274 17257 17279 17291 17134 17270 17196 17308 17302 17230 16984 17261 17334 17355 17315 17242 17168 17283 16973 17378 17371 17380 17393 17409 17396 17292 17221 17186 and 16483; Model Number H3000WY: 16282 16204 16423 16143 16423 and 17085; and Model Number SYS000041: 16005 16034 16018 16045 16092 16016 16123 16098 16072 16084 16111 16136 16108 16155 16116 16180 16189 16185 and 16137;
 
b) Model Number H3000WR: 16306 and 16275; Model Number H3000WW: 16086 16202 16231 16241 16268 16265 16247 16277 16201 16272 16274 16258 16278 16242 16257 16341 16307 16232 16351 16358 16363 16383 16134 16383 16367 16095 16359 16338 16390 16407 16253 16463 16242 16461 16484 16467 16472 16486 16393 16488 16507 16545 16459 16546 16523 16550 16521 16402 16417 16599 16556 16480 16558 16597 16555 16590 16603 16598 16606 16618 16630 16596 16530 16619 16609 16631 16623 16691 16708 16620 16633 16642 16599 16703 16591 16671 16764 16757 16604 16787 16615 16287 16690 16568 16458 16711 16727 16386 16729 16444 16260 16678 16687 16588 16700 16653 16730 16782 16824 16342 16879 16003 16801 16884 16292 16906 16892 16931 16952 16954 16222 16936 16895 16257 16951 16373 16958 16389 16982 16981 17038 16754 16985 16998 16855 16458 16644 and 16544; Model Number H3000WZ: 16237 16350 16251 16375 16387 16512 16565 16582 16403 16240 16183 16572 16485 16552 16248 16215 16261 16197 16468 16361 16624 16813 16409 16831 16481 16240 16264 16891 16961 16826 and 17148; Model Number H3000YM: 16046 16011 16021 16057 16027 16128 16077 16097 16019 16103 16082 16112 16029 16121 16157 16148 16159 16038 16147 16146 16127 16154 16174 16024 and 16133; and Model Number H3000YS: 16068 16089 16141 16085 and 16061;
 
c) Model Number 5178728: 17445 17001 17035 17023 17008 16988 17007 17010 17063 17077 17053 16995 17088 17098 17090 16990 17054 17099 17081 17060 17128 17140 17116 17004 17089 17036 17045 17129 17130 17108 17093 17171 17144 17158 17069 17135 17040 17172 17132 17183 17153 17201 17182 17111 17190 17187 17175 17169 17133 17213 17166 17104 17203 17141 17204 17139 17113 17224 17226 17228 17210 17229 17119 17255 17239 17233 17002 17266 17245 17276 17264 17248 17094 17256 17273 17254 17281 17294 17305 17277 17250 17252 17287 17307 17325 17285 17317 17288 17272 17299 17220 17321 17329 17341 17314 17293 17335 17328 17286 17366 17350 17306 17342 17096 17365 17309 17364 17349 17339 17369 17300 17390 17387 17361 17394 17376 17403 17359 17437 17415 17389 17382 17435 17423 17304 17449 17297 and 17241; Model Number ASM500060: 16821 16820 16846 16865 16852 16862 16880 16774 16893 16888 16874 16924 16928 16927 16933 16926 16937 16934 16938 16844 16930 16969 16962 16963 16977 16925 16901 16945 17005 16986 16914 17020 16944 16885 17034 17019 16949 17057 17055 17058 16976 16965 16976 17047 16987 and 17070; Model Number H3000WC: 16838 16849 16856 16850 16876 16869 16878 16811 16871 16889 16905 16898 16911 16921 16922 16910 16932 16886 16974 16955 16887 16919 16978 16968 16947 16979 16967 16972 16966 16970 17011 16994 17024 16950 17048 17042 17062 17018 17082 17105 17106 17000 17100 17125 17121 17025 17136 17122 17118 17041 17131 17103 17174 17164 17109 17197 17101 17114 16960 17199 17198 17124 17195 17179 17112 17185 17219 17238 17178 17247 17173 17265 16975 17259 17298 17260 17301 17278 17231 17165 17289 17290 17295 17333 17251 17338 17337 16946 17348 17373 17363 17347 17323 17326 17430 17416 17429 17415 17208 17422 17450 17258 and 17249; and Model Number HH3000WD: 17072 17126 17067 17107 17163 17236 17346 and 17379
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesha , WI , 
Manufacturer: GE Medical System, Tirat Hacarmel , Israel . 
REASON The metal pin in the adjustable head holder, which is used to acquire Brain SPECT data on Infinia systems (Infinia, Infinia Hawkeye, and Infinia Hawkeye 4), creates an artifact on the patient's cerebellum, which may lead to the potential for misdiagnosis.
VOLUME OF PRODUCT IN COMMERCE
1,256 devices
DISTRIBUTION
Nationwide and countries of Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech, Denmark, Ecuador, Egypt, Finland, Finland, Egypt, Finland, France, Germany, Greece, Hungry, India, Indonesia, Ireland, Israel, Italy, Japan, Korea, Malaysia, Martinique, Mexico, Netherlands, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Republic of Georgia, Russia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, and United Kingdom

