JULY 2008
WEEK ENDING JULY 5
PRODUCT
Access Ultra sensitive Insulin Assay Kit, Part Number 33410. The product is a
paramagnetic particle, chemiluminescent immunoassay for the quantitative
determination of insulin levels in human serum and plasma (EDTA) using the
Access Immunoassay Systems,
CODE Lot Numbers: 714362 (Exp.
3/31/09), 716129 (Exp. 6/30/09), 718258 (Exp. 7/31/09), 519096 (Exp. 10/31/07),
521487 (Exp. 2/28/08), 616274 (Exp. 7/31/08), 617890 (Exp. 7/31/08), 617891
(Exp. 7/31/08) and 620204 (Exp. 12/31/08)
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Beckman Coulter, Inc., Brea, CA,
Manufacturer: Beckman
Coulter, Inc., Chaska, MN.
REASON False negative results
when used to test serum samples (as compared to plasma samples).
VOLUME
OF PRODUCT IN COMMERCE 8,537 kits
DISTRIBUTION
Nationwide and Internationally
PRODUCT S/5 iCentral,
Cardiovascular Monitoring Devices, Versions L-NET03, L-NETC03, L-NET05 and
L-NETC05, CODE
CZC7244NXM CZC5510Y6G CZC61030GC CZC5492LL2
5100648 5100649 5100650 5100651 5100653 5100654 5100655 5115314 5123573 5123574
5123575 5123578 5132670 5132671 5132672 5132673 5132674 5132675 5132676 5132677
5132678 5132679 5132680 5132681 5140814 5148398 5148399 5148404 5148405 5148406
5148407 5148408 5156075 5156076 5156077 5156078 5156079 5156080 5156081 5156284
5165853 5165868 5171824 5173135 5178892 5178893 5178894 5178895 5178896 5178898
5178899 5178900 5182706 5182709 5182710 5182711 5182718 5199055 5199063 5199080
5205776 5205777 5213714 5213715 5213716 5213717 5213718 5213719 5213720 5213721
5213722 5213723 5213724 5213725 5213727 5213728 5213729 5213730 5213731 5213732
5213733 5213734 5213741 6004804 6161335 6161447 6186167 6299938 6315252
C2C528245B CZC5240Q16 CZC5240Q18 CZC5240Q1G CZC5240Q1J CZC5240Q1L CZC5240Q1Q
CZC5280BS7 CZC5280BSD CZC528244Y CZC528245B CZC53003B3 CZC53003B8 CZC53003B9
CZC53003BQ CZC53003BR CZC53003BX CZC5391VDQ CZC5391VF4 CZC5391VFJ CZC5391VFS
CZC5391VG5 CZC5391VGL CZC5472F8J CZC5492LJQ CZC5492LK5 CZC5492LKS CZC5492LLD
CZC5492LLH CZC5492LLM CZC5510Y60 CZC5510Y63 CZC5510Y64 CZC5510Y6B CZC5510Y6J
CZC5510Y6M CZC5510Y6N CZC61030G8 CZC61030GH CZC61030H0 CZC6130L2N CZC6130L2P
CZC6130L2S CZC6130L30 CZC6130L3B CZC6130L3F CZC6181MSZ CZC6181MT0 CZC6181MT1
CZC6181MT8 CZC6261MW4 CZC6261MW5 CZC6261MWM CZC6261MWT CZC6261MWZ CZC62803TK
CZC62803TR CZC6291WTP CZC6291WTR CZC63128WC CZC63128WT CZC63128X5 CZC6322Q7L
CZC6322Q85 CZC6322Q88 CZC6394DFG CZC6394DGV CZC64006JT CZC64006JY CZC64006K3
CZC64006KB CZC642559H CZC642559M CZC642559Z CZC64255BK CZC64255BX CZC64511L8
CZC64511LK CZC6482WKB CZC6482WKL CZC6482WKM CZC6482WKT CZC6482WKY CZC7132V6M
CZC7132V6P CZC7132V6V CZC7132V76 CZC7132V79 CZC7132V7D CZC7132V7Z CZC7132V80
CZC7132V83 CZC7212G4K CZC7212G51 CZC7212G52 CZC7215009 CZC721500C CZC721500D
CZC721500M CZC721500R CZC721500T CZC7215010 CZC72414B9 CZC7244NXG CZC7244NXJ
CZC7250WNJ CZC7272RLH CZC7272RLS CZC7272RM2 CZC7272RM6 CZC7290DYF CZC7290DZ1
CZC73312RZ CZC7363P2Z CZC7363P3M CZC7364RTL CZC7364RV2 CZC7364RV6 CZC7414GGD
CZC7414GJH FRB4210XQ9 FRB4210XQZ FRB4210XSV FRB4250QGW FRB4250SM6 FRB4250SM8
FRB4250SZY FRB4250T0D FRB4250T0H FRB4250T0Q FRB4250T10 FRB4250T11 FRB4260139
CZC5492LLJ CZC7244NXQ CZC5391VF7 5100635 5100637 5100640 5100652 5115311 5126769
5126770 5140808 5148400 5170751 5170752 5199050 5205317 5213739 5225432 5225433
6120270 CZC5240Q12 CZC5240Q15 CZC5240Q19 CZC5240Q1B CZC5460C82 CZC5462HW6
CZC6030779 CZC6130L37 CZC6181MTD CZC6181MTG CZC6181MTS CZC6181MTT CZC6181MTY
CZC62803T3 CZC62803TG CZC62803TX CZC6322Q86 CZC6394DG6 CZC64255C5 CZC7080QKF
CZC7132V7S CZC7132V7Y CZC7212G4Y CZC7212G53 CZC721500Y FRB4250T0F FRB426012Z
CZC528244Z CZC603077D CZC61030GC 5077175 5126785 5132684 5156286 5156287 5156288
5156289 5156290 5165839 5165840 5165841 5165842 5165843 5165844 5165845 5165846
5165847 5165848 5165849 5165850 5165851 5165852 5175459 5175467 5175468 5182673
5182692 5182696 5199062 5205307 5205316 5205321 5205323 5205329 5205780 5213738
5222755 5225444 5225448 6111282 6111283 6161279 6161280 6161281 6161302 6161303
6161318 6161319 6161320 6161321 6161334 6161354 6161355 6161356 6161357 6161358
6161359 6161361 6161362 6161363 6161364 6161365 6161366 6161367 6161368 6161369
6161370 6161371 6161372 6161373 6161374 6161375 6161376 6161377 6161392 6161393
6161394 6161395 6161396 6161397 6161398 6161399 6161400 6161401 6161402 6161403
6161404 6161405 6161406 6161407 6161408 6161409 6161410 6161411 6161412 6161413
6161414 6161415 6161416 6161427 6161437 6161446 6186166 6186171 6197698 6203596
6203824 6269008 6315249 CZC5240Q10 CZC5240Q17 CZC5240Q1Y CZC5240Q20 CZC5280BRZ
CZC5280BS1 CZC5280BS8 CZC5280BSG CZC5280BSH CZC5280BSP CZC5280BSV CZC5282452
CZC5282458 CZC528245D CZC530039Z CZC53003B0 CZC53003BD CZC53003BT CZC53003BY
CZC5391VDY CZC5391VF5 CZC5391VF8 CZC5391VG0 CZC5391VG1 CZC5391VG7 CZC5391VG8
CZC5391VGB CZC5391VGH CZC5391VGM CZC5391VGS CZC5460C7X CZC5460C7Z CZC5462BV2
CZC5462BV9 CZC5472F7T CZC5472F8G CZC5492LK8 CZC5492LKD CZC5492LKG CZC5492LKQ
CZC5492LKW CZC5492LL5 CZC5510Y5Q CZC5510Y5R CZC5510Y5S CZC5510Y69 CZC5510Y6D
CZC61544W1 CZC6181MT6 CZC6261MW1 CZC6261MW6 CZC6261MWG CZC6261MWJ CZC6261MWL
CZC6261MWQ CZC6261MX1 CZC62803TZ CZC63128WG CZC63128WX CZC6322Q7H CZC6394DGQ
CZC6394DHC CZC64006JV CZC64006JX CZC64006K4 CZC6425587 CZC6425590 CZC64255B2
CZC64255B8 CZC64255BG CZC64255BP CZC64255BS CZC64255C8 CZC64255C9 CZC64255CF
CZC64511LL CZC6482WJZ CZC6482WK2 CZC6482WK9 CZC6482WKJ CZC7080QJ2 CZC7080QJ9
CZC7080QJF CZC7080QJN CZC7080QJT CZC7080QK9 CZC7132V7C CZC7132V81 CZC7132V82
CZC7212G4S CZC7212G4X CZC721500Z CZC7244NXT CZC7250WN9 CZC7250WNF CZC7290DYG
CZC7290DYS CZC73312RB CZC7364RRL CZC7364RRM CZC7364RRV CZC7364RS8 CZC7364RSN
CZC7364RTT CZC7364RTY CZC7414GGR FRB4210XRC FRB4210XRR FRB4210XSP FRB4210XSY
FRB4210XSZ FRB4250SM5 FRB4250SMG FRB4250SWT FRB4250T0P FRB426011S FRB426012C
FRB4260133 FRB426013Q CZC6261MWB CZC6261MWY 5100628 5100642 5100644 5100645
5115308 5115310 5123582 5123586 5123587 5126768 5126773 5156048 5156074 5156283
5165855 5165860 5171810 5199048 5205306 5213742 5213748 5222752 6111290 6255417
6327416 CZC5240Q1T CZC528244S CZC528245H CZC528245J CZC5391VFB CZC5391VG4
CZC5492LJL CZC5492LK2 CZC5492LKF CZC5492LKV CZC5492LL8 CZC5521M4D CZC6130L2R
CZC62803T8 CZC62803TF CZC62803TP CZC6383VV6 CZC6383VVF CZC6383VVH CZC6383VVJ
CZC6394DGR CZC6394DGS CZC6425596 CZC64255B4 CZC64511LH CZC6482WLF CZC7132V6Z
CZC7272RLT CZC7272RLZ CZC7272RM0 CZC73312S0 CZC7364RRN CZC7414GGW FRB4210XS8
CZC5492LK6 5225446 6203582 CZC5521M47 CZC5521M50 CZC6103069 CZC61030GL
CZC6130L3D CZC6261MWF CZC64511LX CZC6482WKP CZC7080QKD CZC721500G CZC721500H
CZC721500J CZC724149X CZC72414B7 CZC72414BI CZC7250WN8 CZC7272RM7 CZC7290DYK
CZC7290DYL CZC7290DYT CZC7290DYY CZC73312RF CZC73312RP CZC7363P37 5182681
5182682 5225439 5225440 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 5126787 5170740 5170741 5170743 5175466 5205326 5205327 5205328
5222754 6022570 6030463 CZC5391VFK CZC5492LL9 CZC5521M48 CZC601030GK CZC6228603
CZC64255CB CZC6482WJV CZC7080QJL CZC7080QJZ CZC7364RTP FRB4250QG3 6061493
6061494 6061495 CZC6261MW9 CZC721500B CZC7364RV9 CZC6394DGP CZC6394DGY 6303248
CZC6322Q81 CZC721500Q CZC64006K0 5077170 5077172 5100630 5100647 5126777 5126778
5126780 5182680 5199046 6061497 6061498 6061499 6061500 6061501 6061502 6061503
6061504 CZC5462HW1 CZC5521M4F CZC5521M4J CZC61030GB CZC61030GJ CZC61030GN
CZC61544VB CZC7080QJV CZC7080QK0 CZC7290DZ0 CZC7290DZZ CZC73312RJ CZC7364RTJ
FRB4250QGV 5100646 5140809 5140810 5140811 5140812 5170737 5170739 5199061
6161315 6161428 CZ6394DFW CZC5240Q11 CZC61544V4 CZC61544VK CZC6181MTJ CZC6394DFZ
CZC6394DGL CZC7212G4R CZC7364R5C FRB4210XQN CZC7132V7F 5077173 5100631 5100632
5199045 CZC5391VF2 CZC64006J CZC64006JC CZC64006K1 CZC7132V7T CZC7132V7W
CZC7244NXM CZC7244NXQ CZC5472F80 CZC5472F88 CZC5472F8Q CZC5472F8S CZC6030776
CZC603077B CZC603077D CZC721500W 5100636 5100638 5100639 5126771 5140805 5170754
5170755 5175457 5205324 6049777 6049778 6049779 6049781 6049782 6049783
CZC5280BSQ CZC53003B7 CZC5462BTX CZC5462BV4 CZC5472F8R CZC5492LJR CZC5492LL1
CZC5492LLL CZC5521M41 CZC603076Z CZC6030770 CZC6030773 CZC61030GY CZC6181MTF
CZC6261MWR CZC63128WQ CZC63128WS CZC6394DGC CZC6394DHF CZC64006JG CZC642559G
CZC64255BB CZC64255CL CZC64511L7 CZC64511M1 CZC64511M7 CZC6482WL5 CZC7080QJS
CZC7105QF7 CZC7132V7R CZC713ZV7V CZC721500X CZC7364RRQ CZC7364RRZ CZC7364RST
CZC741446L8 CZC7414GLJ CZC7414GLQ FRB4250SXV CZC5280BSJ CZC6030776 5115300
5115301 5115302 5115303 5115304 5115305 5115307 5170742 5170765 5171813 5171814
5171815 5171819 5171828 5175455 5175456 5175463 5182674 5182687 5182689 5182702
5182703 5182704 5199073 5199074 5199075 5205304 5205312 5205313 5205314 5205315
5205325 5213704 5213705 5213710 5213712 5213713 5225443 5225449 5225452 5225453
5225454 5225455 6186155 6203600 6203601 6255626 6255644 6307438 6315245 6332990
CZC5240Q1P CZC5240Q1X CZC5240Q1Z CZC53003BF CZC53003BS CZC5391VDP CZC5391VFH
CZC5391VFZ CZC5391VG9 CZC5462BTR CZC5492LK7 CZC5492LL7 CZC603076S CZC61030GR
CZC61030GW CZC6130L2Z CZC61544V1 CZC61544VP CZC6261MW2 CZC6261MW3 CZC6261MW8
CZC6261MWW CZC6261MX0 CZC62803T1 CZC62803T7 CZC62803TM CZC62803TV CZC6322Q7P
CZC6322Q7T CZC6322Q7V CZC6322Q7Y CZC6322Q89 CZC6394DFS CZC6394DGN CZC6394DGT
CZC64006JM CZC64006JP CZC64006K5 CZC64006K7 CZC642558R CZC642558S CZC6425593
CZC642559J CZC64255C6 CZC64511L1 CZC64511L5 CZC64511LB CZC64511LC CZC64511LM
CZC64511LP CZC64511LW CZC6482WJY CZC6482WK0 CZC6482WKC CZC6482WKH CZC6482WKQ
CZC6482WKR CZC6482WL1 CZC6482WL2 CZC6482WL6 CZC6482WL8 CZC6482WL9 CZC6482WLL
CZC7080QJ4 CZC7080QJD CZC7080QJY CZC7080QK1 CZC7080QK2 CZC7080QK4 CZC7080QKC
CZC7105QF3 CZC7132V7B CZC7212G4L CZC724149V CZC7241EB2 CZC7244NXN CZC7244NXV
CZC7250WN2 CZC7250WN7 CZC7250WNC CZC7250WNM CZC7272RM1 CZC7290DYJ CZC7290DYV
CZC7290DYW CZC7290DZ3 CZC73312R9 CZC73312RK CZC73312RT CZC73312RV CZC7363P2X
CZC7363P2Y CZC7363P3B CZC7363P3D CZC7364RRT CZC7364RTM CZC7364RV1 CZC7364RVJ
CZC7414GGH CZC7414GGK CZC7414GLF CZC7414GLR FRB3470CPW FRB4210XS6 FRB4250QH0
FRB4250SMC FRB4250SZX FRB4250T0S FRB4250T0T FRB4250T12 FRB426014N CZC64006JF
CZC64255BZ CZC64255C4 CZC5391VF7 CZC603077B CZC6181MTB CZC64006K0 CZC721500W
5077178 5077179 5115312 5115313 5123576 5123577 5171816 5171817 5171818 5175458
5175460 5175462 5182685 5182686 5182688 5199049 5199059 5199060 5205778 5205779
5213702 5213706 5213737 5213745 6004799 6022584 6048665 6120246 6120266 6226668
6295136 6307432 6309945 6315267 6333017 C2C5462BV5 CZC132V6W CZC5240Q1N
CZC5240Q1V CZC5280BRV CZC5280BRY CZC5280BS2 CZC5280BS6 CZC5280BSB CZC5280BSC
CZC528244T CZC5282450 CZC5282453 CZC528245G CZC528245N CZC530039Y CZC5391VDW
CZC5391VFM CZC5391VFP CZC5391VFT CZC5460C7P CZC5460C81 CZC5462BTS CZC5462BTT
CZC5462BTW CZC5462BTY CZC5462BVB CZC5462HW4 CZC5462HW7 CZC5462HVX CZC5472F7V
CZC5472F81 CZC5472F89 CZC5472F8F CZC5472F8N CZC5492LJN CZC5492LJW CZC5492LK0
CZC5492LKP CZC5492LKZ CZC5492LLG CZC5510Y5V CZC5510Y5Z CZC5510Y6Q CZC603076Q
CZC603076V CZC603076X CZC6030775 CZC6030778 CZC61030G2 CZC61030G3 CZC6130L2K
CZC6130L31 CZC6130L38 CZC6130L3H CZC61544V3 CZC61544VG CZC6181MSY CZC6181MTC
CZC6261MWV CZC62803T0 CZC62803T6 CZC62803T9 CZC6291WTH CZC6291WTQ CZC63128W8
CZC6322Q7X CZC6394DFR CZC6394DFV CZC6394DG2 CZC6394DGB CZC6394DGJ CZC6394DGM
CZC6394DGW CZC6394DGX CZC6394DH6 CZC6394DHB CZC64006L5 CZC642558K CZC642558T
CZC642558Y CZC642559X CZC64255BN CZC64255BR CZC64255C0 CZC64255C3 CZC64255CG
CZC64511L4 CZC64511L9 CZC64511LD CZC64511LY CZC64511M6 CZC6482WJX CZC6482WKZ
CZC7080QHX CZC7080QJ0 CZC7080QJ3 CZC7080QJ5 CZC7080QJ6 CZC7080QJG CZC7080QJJ
CZC7080QK6 CZC7080QK8 CZC7105QF4 CZC7105QF6 CZC7105QFL CZC7132V6Q CZC7132V6R
CZC7132V6Y CZC7132V75 CZC7132V7G CZC7132V7H CZC721500S CZC721500V CZC724149W
CZC72414B8 CZC72414BB CZC72414BC CZC72414BD CZC72414BF CZC72414BQ CZC7244NXR
CZC7250WMZ CZC7250WN0 CZC7250WN3 CZC7250WN4 CZC7250WN6 CZC7250WND CZC7250WNG
CZC7250WNH CZC7250WNK CZC7250WNL CZC7272RLV CZC7272RM3 CZC7290DYN CZC7290DYR
CZC7290DYZ CZC7363P35 CZC7363P39 CZC7363P3H CZC7364RS3 CZC7364RSB CZC7364RSF
CZC7364RTG CZC7364RV3 CZC7364RVF CZC741466M CZC7414GGF CZC7414GGN CZC7414GJ2
FRB4210XQ5 FRB4210XRT FRB4250QG4 FRB4250QGP FRB4250QGX FRB4250SWY FRB4250T07
FRB4250T0W FRB4250TOL FRB426011K FRB4260138 5077176 5077177 5182720 6186143
CZC5510Y66 CZC61030GV CZC6130L2W CZC6181MTK CZC6322Q8D CZC6482WLH CZC6482WLK
CZC7105QFC CZC7132V7M CZC724149S CZC724149Z CZC7414GGP CZC61030GP CZC6130L35
CZC61544V5 CZC7105QFT FRB4250SWX 5089748 5089749 5100629 5100657 5225450
CZC5472F7X CZC5472F7Y CZC5472F83 CZC5472F86 CZC5472F8C CZC5472F8H CZC7080QJB
CZC5280BSJ CZC5472F8Q 5123583 5123584 5123585 5140823 5148394 5170764 5175453
5205300 5205302 5213751 5225431 6228609 CZC5280BS0 CZC5280BSL CZC5280BSN
CZC5462BV8 CZC5462BVC CZC5510Y61 CZC5521M4G CZC603077C CZC6181MT2 CZC7363P36
FRB4250SZ0 FRB4250SZV FRB4250T0K FRB4250T0R CZC528244Z 5148390 5148391 5175439
5175440 5175441 5175443 5175444 CZC5510Y65 FRB4250QGD FRB4250SM9 5089742 5132683
5205308 5225456 6228600 CZC53003BV CZC5472F7Z CZC5521M4T CZC61544VW CZC63128WV
CZC6322Q84 CZC64006JD CZC64006JQ CZC64255CC CZC64511L2 CZC64511LR CZC64511LT
CZC6482WLN CZC7080QJW CZC7364RSY CZC7364RVH 5140816 5148401 5182691 5199058
5225428 6111273 CZC5280BS9 CZC5391VDX CZC5492LJM CZC5492LL4 CZC5510Y6H
CZC5510Y6L CZC5521M4S CZC6322Q7N CZC6425591 CZC642559R CZC642559S CZC7132V6N