PRODUCT ReadyMed Elastomeric Ambulatory Pump, Model Numbers: R050050, R100100, R100200, R250050, R250100, and R250167. Intended for self-administration of anti-microbial and antiviral agents, 
CODE
Lot Numbers: 8105650 8105554 8105467 8105466 8105421 8105176 8105424 8105322 8105092 8105175 8105094 8105174 8105002 8105084 8105001 8105003 8096111 8096036 8095983 8095872 8095373 8095854 8095733 8095748 8095683 8095512 8095424 8095372 8095295 8095299 8095217 8095116 8095114 8095003 8095002 8095001 8095006 8085820 8085729 8085623 8085566 8085567 8085520 8085454 8085394 8085314 8085279 8085199 8085184 8085003 8085006 8085005 8085004 8085002 8085001 8075963 8075932 8075924 8075846 8075769 8075679 8075782 8075675 8075590 8075588 8075522 8075471 8075465 8075414 8075374 8075413 8075280 8075277 8075182 8075177 8075123 8075119 8075118 8075004 8075014 8075003 8075002 8075001 8065668 8065683 8065667 8065507 8065504 8065408 8065224 8065409 8065376 8065223 8065332 8065178 8065176 8065108 8065107 8065003 8065002 8065001 8055718 8055665 8055664 8055662 8055627 8055598 8055567 8055522 8055478 8055474 8055312 8055404 8055413 8055282 8055281 8055241 8055166 8055221 8055165 8055126 8055072 8055063 8055044 8055002 8055001 8055003 8046137 8046064 8046002 8045985 8045930 8045883 8045923 8045812 8045864 8045798 8045738 8045767 8045719 8045569 8045638 8045565 8045518 8045478 8045367 8045180 8045440 8045360 8045336 8045222 8045114 8045017 8035669 8045002 8045067 8045001 8035639 8035363 8035362 8035196 8035320 8035173 8035319 8035250 8035459 8035194 8035249 8035122 8035018 8035002 8035003 8035001 8025647 8025502 8025688 8025585 8025209 8025130 8025406 8025503 8025290 8025324 8025208 8025174 8025079 8025156 8025003 8025004 8015789 8025002 8025001 8015863 8015921 8015741 8015784 8015684 8015685 8015637 8015638 8015564 8015547 8015548 8015498 8015326 8015227 8015478 8015281 8015226 8015108 8015003 8015058 8015002 8015057 8015001 7125677 7125744 7125732 7125652 7125602 7125563 7125527 7125516 7125437 7125439 7125284 7125355 7125304 7125205 7125165 7125158 7125126 7125108 7115565 7125003 7125002 7115858 7125001 7115796 7115767 7115634 7115631 7115683 7115476 7115583 7115369 7115439 7115420 7115283 7115368 7115229 7115134 7115225 7115078 7115074 7115001 7115004 7115003 7105847 7105743 7105839 7105789 7105778 7105741 7105742 7105634 7105600 7105211 7105456 7105448 7105447 7105248 7105312 7105157 7105004 7105078 7105003 7105001 7105002 7095846 7095355 7095844 7095736 7095737 7095559 7095584 7095439 7095237 7095440 7095175 7095135 7095093 7095004 7095003 7095002 7095001 7088687 7088517 7088516 7088515 7088550 7088309 7088381 7088308 7088305 7088199 7088198 7088184 7088185 7088112 7088110 7088111 7085260 7085259 7085166 7085222 7085051 7085003 7085167 7085123 7085002 7085145 7085005 7085001 7076045 7075841 7075709 7075792 7075708 7075580 7075678 7075476 7075352 7075448 7075447 7075159 7075405 7075068 7075160 7075066 7075005 7075002 7075001 7075004 7075003 7065851 7065897 7065850 7065763 7065762 7065647 7065736 7065544 7065601 7065602 7065510 7065418 7065179 7065366 7065004 7065309 7065127 7065231 7065036 7065003 7065002 7065001 7055764 7055654 7055714 7055653 7055631 7055548 7055537 7055536 7055521 7055296 7055378 7055224 7055222 7055175 7055001 7055174 7055078 7055061 7055003 7055002 7045756 7045755 7045681 7045577 7045682 7045515 7045512 7045466 7045269 7045467 7045397 7045347 7045313 7045060 7045224 7045177 7045172 7045119 7045118 7045061 7045055 7045002 7045001 7045003 7035919 7035815 7035799 7035818 7035798 7035656 7035769 7035490 7035489 7035600 7035451 7035448 7035243 7035297 7035181 7035125 7035124 7035003 7035002 7035001 7025703 7025604 7025614 7025604 7025528 7025459 7025423 7025370 7025315 7025284 7025188 7025091 7025069 7025054 7025038 7025037 7015881 7015841 7015737 7015736 7015626 7015619 7015475 7015091 7015406 7015474 7015409 7015408 7015330 7015407 7015329 7015279 7015280 7015236 7015235 7015194 7015193 7015090 7015045 7015041 7015040 7015001 6125411 6125326 6125553 6125552 6125124 6125119 6125118 6125433 6125410 6125123 6125262 6125261 6125325 6125001 6125122 6125002 6125117 6125050 6125003 6115978 6115829 6115769 6115768 6115540 6115539 6115394 6115521 6115392 6115393 6115325 6115364 6115324 6115180 6115071 6115178 6115069 6115010 6115066 6115008 6115007 6115009 6105796 6105732 6105795 6105794 6105689 6105731 6105688 6105661 6105660 6105594 6105593 6105554 6105553 6105173 6105474 6105465 6105464 6105304 6105305 6105172 6105303 6105117 6105108 6105040 6105039 6095621
RECALLING FIRM/MANUFACTURER
Cardinal Health 303 dba Cardinal Health, San Diego , CA 
REASON The recall was initiated as a result of a potential for out of specification flow rates. The product may not consistently meet the labeled flow rate range of +/- 15%.
VOLUME OF PRODUCT IN COMMERCE
Approximately 2.6 million units
DISTRIBUTION Nationwide

PRODUCT Internal Sterilizable Paddles and Handles without discharge control for use with LIFEPAK 9 and LIFEPAK 9P defibrillators/monitors. Internal Defibrillation Handles without discharge control: Part Numbers 800441-03 thru 800441-06 Internal Defibrillation Electrodes (threaded end): Part Numbers: 802154-10 thru 802154-19, 
CODE Sterilization labeling affects ALL part numbers referenced above.
RECALLING FIRM/MANUFACTURER
Physio Control, Inc., Redmond , WA 
REASON Sterilization efficacy can not be confirmed for the current methods of sterilization listed in the product labeling.
VOLUME OF PRODUCT IN COMMERCE
3,218 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Integra Bilayer Matrix Wound Dressing, 8 “ x 10” (20 cm x 25 cm); Non-pyrogenic, Do not Re-sterilize, Store flat at room temperature, Avoid Excessive heat, Avoid freezing. Sterile. Catalog number BMW810, 
CODE Lot number: 105BA0105205
RECALLING FIRM/MANUFACTURER
Integra LifeSciences, Corp., Plainsboro , NJ 
REASON Integra became aware of the potential of open seals in the foil pouch of the wound dressings.
VOLUME OF PRODUCT IN COMMERCE
125 units
DISTRIBUTION Nationwide

PRODUCT
a) Pilling(R) Coronary Scissors, 25Deg 7", Catalog numbers: 352164, 
 
b) Pilling(R) Coronary Scissors, 45Deg 7", Catalog numbers: 352165, 
 
c) Pilling(R) Coronary Scissors, 60Deg 7", Catalog numbers: 352166, 
 
d) Pilling(R) Coronary Scissors, 90Deg 7", Catalog numbers: 352167,
 
e) Pilling(R) Coronary Scissors, 120Deg 7", Catalog numbers: 352168, 
 
f) Beall(R) Circumflex Artery Scissors, Catalog numbers: 352169, 
 
g) Pilling(R) Coronary Scissors, 120Deg w/bar, Catalog numbers: and 352178, 
CODE
a) through g) Date Codes: RR8, SS8, TT8, UU8, VV8, WW8, XX8, and MM9
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Durham , NC 
Manufacturer: Teleflex Medical, Research Triangle Park , NC . 
REASON The product has a rough square finish instead of a smooth rounded finish which can cause damage to arteries.
VOLUME OF PRODUCT IN COMMERCE
497 units
DISTRIBUTION Nationwide and countries of Australia , Canada , France , Germany , India , Japan  and Singapore

PRODUCT diaDexus Inc. PLAC Test Reagent Kit, Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum, liquid ready-to-use two-reagent kit assembled in a kit box, Catalog number 90110 Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in Human Plasma or Serum on automated clinical chemistry analyzers, to be used in conjunction with clinical evaluations and patient risk assessment as an aide in predicting risk for coronary heart disease, and ischemic stroke associated with atherosclerosis, CODE Sublot of lot 088061, expiration date 2008-12
RECALLING FIRM/MANUFACTURER
DiaDexus, Inc., South San Francisco , CA
REASON Storage equipment failure at distributor site due to Hurricane Ike caused product to experience a temperature variation and go out of range. The integrity of the product could not be assured.
VOLUME OF PRODUCT IN COMMERCE
27 kits
DISTRIBUTION Nationwide
 
PRODUCT ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060. The device is used in the screening and titration of circulating antinuclear antibodies by means of an immunofluoresence test. Products are to be used as an aid in the detection of antibodies associated with systemic rheumatic disease, 
CODE
Sub Assembly Lot Numbers: 0823200, 0823201, and 0825500 and Kit Lot Numbers: 826305, 0827311, 0828107, 0828108, 0828109, 0830914, 0831607, 0831606, 0829719, 0827315, 0827301, 0829413, 0829512, 0826905, 0828114, 0828804, 0829414, 0829721, 0830300, 0828307 and 0829513
RECALLING FIRM/MANUFACTURER
Immuno Concepts, Inc., Sacramento , CA
REASON Samples can occasionally run out of the wells and cross contaminate adjacent wells.
VOLUME OF PRODUCT IN COMMERCE
378 kits
DISTRIBUTION NC, WI, MS, MD, IL, GA, CA, MI, PR, and Sweden , Mexico , Spain , and Denmark

PRODUCT Medtronic RV Lead Integrity Alert, Cat. # SW012, 1.0 software in EnTrust(R) (D153ATG, D153VRC, D154ATG, D154VRC) and EnTrust(R) Escudo (D144DRG, D144VRC) defibrillators, 
CODE v1.0 software
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Inc. Cardiac Rhythm Management, Mounds View, MN,
Manufacturer: Medtronic, Inc., Minneapolis ,  MN . REASON Medtronic has identified an issue related to installation or removal of the Lead Integrity Alert software in EnTrust(R) and EnTrust(R) Escudo" defibrillators. In those devices only, installation or removal of LIA will inadvertently turn off two audible patient alerts.
VOLUME OF PRODUCT IN COMMERCE
55,755 units
DISTRIBUTION
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, DC, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MI, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and countries of Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jamaica, Jordan, Kuwait, Lebanon, Macedonia, Martinique, Netherlands, Netherlands Antilles, Norway, Oman, Peru, Poland, Portugal, Puerto Rico, Qatar, Reunion, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom Vatican City State, Venezuela, and Virgin Islands

Arrow International Announces Recall of Intra Aortic Balloon Pump (IAB) Catheters

Teleflex Medical is recalling Arrow International’s Cardiac Care Division volume connectors for its 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters.

This recall is being conducted because a fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 cc or 5 cc, rather than the appropriate 30, 40, or 50 cc volume. In patients exhibiting moderate to severe myocardial ischemia or low perfusion states, prolonged exposure to the low default volume may fail to decrease ischemia and increase perfusion, leading to organ injury or infarct and may result in patient death. Prolonged exposure to a device which is inflated to less than 2/3 full could also result in thrombus formation on the IAB and possible subsequent systemic or cerebral thromboembolism.

Instructions contained in the operator’s manual fully describe the necessary warnings and precautions that will identify the issue. The recall notice restates these instructions and references the sections in the owner’s manual. If these instructions are followed, the issue for which the product was recalled can be discovered immediately, and the product can be removed and replaced.

PRODUCTS AFFECTED: 30/40/50 CC IAB Catheters:

PRODUCT CODES: IAB-04830-U, IAB-04840-U, IAB-05830-LWS, IAB05830-U, IAB-05840-U, IAB-05840-LWS, IAB06830-U, IAB06840-U, IAB-S730C, IAB-S840C, IAB-R950-U, IAK-02692, IAK-02693, and IAK-02691.

A list of products and lot numbers affected by this recall as well as the original recall notice can be found at Arrow’s website:

http://www.arrowintl.com/iab_recall.asp

Consumers with questions may contact the company at 1-800-523-8446; 8am to 8pm, ET, Monday through Friday, for international calls 001-919-361-4062; 8am to 5pm, ET, Monday through Friday.

WEEK ENDING APRIL 11

PRODUCT Spacers of varying lengths used with the InSTANT Stranding System, Part numbers: TG3138, TG3139, TG3140, TG3141 and TG3142. The spacer product is intended for consumption during the brachytherapy procedure. Unused (unopened) product is not intended to be inventoried by the attending physician, 
CODE Lot Numbers: 081009-01, 081009-02, 081009-03, 081023-01, 081023-02, 081106-01, 081106-02, 081106-03, 081113-01, 081113-02, 081113-03, 081113-04, 081113-05, 081118-01 and 081118-02
RECALLING FIRM/MANUFACTURER Theragenics Corp., Buford GA , 
REASON Some pouches were found to have weak seals potentially compromising sterility.
VOLUME OF PRODUCT IN COMMERCE 62 units
DISTRIBUTION Nationwide