CZC7132V7N FRB4210XRY FRB426012M 5126772 5148402 5148403 5156082 5170750 5170758
5170759 5170761 5182700 5182719 5199053 5199066 5199070 5205303 5205771 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
CZC6181MTB CZC6425594 5100634 5115309 5129989 5140813 5156291 5165863 5171826
5171827 5175461 5199056 5199057 5205309 6203592 6255652 6279447 6299949
CZC5391VGK CZC5472F87 CZC603076G CZC603076J CZC603076L CZC603076W CZC6030774
CZC61544V6 CZC61544VF CZC6181MTX CZC62803T4 CZC63128WH CZC6394DGZ CZC64006JN
CZC64006K6 CZC64006KP CZC64006L9 CZC64255CK CZC6482WJR CZC6482WJT CZC6482WK1
CZC6482WKD CZC7080QJK CZC7080QJP CZC7212G4H FRB4210XQX FRB4210XR1 FRB4210XS7
FRB4250T0J CZC5472F80 CZC5460C7J CZC603076R CZC6030777 CZC61030G0 CZC61030G5
CZC61030GF CZC642559Y CZC642889N CZC7364RRH CZC5280BSR CZC53003B4 CZC5460C7H
CZC5460C7M CZC5460C7R CZC5460C7S CZC5460C7T CZC5460C7V CZC5460C80 CZC5460C83
CZC5460C84 CZC5460C88 CZC5460C89 CZC5472F82 CZC5472F8B CZC5472F8D CZC5472F8P
CZC5492LL0 CZC5492LLB CZC63128W9 CZC63128WP CZC6394DGF CZC64006K8 CZC64006KH
CZC6482WLD CZC7302PJX CZC73312RD 5089747 CZC63128X4 CZC7105QDX CZC7105QFK
FRB4250SMB FRB4250SMD CZC6391G9T CZC7080QJC 5205305 CZC7105QFM CZC7363P3F
FRB4250T0C CZC6425598 CZC64511LZ CZC7364RTV CZC5492LL2 999999.01 999999.02
999999.03 999999.04 5170753 5213740 CZC52303S6 CZC52303S8 CZC528244V CZC53003BC
CZC53003BH CZC53003BJ CZC5391VF3 CZC5462BV7 CZC5492LJP CZC5492LKR CZC5492LKX
CZC5510Y5Y CZC5521M40 CZC5521M45 CZC5521M49 CZC5521M4B CZC5521M4C CZC5521M4R
CZC5521M4V CZC5521M4X CZC5521M4Y CZC61030GM CZC6130L2X CZC6181MT7 CZC6261MWS
CZC62803TD CZC62803TJ CZC62803TW CZC63128WB CZC63128WN CZC63128WR CZC63128X2
CZC63128X6 CZC6322Q82 CZC6322Q8B CZC6391G9V CZC6394DG0 CZC6394DG1 CZC64006JW
CZC64006JZ CZC64006KD CZC64006KX CZC64006KZ CZC64006L2 CZC642558V CZC642558W
CZC642559C CZC642559K CZC64255B0 CZC64255B3 CZC64255B5 CZC64255B7 CZC64255BF
CZC64255BH CZC64255BM CZC73312RG CZC73312RH CZC73312RL CZC73312S1 CZC7363P2W
CZC7363P34 CZC7363P38 CZC7363P3C CZC7363P3G CZC7363P3J CZC7363P3K CZC7364RT6
5089744 5100656 5126786 5129985 5156054 5165856 5165857 5171825 5175450 5175451
5175452 5182675 5182690 5199052 5199067 5199068 5213711 5213743 5222753 5225437
5225438 6004814 6048672 6049786 6049787 6061486 6061487 6061488 6061489 6061490
6061491 6061492 6095066 6161298 6279448 6315265 CZC5240Q1M CZC5280BS4 CZC5280BSF
CZC5280BSM CZC5280BST CZC5282454 CZC5391VDV CZC5441LL0 CZC5462BV6 CZC5492LJV
CZC5492LJZ CZC5510Y5W CZC5521M42 CZC5521M46 CZC5521M4P CZC5521M4Q 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 FRB4250QG5 FRB4250QGR FRB4250QGY FRB4250QH3 FRB4250SWV
FRB4250SWW FRB4250SZ9 FRB4250SZW FRB4250SZZ FRB4250T02 FRB4250T04 FRB4250T0M
FRB426011Q FRB4260129 FRB426013N FRB426013Z FRB4260140 CZC7364RTZ 5182721
5089743 5089745 5089746 5140815 5156050 5205320 5205322 6061496 6111274 6111275
6228473 6228586 CZC5240Q1C CZC5391VFY CZC5391VG6 CZC5492LKT CZC5492LL6
CZC62803TH CZC7364RS5 FRB426014P 5165859 5170762 5170766 5171811 5171812 5175448
5182684 5182693 5182699 5182705 5182707 5182708 5182722 5199041 5199042 5205301
5222765 6004796 6065625 6095050 CZC5240Q1D CZC5240Q1H 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 5132682 5148395 5148396 5148397 5165864 5165865 5165866
5165867 5171809 5182715 5182716 5182717 5199051 5205310 5205311 5225447
CZC5492LKB CZC5510Y5X CZC5521M4W CZC6181MTH CZC62803TN CZC6394D67 FRB4250SMJ
CZC5391VGG CZC642558M CZC6425592 5182713 5170760 CZC551046P CZC7105QDV
CZC7364RTW FRB4210XS1 FRB4250SZN CZC6425594 5165858 5225425 CZC5280BRW
CZC5460C87 CZC5492LKL CZC603076N CZC61030G6 CZC6322Q7F CZC6322Q7K CZC6322Q7S
CZC6394DGG CZC642558P CZC6425597 CZC642559B CZC7080QJ8 CZC7080QK7 FRB426012P
FRB426012T 5126774 5129986 5129987 5129988 5156272 5170746 5170747 5213726
5225424 5225430 5225435 CZC5240Q1F CZC5462BV3 CZC6181MT4 CZC6181MTN CZC6181MTQ
CZC7244NXM CZC7244NXQ CZC5472F88 CZC5472F8S 5213735 5225441 CZC53003BK
CZC6130L2H CZC6291WTN CZC63128WM CZC64511M0 CZC72414B3 CZC72414B6 CZC7250WNB
CZC7364RRG CZC7364RTK 5175454 5140807 5156083 5213707 5225426 5225436 CZC53003B2
CZC53003B5 CZC5492LK4 CZC63128X1 CZC642559F CZC64255B1 CZC7105QF1 CZC724149T
FRB4210XSD FRB4250SWZ FRB426011G FRB426013M 5182679 5089740 5123579 5123580
5123581 5156273 5156274 5156280 5182677 5199043 5199044 5199047 5199069 5199071
5199072 5225442 CZC5280BSS CZC53003B1 CZC5460C7B CZC5462BTZ CZC6130L3C
CZC64006L6 CZC642559Q CZC642559T CZC642559W CZC64255B6 CZC64255B9 CZC64255BD
CZC64255BL CZC64255BV CZC64255C7 CZC7080QJM CZC7105QDR CZC7132V7P CZC7414GGC
FRB4260120 FRB4260124 FRB4260125 FRB426013X 5100641 5115306 5156055 5156057
5165854 5170738 5170748 5170749 5171820 5171821 5171822 5171823 5175464 5175465
5182683 5205319 5205772 5205773 5205774 5205775 CZC5240Q13 CZC5240Q14 CZC5460C85
CZC5462HW5 CZC5492LL3 CZC61030G4 CZC61030GD CZC61030H2 CZC61544VD CZC61544VM
CZC61544VZ CZC6261MWH CZC6322Q7Q CZC64255BT CZC64255BY CZC7105QF2 CZC7105QF9
CZC7105QFD CZC7105QFJ CZC72126A6 CZC7212G4J 5100633 5100643 5140822 5148392
5156049 5170744 5213709 5213746 5213747 5213749 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 CZC6383VVK CZC6391G9W
CZC6391G9X CZC64006KN CZC64006KT CZC64006KV CZC64006L3 CZC72414B4 CZC7364RRY
CZC7244NXD CZC7244NXP 5065152 5065156 5065157 5065158 5065159 5077167 5077168
5148393 5156278 5156279 5156281 5175445 5175446 5175447 5175449 5199076 5199077
5199078 5199079 CZC5280BS5 CZC5280BSK CZC5460C7Y CZC5462HW0 CZC5462HW8
CZC5462HVY CZC5472F8T CZC5492LJS CZC5521M44 CZC6130L2J CZC6130L2L CZC6130L2T
CZC63128WF CZC63128WZ CZC63128X7 CZC63128X8 CZC63128XQ CZC64006JH CZC64255BC
CZC64255BJ CZC64255C2 CZC64255CD CZC6482WKG CZC7080QHY CZC7105QDY CZC7105QF8
CZC7105QFB CZC7105QFQ CZC7132V72 CZC7212G50 CZC721500K CZC7244NX4 CZC7244NX8
CZC7244NXC CZC7250WNP CZC7364RSH CZC7364RSS CZC7414GGL CZC7414GHT CZC5460C7K
CZC7105QFF 5065150 5065151 5065153 5065154 5065155 5077171 5077174 5126775
5126776 5126779 5140806 5140819 5140820 5140821 5156052 5156053 5156275 5156276
5156282 5156285 5165861 5170757 5175442 5182694 5182695 5182701 5182712 5182714
5199054 5199064 5199065 5213703 5225427 5225429 5225445 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 5205318 5213708 5213736 5213744
5213750 5225434 CZC6394DG3 CZC6482WK8 CZC6130L33 CZC7080QK5 CZC7244NX7 5126781
5126782 5126783 5126784 5140824 5148389 CZC6482WJS CZC6482WKF CZC6482WLG
CZC6482WLJ CZC7250WNN
RECALLING
FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Wauwatosa,
WI,
Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland. REASON
Failure to alarm: An active monitor could become disconnected from the unit
without any notification or alarm.