PRODUCT GE Healthcare, S/5 iCentral and iCentral Client, Related to software licenses L-NET05 and L-NETC05. The iCentral maintains the network connections between the Datex-Ohmeda bedside monitors and other network devices in Monitor Network. Network connection consists of hardwire network and/or wireless LAN (WLAN) connection. The iCentral can be used for remote monitor management, storage, printing, viewing, reviewing or otherwise processing of information from several bedside monitors or other network devices. The Dates-Ohmeda Network will be used for patients in the hospital and it is meant for continuous use. The device is to be used by qualified personnel only, 
CODE
Serial Numbers: CZC6261MWB CZC6261MWY CZC5492LK6 CZC61030GL CZC64511LX CZC6482WKP CZC721500G CZC721500H CZC721500J CZC7290DYK CZC7290DYL CZC7290DYT CZC7290DYY 6203582 CZC5521M47 CZC5521M50 CZC7080QKD CZC73312RF CZC73312RP CZC6261MWF CZC7363P37 CZC72414B7 CZC72414BI CZC7250WN8 CZC6103069 CZC6130L3D CZC724149X CZC7272RM7 5225446 6022568 6043180 6065613 6131586 6131596 6203667 6228511 6279463 6307436 CZC5280BRX CZC528244P CZC528244X CZC53003BL CZC5391VF0 CZC5391VG3 CZC5391VGR CZC5472F7W CZC5492LKH CZC5492LKK CZC5510Y67 CZC603076F CZC603076M CZC603076T CZC603076Y CZC61544VJ CZC6181MTL CZC6322Q7G CZC6322Q7W CZC6322Q80 CZC6322Q8C CZC6394DFQ CZC6394DH3 CZC6394DH4 CZC6482WKK CZC6482WKS CZC7414GM8 FRB4210XPW FRB4210XPZ FRB4210XQD FRB4210XQF FRB4210XQG FRB4210XQV FRB4210XQY FRB4210XRD FRB4210XRP FRB4210XSS FRB4210XSX FRB4250QG9 FRB4250QGG FRB4250QGL FRB4250SM7 FRB4250SZR FRB4250T0N FRB4250T0V FRB426012N FRB426013F FRB426014Q 5205328 5170741 5126787 5170740 5170743 6030463 CZC5391VFK CZC5521M48 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5115313 5115312 5123576 5123577 5171816 5171817 5171818 5175460 5213706 5213745 6186143 CZC61030GV CZC6130L2W CZC6181MTK CZC6322Q8D CZC6482WLH CZC6482WLK CZC7105QFC CZC7132V7M CZC724149S CZC724149Z CZC7414GGP CZC5510Y66 5077176 5077177 5182720 CZC5472F7X CZC5472F7Y CZC5472F83 CZC5472F86 CZC5472F8C CZC5472F8H 5100657 5089748 5100629 5225450 5089749 CZC7080QJB 5175439 5175440 5175441 5175443 5175444 CZC5510Y65 5148390 5148391 CZC528244Z FRB4250QGD FRB4250SM9 CZC53003BV CZC5472F7Z CZC61544VW 5205308 5132683 5089742 6228600 CZC5521M4T CZC63128WV CZC6322Q84 CZC64006JD CZC64006JQ CZC64255CC CZC64511L2 CZC64511LR CZC64511LT CZC6482WLN CZC7080QJW CZC7364RSY CZC7364RVH 5225456 6111273 CZC5280BS9 CZC5391VDX CZC5492LJM CZC5510Y6H CZC5510Y6L CZC5521M4S CZC6425591 CZC642559R CZC642559S CZC7132V6N CZC7132V7N FRB4210XRY FRB426012M CZC6322Q7N 5199058 5182691 CZC5492LL4 5140816 5148401 5225428 5156082 5182700 5126772 5199066 5199070 5205303 5205771 5199053 5182719 6120283 6310167 CZC5240Q1K CZC5240Q1R CZC5240Q1S CZC528244Q CZC5282455 CZC5282456 CZC5282457 CZC528245F CZC528245P CZC53003B6 CZC53003BB CZC53003BM CZC53003BN CZC53003BP CZC53003BW CZC5391VDR CZC5391VDZ CZC5391VF6 CZC5391VFL CZC5391VFX CZC5391VGF CZC5460C7W CZC5462HVZ CZC5472F84 CZC5472F85 CZC5492LK1 CZC5492LKY CZC5492LLC CZC5521M43 CZC5521M4H CZC6030771 CZC61030GT CZC6130L2M CZC6130L34 CZC6130L36 CZC61544V8 CZC6181MTR CZC6261MW7 CZC6261MWD CZC6261MWP CZC6261MWX CZC63128WK CZC6322Q87 CZC6394DFT CZC64006JS CZC64006KG CZC64006KK CZC642558X CZC64255BQ CZC64511L3 CZC64511LF CZC64511M2 CZC64511M3 CZC64511M4 CZC7105QDS CZC7212G4F CZC7212G54 CZC7212G55 CZC721500P CZC7244NXH CZC7244NXK CZC7272RLW CZC7290DYD CZC7290DYH CZC7290DYM CZC7290DYQ CZC729ODZ4 CZC73312RS CZC7363P32 CZC7364RVB CZC7364RVG FRB4210XPX FRB4210XQJ FRB4210XQM FRB4210XS2 FRB4210XSH FRB4250SWR FRB4250SZ6 FRB4250SZ7 FRB4250T0Z FRB4260131 FRB426013W FRB426014M 5148402 5148403 5170750 5170758 5170759 5170761 CZC61030G0 CZC61030G5 CZC61030GF CZC5460C7J CZC642559Y CZC642889N CZC7364RRH CZC5472F80 CZC603076R CZC6030777 FRB4250SMB FRB4250SMD 5089747 CZC63128X4 CZC7105QDX CZC7105QFK CZC6391G9T CZC7080QJC CZC7105QFM CZC7363P3F FRB4250T0C 5205305 5156054 5165857 5165856 5199067 6048672 6161298 6279448 6315265 CZC6130L2V CZC61544W0 CZC61544V9 CZC61544VH CZC61544VL CZC61544VQ CZC61544VV CZC61544VY CZC6181MTV CZC6394DFY CZC6394DG4 CZC6394DG8 CZC6394DGH CZC6394DGK CZC6394DH0 CZC6394DH9 CZC64006K9 CZC64006KL CZC64006KR CZC64006KW CZC642558N CZC64511L6 CZC6482WK7 CZC6482WKX CZC6482WL3 CZC6482WLB CZC7105QF0 CZC7132V6T CZC7132V70 CZC7132V73 CZC7132V7K CZC7212G42 CZC73312RQ CZC73312RR CZC73312RW CZC7364RTR CZC7414GGT CZC7414GGZ 5089744 5126786 5213711 5182675 6004814 6049786 6049787 6061486 6061487 6061488 6061489 6061490 6061491 6061492 6095066 CZC5240Q1M CZC5280BS4 CZC5280BSF CZC5280BSM CZC5280BST CZC5282454 CZC5391VDV CZC5441LL0 CZC5462BV6 CZC5492LJV CZC5492LJZ CZC5510Y5W CZC5521M42 CZC5521M46 CZC5521M4P CZC5521M4Q FRB4250QG5 FRB4250QGR FRB4250QGY FRB4250QH3 FRB4250SWV FRB4250SWW FRB4250SZ9 FRB4250SZW FRB4250SZZ FRB4250T02 FRB4250T04 FRB4250T0M FRB426011Q FRB4260129 FRB426013N FRB426013Z FRB4260140 5171825 5199052 5199068 5129985 5175450 5175451 5175452 5182690 5225437 5225438 5100656 5213743 5222753 5205322 5205320 5140815 5156050 6111274 6111275 6228473 6228586 CZC5240Q1C CZC5391VFY CZC5391VG6 CZC5492LKT CZC5492LL6 CZC62803TH CZC7364RS5 FRB426014P 6061496 5089745 5089746 5089743 5205301 5175448 5170762 5170766 5171811 5171812 5182705 5182707 5182708 5182699 5182722 5199041 5199042 5182684 5222765 6004796 6065625 6095050 CZC5391VFQ CZC5391VFV CZC5391VG2 CZC5391VGD CZC5391VGJ CZC5460C7F CZC5460C7N CZC5460C7Q CZC5460C86 CZC5492LJX CZC5492LKC CZC5521M4M CZC5521M4Z CZC6130L2Y CZC6261MWC CZC63128WY CZC6322Q7R CZC64006KS CZC64006KY CZC642558Q CZC642559D CZC64255BW CZC7080QJ7 CZC7364RS9 CZC7414GGV CZC5240Q1D CZC5240Q1H 5182693 5165867 5171809 5165864 5165865 5165866 5205311 5148395 5148397 5205310 5132682 5225447 5148396 5182715 5182716 5182717 5199051 CZC5492LKB CZC5510Y5X CZC5521M4W CZC6181MTH CZC62803TN CZC6394D67 FRB4250SMJ CZC642558M CZC6425592 5182713 5170760 CZC551046P CZC7105QDV CZC7364RTW FRB4210XS1 FRB4250SZN FRB426012P FRB426012T CZC6425594 CZC5280BRW CZC5460C87 CZC5492LKL CZC6394DGG CZC642558P CZC6425597 CZC642559B CZC7080QJ8 CZC7080QK7 CZC603076N CZC61030G6 CZC6322Q7F CZC6322Q7K CZC6322Q7S 5165858 5225425 5213735 CZC7244NXM CZC7244NXQ CZC5472F88 CZC5472F8S CZC53003BK CZC6130L2H CZC6291WTN CZC63128WM CZC64511M0 5225441 CZC72414B3 CZC72414B6 CZC7250WNB CZC7364RRG CZC7364RTK 5175454 5225426 CZC53003B2 CZC53003B5 CZC5492LK4 CZC63128X1 CZC642559F CZC64255B1 CZC7105QF1 CZC724149T FRB4210XSD FRB4250SWZ FRB426011G FRB426013M 5213707 5140807 5156083 5225436 CZC7080QJM CZC7132V7P CZC7414GGC 5156274 5225442 5199047 5199069 5199071 5199072 5182677 5123580 5123581 5123579 5199043 5199044 5089740 5156280 5156273 CZC5280BSS CZC53003B1 CZC5460C7B CZC5462BTZ CZC6130L3C CZC64006L6 CZC642559Q CZC642559T CZC642559W CZC64255B6 CZC64255B9 CZC64255BD CZC64255BL CZC64255BV CZC64255C7 CZC7105QDR FRB4260120 FRB4260124 FRB4260125 FRB426013X CZC61030G4 CZC61030GD CZC61030H2 CZC64255BT CZC64255BY 5100641 5171823 CZC61544VD CZC61544VM CZC61544VZ CZC6261MWH CZC6322Q7Q CZC5240Q13 CZC5240Q14 5165854 5171820 5171821 5171822 5182683 CZC5492LL3 CZC7212G4J 5115306 CZC5460C85 CZC5462HW5 CZC72126A6 5205319 5205772 5205773 5205774 5205775 5170748 5170749 CZC7105QF2 CZC7105QF9 CZC7105QFD CZC7105QFJ 5156055 5156057 5170738 5175464 5175465 5213709 6064621 6064622 6064623 6064624 6064625 6064626 6064627 6064628 6064629 6064630 6064631 6064632 6064633 CZC5521M4K CZC61030GX CZC6130L3G CZC6181MT5 CZC6181MT9 CZC6181MTM CZC62803TC CZC62803TQ CZC62803TT CZC62803V0 CZC63128WD CZC63128WJ CZC63182WL CZC642558L CZC6425595 CZC642559V CZC64255C1 CZC64255CJ CZC64511LQ CZC73312RY CZC7364RRR CZC7364RTQ CZC7364RVD FRB4250SMF FRB4250SMH FRB4250SWS 5148392 5156049 5100633 5140822 5213747 5213746 5170744 5100643 5213749 CZC6383VVK CZC6391G9W CZC6391G9X CZC64006KN CZC64006KT CZC64006KV CZC64006L3 CZC72414B4 CZC7244NXD CZC7244NXP 5065158 5065159 5175445 5175446 5175447 5175449 5065157 5065156 5065152 CZC5280BS5 CZC5280BSK CZC5460C7Y CZC5462HW0 CZC5462HW8 CZC5462HVY CZC5472F8T CZC5492LJS CZC5521M44 CZC6130L2J CZC6130L2L CZC6130L2T CZC63128WF CZC63128WZ CZC63128X7 CZC63128X8 CZC63128XQ CZC64006JH CZC64255BC CZC64255BJ CZC64255C2 CZC64255CD CZC6482WKG CZC7105QDY CZC7105QF8 CZC7105QFB CZC7105QFQ CZC7132V72 CZC7212G50 CZC721500K CZC7244NX4 CZC7244NX8 CZC7244NXC CZC7250WNP CZC7414GHT CZC7364RSH CZC7364RSS CZC7414GGL 5148393 5156278 5156279 5156281 5199076 5199077 5199078 5199079 CZC7080QHY 5077167 5077168 CZC5460C7K CZC7105QFF 5140820 5140821 5175442 5065150 5213703 5156276 5065154 5065155 5225429 5225445 5077174 5140806 5126775 5065151 5199054 5126776 5126779 5182695 5077171 5156052 5156053 5156282 5156285 5225427 5182701 5156275 5170757 5065153 5140819 6120325 6161422 6197653 CZC528245K CZC5391VFC CZC5391VFG CZC5391VFR CZC5391VFW CZC5391VGN CZC5472F8L CZC5492LJY CZC5510Y5T CZC62803T5 CZC62803TL CZC62803TS CZC63128WW CZC6394DH7 CZC64006JK CZC64006JR CZC64006KM CZC642558J CZC6425599 CZC64255CH CZC64511LN CZC64511LS CZC64511M9 CZC7105QDP CZC7105QDT CZC7105QDZ CZC7105QFG CZC7105QFR CZC7105QFS CZC7132V7X CZC7212G4P CZC7212G4Q CZC7244NX5 CZC7244NXF CZC7364RSK CZC7364RSL CZC7364RSV FRB4250QH1 FRB426012S 5165861 5182712 5182714 5182694 5199064 5199065 5148389 CZC6482WJS CZC6482WKF CZC6482WLG CZC6482WLJ CZC7250WNN 5126781 5126782 5126783 5126784 and 5140824
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Wauwatosa ,  WI , 
Manufacturer: GE Healthcare Finland Oy, Helsinki , Finland . 
REASON GE Healthcare is providing information about two issues associated with iCentral L-NETO5 and L-NETC05 v4.3, 4.4, 4.5 and 5.0 when used in combination with Dash 2000, 3000, 4000 and 5000; Solar 7000, 8000, 8000M and 8000i; Eagle 3000 and 4000 and ApexPro. The iCentral does not provide audio or visual alarming for the following: A FIB, VT> and PVC(1) alarms when used with ApexPro and VT>2 and PVC (1) when used when used with Solar, DASH or Eagle (Cardiac Package software). The concern is that this issue may lead to delay in treatment.
VOLUME OF PRODUCT IN COMMERCE 2,146 units
DISTRIBUTION Nationwide and countries of Australia, Austria, Barbados, Belgium, Bolivia, Brasil, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Ecuador, Estonia, Finland, France, Georgia, Germany, Greece, Guatemala, Gayana, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Libyan Arab Jamahiriya, Macedonia, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Poland, Portugal, Qatar, Romania, Russia Federation, Saudi Arabia, Singapore, Slovak IA, South Africa, Sloven IA, South Korea, Spain, Sweden, Switzerland, Syria Arab Republic, Thailand, Tunas IA, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela and Yemen

PRODUCT
a) Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 4 inch length, sterile; REF 32-8105-027-04. The device is utilized for a total elbow arthroplasty surgical procedure, 
 
b) Zimmer Coonrad/Morrey Total Elbow, Interchangeable Humeral Assembly, extra small, 6 inch length, sterile; REF 32-8105-027-06. The device is utilized for a total elbow arthroplasty surgical procedure. 

c) Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, left, 3 inch length, sterile; REF 32-8105-043-01. The device is utilized for a total elbow arthroplasty surgical procedure, 
 
d) Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, right, 3 inch length, sterile; REF 32-8105-043-02. The device is utilized for a total elbow arthroplasty surgical procedure, 
 
e) Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, left, long, sterile; REF 32-8105-093-01. The device is utilized for a total elbow arthroplasty surgical procedure, 
 
f) Zimmer Coonrad/Morrey Total Elbow, Interchangeable Ulnar Assembly, plasma sprayed, extra small, right, long, sterile; REF 32-8105-093-02. The device is utilized for a total elbow arthroplasty surgical procedure, 
CODE All lots
RECALLING FIRM/MANUFACTURER Zimmer, Inc., Warsaw , IN , 
REASON The surgical technique is inadequate for extra-small sized implants, resulting in the possibility of the provisional becoming stuck in the bone.
VOLUME OF PRODUCT IN COMMERCE 14,613 units
DISTRIBUTION Nationwide and countries of Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Czech Republic, Denmark, England, Finland, France, Germany, Hong Kong, Hungary, India, Italy, Japan, Jordan, Latin America, Netherlands, Russia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey and Venezuela.