VOLUME OF PRODUCT IN COMMERCE
2,146 devices
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) 1
Liter Latex-Free Breathing Bags; Reservoir Bag; Vendor Part Number:
720059B, Medline Item Number: 40056; Available in various Anesthesia
Circuit Kits and Complete Delivery System kits including:
1) Item Number CDS980230I, NICU-OR CDS;
2) Item Number DYNJ22691, Basin Supply Pack;
3) Item Number DYNJ24724, Spine-Crani Anesthesia Kit;
4) Item Number DYNJAAHY11,
Hyperinflation System-UHS-1L;
5) Item Number DYNJAP0010, Anesthesia Circuit Ped-LF;
6) Item Number DYNJAP0011A, Pediatric Circuit-LF;
7) Item Number DYNJAP0012, Pediatric Anesthesia 40 In.
CI;
8) Item Number DYNJAP0100, Pedi Breathing Circuit-LF;
9) Item Number DYNJAP0101, Anesthesia Circuit-Ped;
10) Item Number DYNJAP4012, Anesthesia Circuit Ped;
11) Item Number DYNJAP4013, Anesthesia Circuit;
12) Item Number DYNJAP4702A, Anesth Circuit Ped GS Line;
13) Item Number DYNJAP4707, Anesth Circuit 40in Ped-LF;
14) Item Number DYNJAP4722, Anes Cir 40 Ped GSEPW HYBABYH;
15) Item Number DYNJAP4729A, Circ Ped Anes Super-LF;
16)
Item Number DYNJAP4730A, Circuit Pediatric Anesthesia;
17) Item Number DYNJAP4732, Anesth Circ Ped 40in 2B/V;
18) Item Number DYNJAP4740, Anesth Circ 40in Ped;
19)
Item Number DYNJAP6101, Anesthesia Circuit;
20) Item Number DYNJAP6105, Anesth Circuit 60in Ped;
21) Item Number DYNJAP6106, Anes Circ Ped 60in BI GSE-LF;
22) Item Number DYNJAP6107, Anesth Circ Ped 60in ANG HME;
23) Item Number DYNJAP6108, Anesth Circuit 60in Ped;
24) Item Number DYNJAP6109, Anesth Circ Ped 60in B/V
1L-LF;
25) Item Number DYNJAP6111, Anes Cir Ped 60 GSEPW
PALL FIL;
26) Item Number DYNJAP6112, Anesthesia-Peds
Circuit;
27) Item Number DYNJAP6113, Circuit Pedi 60in;
28) Item Number DYNJAP6114, Anesth Circ 60in Ped;
29) Item Number DYNJAP6116, Anesth Circ 60in Ped;
30) Item Number DYNJAP6120A, Pediatric Circuit 40in LF;
31) Item Number DYNJAP6124, Anesth Circ Pedi 60in 1L GSL;
32) Item Number DYNJAP6127, Anes Circ Pedi 60in-LF;
33) Item Number DYNJAP6130, Anesth Circ Ped 60in 1L-LF;
34) Item Number DYNJAP6132A, Circuit Pediatric Anesthesia;
35) Item Number DYNJAP6133, Anesth Circuit Peds 60in-LF;
36) Item Number DYNJAP6136, Circuit Peds Anesthesia;
37)
Item Number DYNJAP6137, Circuit Pediatric Anesthesia;
38)
Item Number DYNJAP7217A, Anesth Circuit 72in Exp Ped BI;
39) Item Number DYNJAP7225A, Circuit Pediatric Anesthesia;
40) Item Number DYNJAP7227, Anes. 90in Exp Pedi -LF;
41)
Item Number DYNJAP7233, Anes. Circuit 90in Exp Pedi-LF;
42) Item Number DYNJAP7234A, Anesthesia 72in Pediatric Exp;
43) Item Number DYNJAP7235A, Anesth Circ 72in Ped;
44)
Item Number DYNJAP7236A, Anesthesia Pedi 72in;
45) Item
Number DYNJAP7237, Circuit Pedi 90in EXP;
46) Item Number
DYNJAP7241A, Circuit Pediatric Anesthesia;
47) Item
Number DYNJAP7243B, Circ Anesth Ped 2 B/V LFree;
48) Item
Number DYNJAP7246C, Circuit Pediatric Anesthesia;
49)
Item Number DYNJAP7247, Anes Circ Peds 90in Exp;
50) Item
Number DYNJAP7248, Anesth Circ Ped 72in Exp;
51) Item
Number DYNJAP7261, Circuit Pediatric Anesthesia;
52) Item
Number DYNJAP7262, Circuit Pediatric Anesthesia;
53) Item
Number DYNJAP7263, Pediatric Anesthesia Circuits;
54)
Item Number DYNJAP9005, Anesthesia Circuit;
55) Item
Number DYNJAP9721A, Anesth Circuit Pedi HMEF LF;
56) Item
Number DYNJAP9725, Pedi Expand Circuit;
57) Item Number
DYNJAP9726, Anesth Circ Ped 90in;
58) Item Number
DYNJAP9729, Anesth Circ 90in Exp Ped;
59) Item Number
DYNJAP9730A, Circuit Pediatric 60in CORR-LF;
60) Item
Number DYNJAP9732A, Circuit Pediatric Anesthesia;
61)
Item Number DYNJAP9735, Peds Circuit;
62) Item Number
DYNJAP9739, Circuit Pediatric Anesthesia;
63) Item Number
DYNJAP9740, Circuit Pediatric Anesthesia;
64) Item Number
DYNJAP9743, Circuit Pediatric Anesthesia;
65) Item Number
DYNJAPF6003, Anesth Circ 60in Ped Unilimb;
66) Item
Number DYNJAPF6005A, Anesth Circ 60in Uni Peds;
67) Item
Number DYNJAPF6006, Anes Circ Peds 60in Uni;
68) Item
Number DYNJAPF6009, Peds Anesthesia Circuit-LF;
69) Item
Number DYNJAPF6011, Circuit Pediatric Anesthesia;
70)
Item Number DYNJAPF6013, Circuit Pediatric Anesthesia;
71) Item Number DYNJAPF6014, Pediatric Circuit;
72) Item
Number DYNJQ9160A, T&A Procedure,
Recall # Z-1162-2008;
b) 3 Liter
Latex-Free Breathing Bag; Reservoir Bag; Vendor Part Number: 720057B, Medline
Item Number: 40053; Available in various Anesthesia Circuit Kits and Complete
Delivery System Kits including:
1) Item Number DYNJ09422,
Anesthesia Kit-LF;
2) Item Number DYNJAA9010A, Anesthesia Circuit Adult
Expand;
3) Item Number 00-GS2675K, Pacemaker Kit;
4) Item Number ACC010004A, Anesthesia Drawer 6;
5) Item Number ACC010015, Anesthesia Drawer 8;
6) Item Number ACC010015A, Anesthesia Drawer 8;
7) Item Number ACC010031, Anesthesia Case Cart Drawer 6;
8) Item Number ACC010036, Anesthesia Drawer 6;
9) Item Number ACC010056, Anesthesia Cart Drawer 6;
10) Item Number CDS760048M, D&C CDS;
11) Item Number CDS760050L, Vag Hyster CDS;
12) Item Number CDS760054F, Laparoscopy CDS;
13) Item Number CDS780080J, Major Spinal CDS;
14) Item Number CDS780081G, Minor Spine CDS-LF;
15) Item Number CDS780127C, Lumbar CDS;
16) Item Number CDS780150A, Craniotomy CDS-LF;
17) Item Number CDS780151A,
Spinallami-Fusion-Disk-Lumb-LF;
18) Item Number
CDS840144B, Open Heart CDS;
19) Item Number CDS840270C,
Carotid CDS;
20) Item Number CDS840325B, Major Vascular
CDS;
21) Item Number CDS840336A, Heart-LF;
22) Item Number CDS840337A, Vascular Minor CDS-LF;
23) Item Number CDS840338A, Carotid Endarectomy CDS-LF;
24) Item Number CDS840384A, Open Heart CDS;
25) Item Number CDS840429, Arrowhead Open Heart CDS;
26) Item Number CDS840463A, Accessory Pack;
27) Item Number CDS840494, AV Fistula CDS;
28) Item Number CDS860094C, Laparoscopic Colon Resection;
29) Item Number CDS860109A, Laparoscop Bilat Tubal Lig-LF;
30) Item Number CDS860159, Major ABD Procedure CDS-Pack A;
31) Item Number CDS860159A, Major ABD Procedure CDS;
32)
Item Number CDS860160A, Minor ABD Procedure CDS;
33) Item
Number CDS860161, Lithotomy Major CDS;
34) Item Number
CDS860161A, Lithotomy Major CDS;
35) Item Number
CDS860200, Lap Appy Kit;
36) Item Number CDS860200A, Lap Appy Kit;
37) Item Number CDS860201, Lap Chole Kit;
38) Item Number CDS860201A, Lap Chole Kit;
39) Item Number CDS860202, Lap Nissen Kit;
40) Item Number CDS860202A, Lap Nissen Kit;
41) Item Number CDS920108C, Laparoscopy CDS;
42) Item Number CDS930145C, Lap Chole CDS;
43) Item Number CDS930178F, Lap Chole Somc CDS-LF;
44) Item Number CDS930183A, Lap Chole CDS-LF;
45) Item Number CDS930208B, Lap Chole CDS;
46) Item Number CDS940836B, Shoulder CDS;
47) Item Number CDS940836C, Shoulder CDS;
48) Item Number CDS940837B, Knee CDS;
49) Item Number CDS940844C, Shoulder Arthroscopy CDS;
50) Item Number CDS940859C, Arthroscopy CDS-LF;
51) Item Number CDS940896F, Arthroscopy CDS;
52) Item Number CDS940900F, Shoulder CDS;