PRODUCT Dual Taper Wedge Pressed Fit Femoral Component. The Dual Taper Wedge is a single use device intended for pressed fit reconstruction of the femoral portion of severely disable and/or very painful hip joints resulting from osteoarthritis, rheumatoid arthritis, traumatic, arthritis or avascular necrosis where radiographic evidence of sufficient sound bone to seat the prosthesis is present. a) Part Number SC1439-0600; b) Part number SC1439-0700; c) Part number SC1439-0800; d) Part number SC1439-0900; e) Part number SC1439-1000; f) Part number SC1439-1125; g) Part number SC1439-1250; h) Part number SC1439-1375; i) Part number SC1439; j) Part number SC1439-1625; k) Part number SC1439-1750,
CODE
a) Lot numbers 8257-062904, 14298-0922705, 1740-091007, 14298-092705, 2256-110299, 4844-010302, 5447-072902, 6790-070803, and 8257-062904; b) Lot numbers 8258-062904, 16935-103006, 17874-061307, 1883-091007, 10559-040105, 16298-042606, 16935-103006, 2257-031199, 4845-101801, 6573-060303, 10559-040105, and 16935-103006; c) Lot numbers 19636-103006, 17875-043007, 19889-060208, 15910-013006, 16936-103006, 17875-043007, 4048-020701, 4418-071901, 5973-091202, 9776-102704, and 16936-103006; d) Lot numbers 16937-092506, 16301-042606, 16937-092506, 17876-071707, 10560-040105, 16301-042606, 16937-092506, 3201-110399, 3791-092000, 4617-102401, 6791-070803, 8487-071204, 14989-101205, and 16937-092506; e) Lot numbers 17610-032207, 14990-101005, 16166-050906, 16166-052206, 16306-082106, 17610-032207, 5260-062702, 7340-011204, and 16306-082106; f) Lot numbers 16938-092906, 17729-031907, 19152-042908, 20652-101308, 14991-091405, 15913-011806, 16439-050406, 16938-092906, 17729-031907, 2261-110299, 6113-111102, 6177-010703, 7341-090203, 15913-011806, and 17729-031907; g) Lot numbers 16839-082106, 8003-052504, 16939-102306, 17730-031907, 10563-040505, 15911-013006, 16839-082106, 16939-102306, 4420-1000901, 5006-040402, 6793-060303, 8003-052504, 16839-082106, and 16939-102306; h) Lot numbers 17731-031907, 17731-031907, 20654-092208, 10172-120604, 10564-041205, 14993-092605, 15912-013006, 17731-031907, 3794-121300, 15912-013006, and 17731-031907; i) Lot numbers 8025-052504, 19153-042908, 14299-092705, 1889-110299, 19153-042908, 5262-050202, 6306-021803, 8025-052504, 5262-050202, and 8025-052504; j) Lot numbers 1749-110299, 17120-022707, 1749-032007, 1749-110299, 2265-091499, 17120-022707, and 1749-110299; k) Lot numbers 1750-110299, 1169-091007, 1169-120406, 1649-030707, 1649-081307, 1649-091007, 1750-091007, and 1750-110299
RECALLING FIRM/MANUFACTURER Stelkast Co., Memurray , PA , .
REASON A possible breach of the sterile barrier packaging (Tyvek pouch).
VOLUME OF PRODUCT IN COMMERCE 187 units
DISTRIBUTION Nationwide

PRODUCT Sm ELISA Test System Product number 2Z2831G and Product number 43270CE Individual Enzyme-Linked Immunosorbent Assays for Antibodies to Jo-1, SM, SM/RNP, SSA, SSB and Scl-70. Semi-quantitative immunoassays for the detection of IgG antibodies to Jo-1, Sm, Sm/RPN (Ro), SSB(La) and Scl-70 in human sera. This device is for in-vitro diagnostic use,
CODE Lot number: 08041819, Exp. 11/2009; Lot number: 08041811, Exp. 11/2009
RECALLING FIRM/MANUFACTURER Zeus Scientific, Inc., Somerville , NJ 
REASON The Calibrator Value is printed incorrectly on the Sm ELISA Test System, lot # 08041819. The Calibrator Value (CV) printed on the label is 102; the correct CV should read 266.
VOLUME OF PRODUCT IN COMMERCE 33 units/lot # 08041819; 27 units/lot # 08041811
DISTRIBUTION Nationwide

PRODUCT ILED Surgical Light, Model numbers: ILED3, ILED5 and ILED5K, 
CODE Serial numbers: 100268621 to 100717475
RECALLING FIRM/MANUFACTURER
Recalling Firm: Trumpf Medical Systems, Inc., Charleston , SC , 
Manufacturer: Trumpf Kreuzer, Puchheim , Germany . 
REASON Cracks may form around the screw connections of the cover plates causing brittleness, which may lead to fragments breaking off and falling into the operating area.
VOLUME OF PRODUCT IN COMMERCE 4,480 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Stryker Electric Stretcher with the Quick Drop CPR option, Model 1050, 
 
b) Stryker Electric Stretcher with the Quick Drop CPR option, Model 1550, 
CODE
a) Serial numbers 94113214, 94113215, 94113216, 94113217, 94113218, 94113219, 94113220, 94113221, 94113222, 94113223, 94113224, 94113225, 94113226, 94113227, 94113228, 94113229, 94113230, 94113231, 94113232, 94113233, 94113234, 94083551, 94083552, 94083553, 94083554, 94083555, 94083556, 94083557 A, 94083558, 94113211, 9501031208, 9501031209, 9501031210, 9501031211, 9503032237, 9503032238, 9503032239, and 9503032240;
 
b) Serial numbers 93064826, 93094750, 93094765, 94023751, 94023753, 94023754, 94023755, 94023756, 94023757, 94023758, 94023759, 94023760, 94033751, 94033752, 94033753, 94033754, 94033759, 94043251, 94043252, 94043253, 94043254, 94043261, 94043262, 94043263, 94043264, 94043265, 94043266, 94043267, 94043268, 94043269, 94043270, 94043271, 94043272, 94043273, 94043274, 94043275, 94043276, 94043280, 94043281, 94043282, 94043283, 94043284, 94053651, 94053652, 94053653, 94053654, 94053659, 94053660, 94053684, 94053685, 94063501, 94063502, 94063503, 94063504, 94063505, 94063506, 94063507, 94063508, 94063509, 94063510, 94063511, 94063512, 94063513, 94063514, 94063515, 94063516, 94063517, 94063518, 94063519, 94063520, 94063521, 94063522, 94063523, 94063524, 94063525, 94063526, 94063527, 94063528, 94063529, 94063530, 94063531, 94063532, 94063533, 94063534, 94063535, 94073201, 94073202, 94073203, 94073204, 94073205, 94073206, 94073207, 94073208, 94073209, 94073210, 94073211, 94073212, 94073213, 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RECALLING FIRM/MANUFACTURER Stryker Medical Div. of Stryker Corp., Portage , MI , 
REASON The head section backrest (fowler) may not raise up, or , if up, may drop suddenly due to wearing out of the actuator threads on the fowler.
VOLUME OF PRODUCT IN COMMERCE 3,645 units
DISTRIBUTION Nationwide and Internationally
 
PRODUCT BEC Growth Chek Microbial Suspension - Candida albicans CA1 (100 dose), Product #10231-100 Liquid suspensions used for performing USP Growth Promotion and Bacteriostasis/Fungistasis testing and other quality control measures for growth media. Certified to deliver less than 100 organisms per dose, 
CODE Lot number: 121208, Expiration Date: 2-12-09
RECALLING FIRM/MANUFACTURER Lexamed, Toledo , OH 
REASON Candida albicans microbial suspension, certified to deliver less than 100 organisms per dose, was found to have a population count which exceeded 100 organisms per dose, following distribution.
VOLUME OF PRODUCT IN COMMERCE 1 vial
DISTRIBUTION UT

PRODUCT RELISA ENA Multiparameter Antibody Screening test, enzyme immunoassay test system; Kit catalog number: 7096-09 and kit catalog number: 7696-09, 
CODE Lot number: 0821407 and lot number: 0821404
RECALLING FIRM/MANUFACTURER Immuno Concepts, Inc., Sacramento , CA
REASON In certain patient samples, it is difficult to properly discriminate between anti-Sm/RMP positive samples and samples that are only anti-Sm positive.
VOLUME OF PRODUCT IN COMMERCE 25 kits
DISTRIBUTION Nationwide, Australia , England , Sweden and Austria

WEEK ENDING APRIL 4

PRODUCT
1) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782L. Sizes: 3 CM in length, REF (240) 27782L. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized. 
 
2) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782K. Sizes: 5.5CM in length, REF (240) 27782K. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
3) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782J. Sizes: 4.5 CM in length, REF (240) 27782J. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
4) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782H. Sizes: 11 CM in length, REF (240) 27782H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
5) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782G. Sizes 10cm in length, REF (240) 27782G. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
6) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782F. Sizes: 9 CM in length, REF (240) 27782F. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized,
 
7) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782E. Sizes: 8 CM in length, REF (240) 27782E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
8) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782D. Sizes: 7 CM in length, REF (240) 27782D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized,
 
9) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782C. Sizes: 6 CM in length, REF (240) 27782C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
10) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782B. Sizes: 5 CM in length, REF (240) 27782B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
11) Medtronic Innervision Snap Shunt Ventricular Catheter, BioGlide, Catalog Number 27782A. Sizes: 4 CM in length, REF (240) 27782 a. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
12) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27708A. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
13) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27708B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
14) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27708C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
15) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 7 CM, Ref 27708D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
16) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27708E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
17) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27708F. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
18) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9CM, Ref 27708G. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
19) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27708H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized,
 
20) Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27708J Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 

21) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 3 CM, Ref 27802A. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
22) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 4 CM, Ref 27802B. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
23) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 5 CM, Ref 27802C. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized,

24) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 6 CM, Ref 27802D. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, ;
 
25) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 7 CM, Ref 27802E. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
26) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 8 CM, Ref 27802F. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
27) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 9 CM, Ref 27802G. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
28) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 10 CM, Ref 27802H. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
 
29) Medtronic Snap Shunt Ventricular Catheter, Standard, with BioGlide, 11 CM, Ref 27802J. Each catheter is provided in a sealed Tyvek plastic tray placed within a sealed Tyvek/Mylar pouch. The sealed pouch is then placed within a chipboard carton along with product IFU and patient wallet cards. The product is ETO sterilized, 
CODE All lots
RECALLING FIRM/MANUFACTURER
Medtronic Neurosurgery, Goleta , CA , 
REASON
The ventricular catheters may become detached from the Snap Base assembly after implantation and this condition may increase the need for emergency revision surgery.
VOLUME OF PRODUCT IN COMMERCE
3,048 units
DISTRIBUTION Nationwide, Ireland and Australia

PRODUCT
a) Tri-State Centurion Chest Tube Insertion Tray, sterile, 6 per case; Reorder CHT620,
 
b) Tri-State Centurion Chest Tube Insertion Tray (Dentry/Bardmoor), sterile, 6 per case; Reorder CHT505, 
 
c) Tri-State Centurion PICC Line Tray, sterile, 10 per case; Reorder CVI2370, 
 
d) Tri-State Centurion PICC Insertion Tray, sterile, 15 per case; Reorder CVI2415A, 
 
e) Tri-State Centurion PICC/CVC Insertion Tray, sterile, 15 per case, Reorder CVI2490, 
 
f) Lee Medical Neonatal/Ped PICC Insertion Tray, sterile, 15 per case; Reorder CVI1025, 
 
g) Tri-State Centurion Port Access Kit, sterile, 20 per case; Reorder KNV35, 
 
h) Tri-State Centurion Port Access Tray, sterile, 20 per case; Reorder DT4825, 
 
i) Tri-State Centurion Port Access Tray, sterile, 20 per case; Reorder DT5245,
 
j) Tri-State Centurion Port Access Tray, sterile, 20 per case; Reorder KNV75, ;
 
k) Tri-State Centurion Implanted Access Port Tray, sterile, 16 per case; Reorder DT7105,
 
l) Tri-State Centurion Sutureless Multi-Lumen CVC Insertion Kit, sterile, 5 per case, Reorder ECVC175, 

m) Tri-State Centurion Umbilical Vessel Tray without catheter, sterile, 5 per tray; reorder UVT 170, 
CODE
a) Lot 2008111350;
b) Lot 2008111350;
c) Lot 2008111050;
d) Lot 2008111150;
e) Lot 2008111850;
f) Lot 2008111750;
g) Lot 2008111150;
h) Lot 2008110250;
i) Lot 2008111250;
j) Lot 2008111450;
k) Lot 2008111650;
l) Lot 2008111250;
m) Lot 2008111050
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tri-State Hospital Supply Corp., Howell , MI , 
Manufacturer: Tri-State Hospital Supply Corp., Salisbury , NC . 
REASON
Lack of assurance of sterility, as the package seals may be inadequate.
VOLUME OF PRODUCT IN COMMERCE
1,736 devices
DISTRIBUTION Nationwide
 
PRODUCT Roche COBAS c 111 Analyzer with ISE module option, GMMI No. 04777433001; Is an in-vitro diagnostic analyzer capable of performing clinical chemistry, specific protein electrolyte tests. Analytes are measured photometrically or turbidimetrically. The analyzer also has an optional ISE module for measuring sodium, potassium and chloride, CODE
Serial numbers: 50654, 50694, 50541, 50634, 50251, 50506, 50453, 50688, 50244, 50475, 50597, 50656, 50598, 50635, 50632, 50586, 50320, 50246, 50693, 50692, 50562, 50547, 50624, 50690, 50687, 50680, 50560, 50247, 50538, 50633, 50201, 50612, 50576, 50689, 50681, 50424, 50651, 50661, 50452, 50450, 50290, 50630, 50319, 50250, 50549, 50682, 50683, 50685, 50660, 50545, 50463, 50655, 50539, 50653, 50249, 50563, 50561, 50686, 50649, 50470, 50657, 50448, 50644, 50595, 50575, and 50679
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis ,  IN 
Manufacturer: Roche Instrument Center AG, Rotkreuz , Switzerland
REASON
Due to a manufacturing error at the supplier, not all cobas c 111 pinch valve caps are properly glued to the correct position on the pinch valve shaft. Without the glue, the cap can become loose or misaligned. The effect of these faulty valves is that they may not open or close properly which can disturb the fluid transportation within the ISE module resulting in problems with ISE calibration, controls and/or sample results. Inaccurate and unflagged results may be generated and a wrong diagnosis due to incorrect results cannot be excluded.
VOLUME OF PRODUCT IN COMMERCE
66 devices
DISTRIBUTION Nationwide