53) Item Number CDS941067A, Knee Replacement Total-LF;
54) Item Number CDS941068B, Total Hip CDS-LF;
55) Item Number CDS941248, Extremity Ortho CDS;
56) Item Number CDS941248A, Extremity Ortho CDS;
57) Item Number CDS941325, Dr Zeegan Total Hip Encino;
58) Item Number CDS941326, Dr Zeegan Total Hip Encino;
59) Item Number CDS980153B, Basic CDS;
60) Item Number CDS980211C, O.R. Turnover Kit;
61) Item Number CDS980228K, Breast Biopsy CDS;
62) Item Number CDS980232L, Plastic CDS;
63) Item Number CDS980395, D&C/Vaginal Minor CDS-LF;
64) Item Number CDS980510D, Neuro Associates Laminectomy;
65) Item Number CDS980701, Shoulder Arthroscopy
Procedure;
66) Item Number CDS980702, Knee Arthroscopy
Procedure;
67) Item Number CDS980703, Extremity
Procedure;
68) Item Number CDS980704, Spine Procedure;
69) Item Number CDS980749, Minor CDS;
70) Item Number CDS980794, Lithotomy CDS;
71) Item Number CDS980796, Knee Arthroscopy CDS;
72) Item Number CDS980797, Gyn Abd CDS;
73) Item Number CDS980798, C-Section CDS;
74) Item Number CDS980799, Lap Chole CDS;
75) Item Number CDS980800, Hand CDS-Dr Casey;
76) Item Number CDS980801A, Lap Gastric CDS;
77) Item Number CDS980817, Total Hip CDS;
78) Item Number CDS980818, AV Fistula CDS;
79) Item Number CDS980819, Knee Arthroscopy CDS;
80) Item Number CDS980820, Shoulder Arthroscopy CDS;
81) Item Number CDS980821, Spine CDS;
82) Item Number CDS980822, Total Knee CDS;
83) Item Number CDS980823, Hand CDS;
84) Item Number CDS980831, Gastric Bypass CDS;
85) Item Number CDS980846, Spinal CDS-LF;
86) Item Number CDS980847, Laparoscopy CDS-LF;
87) Item Number CDS980848, Universal Drape CDS;
88) Item Number CDS980849, Vascular Split Drape CDS;
89) Item Number CDS980850, Laminectomy CDS;
90) Item Number CDS980851, Head and Neck CDS;
91) Item Number CDS980904, Minor Procedure CDS;
92) Item Number CMPJ21747A, Extremity Pack;
93) Item Number CMPJY0146D, Peripheral Vascular-LF;
94) Item Number DYNJAA0063, Anesthesia Super Circuit;
95) Item Number DYNJAA0261B, Anesthesia Super Circuit-LF;
96) Item Number DYNJAA0266A, Anesth Super Circ 60in Uni;
97) Item Number DYNJAA0283B, Anesth Circ 40in Adult
3LTR-LF;
98) Item Number DYNJAA4751, Custom
Circuit-Adult;
99) Item Number DYNJAA4755A, Anesthesia
Circuit;
100) Item Number DYNJAA4757A, Anesth Circ 40in
Adult Discnct;
101) Item Number DYNJAA4761, Anesth Circ
40in Adult;
102) Item Number DYNJAA4765C, Kit Anesthesia
Accessory;
103) Item Number DYNJAA4774, Anesth Circ 40in
Adult;
104) Item Number DYNJAA4776A, Circuit Adult
Anesthesia;
105) Item Number DYNJAA4778, Anesth Circ
Adult 40in 2BV SWI;
106) Item Number DYNJAA4791A, Circuit
Adult Anesthesia;
107) Item Number DYNJAA4792, Circuit
Anes Adult 40in Corr;
108) Item Number DYNJAA4798, Anes
Circ 40 Ltx Free Gas Lin;
109) Item Number DYNJAA4805,
Circuit Adult Anesthesia;
110) Item Number DYNJAA4808,
Adult Anesthesia Circuit;
111) Item Number DYNJAA4808A,
Adult Anesthesia Circuit;
112) Item Number DYNJAA4809,
Circuit Adult Anesthesia-LF;
113) Item Number
DYNJAA4809A, Circuit Adult Anesthesia-LF;
114) Item
Number DYNJAA4811A, Circuit Adult Anesthesia;
115) Item
Number DYNJAA4812, Adult Anesthesia Circuit;
116) Item
Number DYNJAA4815, Adult Anesthesia Circuit;
117) Item
Number DYNJAA4816, Circuit Adult Anesthesia;
118) Item
Number DYNJAA4817, Circuit Adult Anesthesia;
119) Item
Number DYNJAA4819, Anesthesia Circuit Adult Kit;
120) Item
Number DYNJAA4820, Circuit Adult Anesthesia;
121) Item
Number DYNJAA4821, Adult Anesthesia Circuit;
122) Item
Number DYNJAA4828, Circuit Adult Anesthesia;
123) Item
Number DYNJAA6420B, AVH Breathing Circuit-LF;
124) Item
Number DYNJAA6445, Anesthesia Circuit 60 LFree;
125) Item
Number DYNJAA6453, Anesth Circ Adult 60in;
126) Item
Number DYNJAA6459A, Anesthesia Circuit;
127) Item Number
DYNJAA6461B, Anes Circ Adult 90in EXP-LF;
128) Item
Number DYNJAA6474, Circuit Adult Anesthesia;
129) Item
Number DYNJAA6475, Circuit Adult Anesthesia;
130) Item
Number DYNJAA6483, Circuit Adult Anesthesia;
131) Item
Number DYNJAA6485A, Adult Anesthesia Circuit;
132) Item
Number DYNJAA6486, Circuit Adult Anesthesia;
133) Item
Number DYNJAA6489, Circuit Adult Anesthesia;
134) Item
Number DYNJAA6490, Adult Anesthesia Circuit;
135) Item
Number DYNJAA9010A, Anesthesia Circuit Adult Exp;
136)
Item Number DYNJAA9040, Anesthesia Circuit;
137) Item
Number DYNJAA9700B, Circuit Adult Anesthesia;
138) Item
Number DYNJAA9714C, Nurses Kit-LF;
139) Item Number
DYNJAA9717, Anesth Circuit 90 Inch HME-LF;
140) Item
Number DYNJAA9724A, Anesthesia Circuit Adult;
141) Item
Number DYNJAA9726, Anesthesia Circuit;
142) Item Number
DYNJAA9729A, Anesth Circuit 60 HME;
143) Item Number
DYNJAA9748, Anesthesia Circuit-LF;
144) Item Number
DYNJAA9762, Anesth Circuit 90in EXP Adult;
145) Item
Number DYNJAA9774A, Anesth Circuit Expan Swiv;
146) Item
Number DYNJAA9777C, Circuit Adult Anesthesia;
147) Item
Number DYNJAA9779, Anesth Circ 90in EXP Adult;
148) Item
Number DYNJAA9783, Adult Anesthesia;
149) Item Number
DYNJAA9814, Adult Expandable Circuit;
150) Item Number
DYNJAA9819, Anesth Circuit 90in EXP-LF;
151) Item Number
DYNJAA9821, Anesth Circ Adult 90in EXP;
152) Item Number
DYNJAA9833, Anesth Circ 120in EXP Adult;
153) Item Number
DYNJAA9834, Adult Circuit 90in Expandable;
154) Item
Number DYNJAA9835B, Circuit Adult Anesthesia;
155) Item
Number DYNJAA9836, Anesth Circ 90inch EXP Adult;
156)
Item Number DYNJAA9837, Anesth Circ 90in EXP Adult;
157)
Item Number DYNJAA9840, Circuit Adlt 90in Expand;
158)
Item Number DYNJAA9842, Anesth Circ 90in EXP Adult-LF;
159) Item Number DYNJAA9844B, Circ Anesth 90in GSP 2 B/V-LF;
160) Item Number DYNJAA9845, Anesth Circuit 90in Swivel;
161) Item Number DYNJAA9864A, Circuit Adult Anesthesia;
162) Item Number DYNJAA9865, Anesthesia Circuit;
163) Item Number DYNJAA9871, Circuit Adult 90in EXP-LF;
164) Item Number DYNJAA9874, Anesthesia Circuit;
165) Item Number DYNJAA9879, Circuit Anes Adult 90in
EXP-LF;
166) Item Number DYNJAA9880, Circuit Adult Anes
90in EXP;
167) Item Number DYNJAA9884, Circuit Adult 90in
EXP-LF;
168) Item Number DYNJAA9888, Adult Anesthesia
Circuit-LF;
169) Item Number DYNJAA9889B, Anesthesia
Circuit Adult;
170) Item Number DYNJAA9890, Circuit Adult
Anesthesia;
171) Item Number DYNJAA9894, Circuit Adult
Anesthesia;
172) Item Number DYNJAA9898, Circuit Adult
Anesthesia;
173) Item Number DYNJAA9899, Circuit Adult
Anesthesia;
174) Item Number DYNJAA9900, Circuit Adult
Anesthesia;
175) Item Number DYNJAA9900B, Circuit Adult
Anesthesia;
176) Item Number DYNJAA9902, Circuit Adult
Anesthesia;
177) Item Number DYNJAA9903, Circuit Adult
Anes-SM-MRMC-RC;
178) Item Number DYNJAA9905, Circuit
Adult Anesthesia;
179) Item Number DYNJAA9907, Circuit
Adult Anesthesia;
180) Item Number DYNJAA9915, Circuit
Adult Anesthesia;
181) Item Number DYNJAA9918, Adult
Anesthesia Circuit-LF;
182) Item Number DYNJAA9919,
Circuit Adult Anesthesia;
183) Item Number DYNJAA9920,
Circuit Adult Anesthesia;
184) Item Number DYNJAA9921,
Circuit Adult Anesthesia;
185) Item Number DYNJAA9924,
Adult Anesthesia Circuit;
186) Item Number DYNJAA9925,
Anesthesia Circuits;
187) Item Number DYNJAA9927,
Anesthesia Super Circuit Kit;
188) Item Number
DYNJAA9928, Adult Anesthesia Circuit;
189) Item Number
DYNJAA9930, Adult Anesthesia Circuit;
190) Item Number
DYNJAA9931, Anesthesia Circuit;
191) Item Number
DYNJAAF6258A, Anesthesia Circuit;
192) Item Number
DYNJAAF6262, Anesthesia Circuit Valley Hlth;
193) Item
Number DYNJAAF6288A, Circuit Adult Uni 50in-LF;
194) Item
Number DYNJAAF6293, Anesth Circ 72in Unilimb Adult;
195)
Item Number DYNJAAF6295, Anesth Circ Adult Uni;
196) Item
Number DYNJAAF6297A, Adult Anes Circuit-LF;
197) Item
Number DYNJAAF6298A, Adult Anes Circuit-LF;
198) Item
Number DYNJAAF6302, Adult Anesthesia Circuit;
199) Item
Number DYNJAAF6324, Adult Anesthesia Circuit;
200) Item
Number DYNJAAF6326, Circuit Adult Anesthesia;
201) Item
Number DYNJAAF6327, Adult Anesthesia Circuit;
202) Item
Number DYNJAAF6329, Circuit Adult Anesthesia;
203) Item
Number DYNJAAF6330, Anesthesia Circuit Adult;
204) Item
Number DYNJAAF6331, Adult Anesthesia Circuit;
205) Item
Number DYNJAAF6341, Adult Anesthesia Circuit;
206) Item
Number DYNJAAF6342, Circuit Adult Anesthesia;
207) Item
Number DYNJAAF6343, Circuit Adult Anesthesia;
208) Item
Number DYNJAAF6344, Circuit Adult Anesthesia;
209) Item
Number DYNJAAF6345, Adult Anesthesia Circuit;
210) Item
Number DYNJAAF6346, Anesth Circuit 72in Uni Adult;
211)
Item Number DYNJAAHY13, Circuit Anes Mapleson D-LF;
212)
Item Number DYNJAAHY14, Circuit Adult Uni 192in GSE;
213)
Item Number DYNJT2590, Lap General CDS;
214) Item Number
DYNJT2591A, Knee ACL CDS,
Recall # Z-1163-2008;
c) 2 Liter Latex-Free
Breathing Bag; Reservoir Bag; Vendor Part Number: 720058B, Medline Item Number:
40054; Available in various Anesthesia Circuit Kits and Complete Delivery System
Kits including:
1) Item Number CDS980652A, Thoracic
Anesthesia Pack;
2) Item Number CDS980955, Affinity
Shoulder Arthroscopy;
3) Item Number CDS980956, Affinity
Total Hip CDS;
4) Item Number CDS980957, Affinity Total
Knee CDS;
5) Item Number DYNJAA4758B, Circuit Adult Anesthesia;
6) Item Number DYNJAA4777, Adult 40in Anesth w/HME-LF;
7) Item Number DYNJAA9796, Anes Circuit 90in EXP
Adult-LF;
8) Item Number DYNJAA9847A, Adult Circuit;
9) Item Number DYNJAA9904, Circuit Adult Anesthesia;
10) Item Number DYNJAA9904A, Circuit Adult Anesthesia;
11) Item Number DYNJAA9906, Circuit Adult Anesthesia;
12) Item Number DYNJAA9933, Anesthesia Super Circuit;
13) Item Number DYNJAAF6318A, Adult Anesthesia Circuit;
14) Item Number DYNJAP4726, Pedi Circuit 40in;
15) Item Number DYNJAP4737A, Circuit Pediatric
Anesthesia;
16) Item Number DYNJAP4737B, Circuit
Pediatric Anesthesia;
17) Item Number DYNJAP4737C,
Circuit Pediatric Anesthesia;
18) Item Number DYNJAP4744,
Pediatric Anesthesia Circuit;
19) Item Number DYNJAP6138,
Circuit Pediatric Anesthesia;
20) Item Number DYNJAP7258,
Circuit Pediatric Anesthesia;
21) Item Number DYNJAP7259,
Peds Anesthesia Circuit;
22) Item Number DYNJAPF6007,
Circuit Ped Uni 60in-LF;
23) Item Number DYNJAPF6012,
CODE
a) All lots manufactured after October 2006:
1) Lot Numbers: 07JB0905;
2) Lot Number: 07HD1853;
3) Lot
Number: 07KB5026;
4) Lot Number: 07HD3686;
5) Lot Number: 07KD3028;
6)
Lot Numbers: 07HD4225, 07JD4412 and 07KD0167;
7) Lot
Numbers: 07JD3974 and 07KD2230;
8) Lot Numbers: 07ID1739,
07ID3570 and 07JD2943;
9) Lot Number: 07ID2242;
10) Lot Numbers: 07ID1545, 07JD2944 and 07JD3987;
11) Lot Number: 07ID1524;
12) Lot
Number: 07HD3333;
13) Lot Numbers: 06LD3453, 07HD2988 and
07JD3927;
14) Lot Number: 07ID2432;
15)
Lot Numbers: 07ID4021 and 07JD4476;
16) Lot Number:
07HD3649;
17) Lot Numbers: 07ED4394 and 07KB1986;
18) Lot Numbers: 07ID0168, 07ID2021, 07ID4063, 07JD1340
and 07JD4573;
19) Lot Number: 07JD1161;
20) Lot Numbers: 07ID0137 and 07KD2092;
21) Lot Number: 07KD0278;
22) Lot
Number: 07JD0779;
23) Lot Numbers: 07ID0135 and
07JD0018;
24) Lot Numbers: 07HD4400, 07JD0205 and
07KD2228;
25) Lot Numbers: 07ID1373 and 07KB4359;
26) Lot Number: 07ID1546;
27) Lot
Number: 07HD4394;
28) Lot Numbers: 07HD3332 and 07KD0567;
29) Lot Number: 07ID2441;
30) Lot
Number: 07ID1521;
31) Lot Numbers: 07HD3288, 07JD0019 and
07KD0358;
32) Lot Number: 07ID2266;
33) Lot Numbers: 07HD3650 and 07KD0363;
34) Lot Number: 07JD0020;
35) Lot
Number: 07JD0206;
36) Lot Number: 07KD1036;
37) Lot Number: 07GD2133;
38) Lot
Numbers: 07CD3854 and 07DD3017;
39) Item Number:
DYNJAP7225A, Lot Numbers: 07GD1534 and 07HD3562;
40) Lot
Number: 07JD1538;
41) Lot Numbers: 07CD0839 and 07ED0027;
42) Lot Numbers: 07HD3459 and 07ID2630;
43) Lot Number: 07ID2244;
44) Lot Numbers: 07HD1578 and 07ID0169;
45) Lot
Numbers: 06KD0647, 06LD3890, 07BD0978, 07BD3099, 07CD3597, 07DD3536,
07GD3218, 07HD3876, 07JD1158 and 07JD3969;
46) Lot
Number: 07HD3110;
47) Lot Numbers: 07DD3540, 07ED4104,
07GD1839 and 07JD1190;
48) Lot Numbers: 07IB2772 and
07JD0023;
49) Lot Number: 07JD1541;
50) Lot
Number: 07KD1275;
51) Lot Numbers: 07HD2917, 07ID3527 and
07JD2945;
52) Lot Number: 07HD3564;
53) Lot Number: 07ID0954;
54) Lot Number: 07HD1253;
55) Lot Numbers: 07ID2017 and 07KD2298;
56) Lot Number: 07JB3948;
57) Lot
Number: 07HD2409;
58) Lot Number: 07JD2946;
59) Lot Number: 07ID1106;
60) Lot
Numbers: 07CD1687, 07ED0308, 07GD2552, 07HD2648, 07JD0024 and
07KD2223;
61) Lot Number: 07DD4279;
62) Lot
Numbers: 07DD0014 and 07DD3537;
63) Lot Number: 07DD1134;
64) Lot Numbers: 07ID0387, 07ID1751, 07JD1148, 07KD0651
and 07KD1360;
65) Lot Numbers: 07CD1292, 07DD2344,
07ED0732, 07GD3088 and 07HD1080;
66) Lot Number:
07ID1348;
67) Lot Numbers: 07HD2210 and 07ID2019;
68) Lot Numbers: 07ID2076 and 07JD3978;
69) Lot Number: 07HD4155;
70) Lot
Numbers: 07ED3128, 07GD1327 and 07ID1374;
71) Lot Number:
07ID0924;
72) Lot Numbers: 07BB1382, 07CB0600 and
07CB2528;
b) All lots manufactured after October 2006:
1) Lot Number(s): 07AD2431, 07ED1171, 07FD0986 and
07GD2699;
2) Lot Number(s): 06KD0470, 06LD3329, 07AD3822,
07AD4358 and 07HD3295;
3) Lot Number(s): 07ID2989;
4) Lot
Number(s): 07HD1850;
5) Lot Number(s): 07ED3319 and
07GD1409;
6) Lot Number(s): 07ID2781;
7) Lot Number(s): 07ID3356;
8) Lot
Number(s): 07GD3908;
9) Lot Number(s): 07JD0955;
10) Lot Number(s): 07IB2033;
11)
Lot Number(s): 07HB0383;
12) Lot Number(s): 07HD0309;
13) Lot Number(s): 07ID3376;
14)
Lot Number(s): 07HD2880;
15) Lot Number: 07AD4385,
07DD3000, 07EB2335 and 07FB0786;
16) Lot Number(s):
07BD1234, 07ED3375, 07FB2636, 07HB0382,
7HB1155 and 07HB2927;
17) Lot Number(s): 07BD4019, 07CD2926, 07FD1473, 07GB1293
and 07IB3415;
18) Lot Number(s): 07CD2326;
19) Lot Number(s): 07CD2354;
20)
Lot Number(s): 07BD1712;
21) Lot Number(s): 07AD3267,
07GD3398, 07HB0377, 07HB1614 and 07IB2544;
22) Lot
Number(s): 07AD4393, 07EB1526 and 07HB2822;
23) Lot
Number(s): 07BD1721, 07EB1377, 07EB2694 and 07JB0441;
24)
Lot Number(s): 07BB2640, 07EB1713, 07HB3147 and 07IB0469;