PRODUCT QCA and iQCA software, a video microscopy software system for quantitative estrogen receptor immunohistochemistry; Cell Analysis Inc., Evanston, IL 60201 or Highland Park, IL 60035. Intended to measure and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed, paraffin-embedded tissue specimens immunohistochemically stained for estrogen receptors. Indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer when used with reagents validated for those indications, 
CODE
All software versions 3.7 and above.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leica Microsystems, Inc., Bannockburn , IL , 
Manufacturer: Vision Biosystems, Mount Waverley , Australia . 
REASON
A change in the software to open up the software architecture to include other analytes other than Estrogen Receptor was made without FDA review and approval.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION Nationwide

PRODUCT Bio-Rad Variant II TURBO Hemoglobin Testing System with CDM v 4.0, model number 270-2600. Provides an integrated method for sample preparation, separation and the percent determination of percent hemoglobin A 1 c in EDTA human whole blood. This device only tests for A 1 c, 
CODE
Version 4.0 software
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Inc., Hercules, CA,
REASON
Sample results may be assigned to the wrong barcode number and tube position numbers, leading to discrepant sample results.
VOLUME OF PRODUCT IN COMMERCE
92 devices
DISTRIBUTION
Nationwide and countries of Argentina, Australia, Brazil, Canada, Chile, China, Colombia, France, Germany, Hong Kong, Hungary, India, Italy, Mexico, New Zealand, Singapore, South Korea, Sweden, Taiwan and the UK

PRODUCT DiaSorin LIAISON (R) Chemiluminescence Analyzer Model # 15970. Colorimeter, Photometer, Spectrophotometer for clinical use, 
CODE
Serial numbers: 2229000828, 2229000829, 2229000839, 2229000857, 2229000859, 2229000926, 2229000972, 2229001196, and 2229001230
RECALLING FIRM/MANUFACTURER
Recalling Firm: DiaSorin, Inc., Stillwater , MN
Manufacturer: Stratec Biomedical Systems AG, Birkenfeld , Germany . 
REASON
DiaSorin determined that there was a potential for a short to occur in a residual starter pump electrical cable in the LIAISON ® Analyzer.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION Nationwide and Canada

PRODUCT Stryker Impaction Bur Guard REF 2296-301, 2296-300, 0260-901-300, & 5400-300; Intended to be used with impaction Drill. Drill is used for surgical procedures involving precision drilling and cutting of bone and hard tissue. The bur guard covers the nose of the handpiece and the shaft of the cutting accessory to prevent exposure to heat and moving parts, as well as minimize bur whip and handpiece vibration. 
CODE
Any hand pieces repaired and returned from 9/18/08 to 10/10/08 may have the recalled bur guards. Serial Numbers: 0414100533, 0414100563, 0509100113, 0509100153, 0723404443, 0719104803, 98030843, 0318200043, 0727604043, 0729800243, 98061133, 0329401103, 97060133, 0424700493, 95022553, 0225501513, 0326900083, 99020483, 0330800593, 96010273, 0318200013, 97010813, 0324102133, 96050103, 0225501563, 99050023, 94091003, 97060223, 97060243, 97060613, 97080253, 98080163, 98050533, 98020403, 0533401073, 97050523, 0428800503, 0713801143, 0633303273, 96070353, 0311401713, 00120423, 99050053, 01020103, 02010803, 96120423, 99090353, 0233004783, 98061203, 99090293, 99110863, 0428202963, 0624803663, 0719000333, 94121523, 99100013, 94080453, 97050833, 96090533, 97120983, 97120993, 99111173, 0726300403, 0726300413, 01070163, 01070173, 0409604363, 0418005013, 0528001463, 99010543, 0511800053, 0511800083, 0709208133, 98050813, 00020373, 97020173, 99100123, 97050823, 01040533, 0228902373, 0231700673, 99070473, 0313302433, 99010903, 0819605873, 95040843, 94120653, 0715001683, 95021513, 95021523, 98010663, 0230100243, 98100133, 99100073, 0713123243, 0415500963, 95011113, 0726708833, 95030323, 0230100233, 99090493, 00080073, 95100103, 95100113, 0230200313, 97040563, 99070123, 0316200853, 94090983, 00110113, 94111083, 99010683, 97110023, 98120993, 00030153, 0512301433, 94100163, 94121103, 94121113, 98010673, 96110383, 97110453, 0330700333, 97121623, 98100863, 0414900263, 0232500443, 95022133, 0414100543, 0414100553, 0414100613, 0509100133, 0723404483, 98111233, 95100203, 0734700603, 00080083, 98050053, 00120433, 99040403, 99100113, 0309902613, 0808801833, 0233801463, 0721406933, 94121903, 99080283, 0731614433, 0608304673, 0609004613, 0611506303, 0611506313, 0613003513, 0613003533, 0525500823, 96120233, 95110333, 0417601883, 0618101713, 0624205473, 94090153, 98120473, 97100113, 0233900963, 00100793, 00030163, 0225600983, 0231000193, 96020173, 95030143, 01090313, 0606604453, 0334600733, 98050113, 0231800503, 94120733, 94050013, 0715001663, 94122153, 95030993, 95120103, 94110683, 0635406433, 98081583, 99020373, 94070313, 99111033, 0315500203, 96070313, 0535500863, 0632200223, 0417601873, 0400500163, 0631003513, 97080383, 0621206363, 02010793, 0401402363, 0336400963, 0330901153, 0229100103, 0508201013, 0634605013, 0635406413, 95100603, 00060133, 0530602873, 98011083, 98021223, 97111273, 98120113, 97030263, 97050393, 97020163, 99100253, 97090053, 00040293, 0703902843, 0707903723, 97050563, and 97090943
RECALLING FIRM/MANUFACTURER
Stryker Instruments, Div. of Stryker Corp., Portage , MI , 
REASON
Bur guards were distributed without an expiration date, and if they are used after they have expired it could result in the patient or operating room staff experiencing a burn or laceration.
VOLUME OF PRODUCT IN COMMERCE
70 units
DISTRIBUTION Nationwide

Tri-State Hospital Supply Corporation, Centurion Brand Trays and Kits

Tri-State Hospital Supply Corporation notified healthcare professionals of a recall of multiple types of Centurion brand disposable trays and kits used for insertion of tubes, catheters and ports, due to package sealing that may effect the sterility of the devices. These products were distributed from November 24, 2008 through January 7, 2009. Distributors and customers were instructed to remove the products from their inventory, inform the company of the number of products in stock and hold the products until the company arranges for their return.