25) Lot Number(s): 07FB2624, 07GB3695 and 07IB2392;
26)
Lot Number(s): 07JD1168;
27) Lot Number(s): 07JD1170;
28) Lot Number(s): 07HD2053;
29)
Lot Number(s): 07GB0028, 07HB1342, 07HB2825 and 07IB1735;
30) Lot Number(s): 07BD0203 and 07CD3891
31) Lot Number(s):
07EB0667, 07FB2140, 07GB2805 and 07HB2823;
32) Lot
Number(s): 07GB1298;
33) Lot Number(s): 07AD2448,
07BD2109 and 07CD3361;
34) Lot Number(s): 07EB0665,
07FB2520 and 07IB2854;
35) Lot Number(s): 07CB0292 and
07GB1777;
36) Lot Number: 07HB3748;
37) Lot Number(s): 07CB0971, 07GB0032 and 07HB3327;
38) Lot Number(s): 07IB2695 and 07IB3323
39) Lot Number: 07CB0724;
40) Lot
Number: 07IB2397;
41) Lot Number: 07IB2040;
42) Lot Number(s): 07BD0419 and 07BD1236;
43) Lot Number: 07HD3194;
44) Lot
Number(s): 07ED2055, 07FB2141, 07GB1198, 07HB0185 and
07IB0688;
45) Lot Number(s): 07HD2395, 07HD2894, 07ID0410, 07ID1525
and
07ID3717;
46) Lot Number(s): 07BB0310, 07BB2177, 07DB1981 and
07FB0922;
47) Lot Number(s): 07HB2928;
48) Lot Number(s): 07BB0816, 07CB1831, 07EB2017,
07GB2618, 07IB2042
and 07JB1297;
49) Lot Number: 07HD0758;
50) Lot Number: 07ID1408;
51) Lot
Number(s): 07HB2923 and 07IB2386
52) Lot Number(s):
07HB2830 and 07JB0623
53) Lot Number(s): 07AD3293,
07GB3699 and 07IB3416;
54) Lot Number(s): 07BD4018,
07CD2932, 07EB2149, 07FB2398 and
07HB0187;
55) Lot Number: 07BD0238;
56) Lot
Number(s): 07FB0011, 07GB0862 and 07HB2926;
57) Lot
Number(s): 07AB2984, 07DB1789 and 07EB0575;
58) Lot
Number(s): 07AB3152 and 07DB1429;
59) Lot Number(s):
07GD2828 and 07ID3811;
60) Lot Number(s): 07BB2436,
07EB0679, 07FB0908, 07GB2130, 07IB0877
and 07IB2043;
61) Lot Number: 07JB0431;
62) Lot
Number: 07JB0875;
63) Lot Number(s): 07FB0342, 07GB0023
and 07HB2936;
64) Lot Number: 07JG0038;
65) Lot Number(s): 07GB1780 and 07HB1153;
66) Lot Number: 07GB1908;
67) Lot
Number(s): 07FB2626, 07HB2824 and 07HB3284;
68) Lot
Number(s): 07GB2450 and 07JB1024
69) Lot Number(s):
07JD0762 and 07JD1353;
70) Lot Number: 07GG1799;
71) Lot Number: 07HG0901;
72) Lot
Number: 07HG0336;
73) Lot Number: 07HG0424;
74) Lot Number(s): 07HG0426 and 07HG0678;
75) Lot Number: 07HB3544;
76) Lot
Number: 07HB2940;
77) Lot Number: 07ID3858;
78) Lot Number: 07ID2696;
79) Lot
Number: 07ID2697;
80) Lot Number: 07ID2698;
81) Lot Number(s): 07ID2699;
82)
Lot Number: 07ID3857;
83) Lot Number: 07ID2700;
84) Lot Number: 07HB3758;
85) Lot
Number(s): 07IB2156 and 07IB3031;
86) Lot Number:
07IB2155 and 07JB1326;
87) Lot Number: 07ID2895;
88) Lot Number: 07ID2892;
89) Lot
Number: 07ID2893;
90) Lot Number: 07ID2894;
91) Lot Number: 7JD1193;
92) Lot
Number: 07CD3683;
93) Lot Number: 07JD0233;
94) Lot Number(s): 07BD1218, 07FD2268 and 07GD3483;
95) Lot Number: 07HD3458;
96) Lot Number(s): 07BD0007,
07CD3097, 07FD0995, 07GD3474 and 07JD0008;
97) Lot
Number(s): 07DD2175, 07GD2614, 07ID2910 and 07JB0510;
98)
Lot Number: 07FD1245;
99) Lot Number: 06JD1180;
100) Lot
Number(s): 06JD3969, 06LD0329, 07AD3249, 07CD2866, 07FD1850,
07GD3141
and 07ID3529;
101) Lot Number(s): 07ED3321, 07HD2674 and
07JB0815;
102) Lot Number: 07HD3543;
103) Lot Number(s): 07IB3301, 07AD3250, 07FD1249 and
07GD3473;
104) Lot Number: 07ID0143;
105) Lot Number(s): 07JB0818, 07DD1385, 07GD1823 and
07ID2682;
106) Lot Number(s): 06KD1613, 07AD1653,
07FD1363, 07HD0086 and
07JD0392;
107) Lot Number(s): 07JB0819, 07ED3324 and 07GD2939;
108) Lot Number(s): 07JB1563, 07FD0991, 07FD2266 and
07ID2691;
109) Lot Number(s): 07CD4296, 07FD1247 and
07GD3573;
110) Lot Number(s): 07DD2013 and 07DD2013Z;
111) Lot Number(s): 07JB0475 and 07GD3595;
112) Lot Number(s): 07CD3606, 07DD3012, 07ED3339 and
07GD1601;
113) Lot Number(s): 07HD2208 and 07JD1189;
114) Lot Number: 07HD3460;
115) Lot
Number(s): 07FD1852, 07HD4223 and 07JD0947;
116) Lot
Number(s): 07GD1570 and 07ID0400;
117) Lot Number(s):
07JB1109 and 07HD2035;
118) Lot Number: 07HD2542;
119) Lot Number: 07ID3545;
120)
Lot Number: 07ID3132;
121) Lot Number: 07ID3133;
122) Lot Number: 07ID3566;
123)
Lot Number(s): 07BD1213, 07CD3099, 07FD1853 and 07ID2690;
124) Lot Number(s): 06KD1164, 07AD2804, 07ED3419, 07FD2065, 07GD1811
and
07ID3544;
125) Lot Number(s): 06JD3029, 07BD3638,
07CD3860, 07FD0992, 07HD0227
and
07JD0013;
126) Lot Number(s): 07GD1321 and 07ID2684;
127) Lot Number(s): 07BD0562, 07CD4301, 07FD2267,
07GD1509, 07HD2211
and
07JB1650;
128) Lot Number(s): 06JD3397, 07BD3634,
07GD1830, 07HD2654, 07HD4142
and
07ID0705;
129) Lot Number(s): 06JD0389, 06LD2328,
07AD3246, 07CD1502Z, 07DD0723,
07ED3328, 07FD1856, 07HD3287 and 07JD0745;
130) Lot
Number(s): 07FD1846, 07GD1843, 07HD2647 and 07ID2666;
131) Lot Number(s): 07GD3936, 07HD2036 and 07ID4039;
132)
Lot Number: 07HD0572;
133) Lot Number: 07ID3824;
134) Lot Number: 07JD0595;
135)
Lot Number(s): 06KD0470, 06LD3329, 07AD3822, 07AD4358 and
07HD3295;
136) Lot Number(s): 07AD3240, 07CD3101 and 07DD2177;
137) Lot Number(s): 07DD1140, 07GD2265, 07HD0692 and
07ID3879;
138) Lot Number(s): 07ED3325, 07GD1511 and
07HD3481;
139) Lot Number(s): 07ED3329, 07GD2196 and
07ID2683;
140) Lot Number(s): 07JB0816, 07BD0292,
07FD1412 and 07HD4093;
141) Lot Number(s): 07AD4482,
07CD2681, 07ED3543, 07FD0971,
07HD2212
and 07ID3883;
142) Lot Number(s): 07ED3330, 07HD2213 and
07ID2688;
143) Lot Number(s): 07DD0241, 07DD0241Z,
07FD1625 and 07GD1837;
144) Lot Number(s): 07JB0478,
07ED3331 and 07HD3334;
145) Lot Number(s): 07AD4951,
07FD1409, 07GD2198 and 07HD4257;
146) Lot Number(s):
07GD3594, 07HD0690, 07ID3119 and 07JD0230;
147) Lot
Number(s): 07BD0195, 07BD2655, 07ED3332, 07GD1507 and 07HD4255;
148) Lot Number(s): 07DD2803 and 07ID3880;
149) Lot Number(s): 06KD1949, 07AD4956, 07CD4293,
07FD1627, 07HD2037
and 07ID3124;
150) Lot Number(s): 07BD2651,
07DD2181, 07HD2048 and 07IB2728;
151) Lot Number:
06JD4351;
152) Lot Number(s): 07BD3652, 07DD0227,
07FD1248, 07HD3316 and 07ID3878;
153) Lot Number(s):
07DD0228, 07DD0228Z, 07GD1542 and 07HD3315;
154) Lot
Number(s): 07AD4084, 07ED3322, 07FD1858 and 07ID2692;
155) Lot Number(s): 07AD3251, 07AD4952, 07ED3320, 07FD2072,
07HD2049
and 07ID2909;
156) Lot Number(s): 07DD0726, 07FD0993,
07GD3476 and 07JD0203;
157) Lot Number(s): 07DD0239,
07DD0239Z, 07GD1869 and 07ID3382;
158) Lot Number(s):
07BD3943, 07CD3102 and 07HD2047;
159) Lot Number(s):
07AD3253, 07BD3123, 07CD3103, 07FD0987, 07GD1600,
07HD2050,
07HD2922, 07ID2934 and 07JD0781;
160) Lot Number(s):
07CD3623, 07GD2195 and 07JD0015;
161) Lot Number(s):
07BD2911, 07DD0495, 07GD2283, 07ID2908 and 07JB0842;
162)
Lot Number(s): 07BD3257, 07ED3326, 07GD2670 and 07JD1188;
163) Lot Number(s): 07BD0553, 07BD2637, 07CD3863 and 07HD0081;
164) Lot Number(s): 07DD0694, 07GD1508 and 07ID3882;
165) Lot Number(s): 07JB0820, 07GD1308 and 07HD2408;
166) Lot Number(s): 07BD0559, 07FD1845, 07GD3938 and
07ID3117;
167) Lot Number(s): 07JB0503, 07BD3945,
07CD4294, 07FD0972, 07GD2668
and
07ID2687;
168) Lot Number(s): 07BD2490, 07DD0684,
07FD1243, 07GD2930 and 07JD0942;
169) Lot Number:
07ID0134;
170) Lot Number: 07BD0189, 07CD2682, 07FD1859
and 07HD4256;
171) Lot Number: 07BD2306;
172) Lot Number(s): 07FD0970, 07GD1510, 07GD3937 and
07ID2686;
173) Lot Number(s): 07BD2907, 07FD1860,
07HD0578 and 07ID3565;
174) Lot Number: 07FD1246;
175) Lot Number: 07IB3073;
176)
Lot Number(s): 07DD2343, 07FD0973, 07GD1490, 07HD0577,
07ID3094
and 07JD0946;
177) Lot Number(s): 07CD3620, 07GD1506 and
07ID3125;
178) Lot Number(s): 07ED3323, 07GD3571 and
07JD0778;
179) Lot Number: 07GD1370;
180) Lot Number: 07FD1861;
181)
Lot Number: 07GD2288;
182) Lot Number(s): 07GD1599 and
07ID0405;
183) Lot Number(s): 07GD1598 and 07ID3531;
184) Lot Number(s): 07HD1779 and 07JD0958;
185) Lot Number: 07HD1793;
186)
Lot Number: 07HD2215;
187) Lot Number: 07ID2681;
188) Lot Number: 07ID0371;
189)
Lot Number: 07ID2680;
190) Lot Number: 07JD0364;
191) Lot Number(s): 07BD2652, 07DD0242, 07FD0994,
07GD2201 and 07ID2689;
192) Lot Number(s): 07BD1511,
07DD0240, 07ED3544, 07FD1410, 07GD2938,
07HD3304
and 07ID3538;
193) Lot Number(s): 06JD2484, 06LD2319,
07DD0709, 07GD1498 and 07HD3552;
194) Lot Number(s):
07IB2810, 07BD2650, 07ED3327, 07GD1543 and 07HD3871;
195)
Lot Number: 07BD2915;
196) Lot Number(s): 06KD0463,
06LD3452, 07AD4085, 07FD1406 and 07GD3142;
197) Lot
Number(s): 07IB3086, 06JD3221, 06LD0318, 07CD4297, 07GD2194,
07HD3480
and 07ID3741;
198) Lot Number(s): 07FD1844, 07GD3572 and
07ID2685;
199) Lot Number(s): 07BD3422, 07CD3540,
07FD2069 and 07HD4247;
200) Lot Number(s): 07CD2879,
07CD3617, 07FD0974, 07FD1848, 07GD3260,
07HD0922,
07ID3091 and 07JD0933;
201) Lot Number: 07ID3089;
202) Lot Number(s): 07DD1133, 07ED3333 and 07GD3794;
203) Lot Number(s): 07DD1125, 07GD1863 and 07ID1104;
204) Lot Number(s): 07FD1244 and 07HD4285;
205) Lot Number(s): 07HD2038 and 07ID3093;
206) Lot Number(s): 07GD1337 and 07GD2157;
207) Lot Number(s): 07HD0226 and 07ID3807;
208) Lot Number(s): 07HD3162; 209) Lot Number: 07ID0138;
210) Lot Number: 07JD0231;
211)
Lot Number(s): 06JD2830, 07AD1669, 07CD2886, 07FD1420, 07HD0675
and
07ID1346;
212) Lot Number: 06KD3560;
213) Lot Number: 07JB0017;
214)
Lot Number: 07JB0632
c) All lots manufactured after October 2006:
1) Lot Number: 07JD0594;
2) Lot
Number: 07KD0352;
3) Lot Number: 07KD0281;
4) Lot Number: 07KD0282;
5) Lot
Number(s): 07DD2346, 07ID2931 and 07KB2367;
6) Lot
Number(s): 07DD2800, 07DD4133, 07ID3130, 07JB1784, 07KB3600;
7) Lot Number(s): 07DD1377, 07DD2347, 07GD1504, 07ID3383,
07JB2589;
8) Lot Number(s): 07FD0840, 07FD3218, 07ID2679
and 07KB1977;
9) Lot Number(s): 07ED1416, 07ED3547 and
07FD1256;
10) Lot Number: 07JB2027;
11) Lot
Number(s): 07DD2538 and 07FD0568;
12) Lot Number(s): 07JD1295
and 07KD2315;
13) Lot Number(s): 07ID3358, 07JD0005 and
07KD3034;
14) Lot Number(s): 07DD1381 and 07KD1419;
15) Lot Number: 07AD0945;
16) Lot Number:
07DD2005;
17) Lot Number(s): 07ID3877 and 07KD2238;
18) Lot Number: 07GD1491;
19) Lot Number:
07ID3357;
20) Lot Number: 07KB4822;
21) Lot
Number(s): 07GD1121 and 07JD0740; 22) Lot Number: 07GD1295;
23)
Lot Number: 07DD3724
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Medline Industries, Inc.,
Mundelein, IL,
Manufacturer: Ventlab Corp., Mocksville, NC.
REASON
Separation from Bushing: The breathing bag may separate from the bushing during
use.
VOLUME OF PRODUCT IN COMMERCE 571,500 packs
DISTRIBUTION
Nationwide
PRODUCT Zoll E Series
Defibrillator with 12 Lead ECG, Automated external defibrillator, Software
Version 3.00 and higher,
CODE
Serial Numbers:
AB05D000031 AB05D000034 AB05F000276 AB05F000277 AB05F000278 AB05F000279
AB05F000280 AB05F000281 AB05F000282 AB05F000283 AB05F000284 AB05F000286
AB05F000287 AB05F000288 AB05F000289 AB05F000290 AB05F000291 AB05F000292
AB05F000293 AB05F000294 AB05F000295 AB05F000296 AB05F000297 AB05F000298
AB05F000299 AB05F000300 AB05F000301 AB05F000302 AB05F000303 AB05F000304
AB05F000305 AB05F000306 AB05F000307 AB05F000308 AB05F000309 AB05F000310
AB05F000311 AB05F000312 AB05F000313 AB05F000314 AB05F000315 AB05F000316
AB05F000317 AB05F000318 AB05F000319 AB05F000320 AB05F000321 AB05F000322
AB05F000323 AB05F000324 AB05F000325 AB05F000326 AB05F000327 AB05F000328
AB05F000329 AB05F000330 AB05F000331 AB05F000332 AB05F000333 AB05F000334
AB05F000335 AB05F000336 AB05F000337 AB05F000338 AB05F000339 AB05F000340
AB05F000341 AB05F000342 AB05F000343 AB05F000344 AB05F000345 AB05F000346
AB05F000347 AB05F000348 AB05F000349 AB05F000350 AB05F000351 AB05F000352
AB05F000353 AB05F000354 AB05F000355 AB05F000356 AB05F000357 AB05F000358
AB05F000359 AB05F000360 AB05F000361 AB05F000362 AB05F000363 AB05F000364
AB05F000365 AB05F000366 AB05F000367 AB05F000368 AB05F000369 AB05F000370
AB05F000371 AB05F000372 AB05F000373 AB05F000374 AB05F000375 AB05F000376
AB05F000377 AB05F000378 AB05F000379 AB05F000380 AB05F000381 AB05F000382
AB05F000384 AB05F000385 AB05F000386 AB05F000387 AB05F000388 AB05F000389
AB05F000390 AB05F000391 AB05F000392 AB05F000393 AB05F000395 AB05F000396
AB05F000397 AB05F000398 AB05F000399 AB05F000401 AB05F000402 AB05F000403
AB05F000404 AB05F000405 AB05F000406 AB05F000407 AB05F000408 AB05F000409
AB05F000411 AB05F000412 AB05F000413 AB05F000414 AB05F000415 AB05F000416
AB05F000417 AB05F000419 AB05F000420 AB05F000421 AB05F000422 AB05F000423
AB05F000424 AB05F000425 AB05F000426 AB05F000427 AB05F000429 AB05F000430
AB05F000431 AB05F000432 AB05F000433 AB05F000434 AB05F000436 AB05F000437
AB05F000438 AB05F000439 AB05F000440 AB05F000441 AB05F000442 AB05F000443
AB05F000444 AB05F000445 AB05F000446 AB05F000447 AB05F000448 AB05F000449
AB05F000450 AB05F000451 AB05F000452 AB05F000453 AB05F000454 AB05F000455
AB05F000456 AB05F000457 AB05F000458 AB05F000459 AB05F000460 AB05F000461
AB05F000462 AB05F000463 AB05F000464 AB05F000465 AB05F000466 AB05F000467
AB05F000468 AB05F000469 AB05F000470 AB05F000471 AB05F000472 AB05F000473
AB05F000474 AB05F000475 AB05F000476 AB05F000477 AB05F000478 AB05F000479
AB05F000480 AB05F000481 AB05F000482 AB05F000483 AB05F000484 AB05F000485
AB05F000486 AB05F000487 AB05F000488 AB05F000489 AB05F000491 AB05F000492
AB05F000493 AB05F000494 AB05F000495 AB05F000496 AB05F000497 AB05F000498
AB05F000499 AB05F000500 AB05F000501 AB05F000502 AB05F000503 AB05F000504
AB05F000505 AB05F000506 AB05F000508 AB05F000511 AB05F000512 AB05F000513
AB05F000514 AB05F000515 AB05F000579 AB05H000516 AB05H000517 AB05H000518
AB05H000519 AB05H000520 AB05H000521 AB05H000522 AB05H000523 AB05H000524
AB05H000525 AB05H000526 AB05H000527 AB05H000528 AB05H000529 AB05H000530
AB05H000531 AB05H000532 AB05H000533 AB05H000534 AB05H000535 AB05H000536
AB05H000537 AB05H000538 AB05H000539 AB05H000540 AB05H000541 AB05H000542
AB05H000543 AB05H000544 AB05H000545 AB05H000546 AB05H000547 AB05H000548
AB05H000549 AB05H000550 AB05H000551 AB05H000552 AB05H000553 AB05H000554
AB05H000555 AB05H000556 AB05H000557 AB05H000558 AB05H000559 AB05H000560
AB05H000561 AB05H000562 AB05H000563 AB05H000564 AB05H000565 AB05I000566
AB05I000567 AB05I000568 AB05I000569 AB05I000570 AB05I000571 AB05I000572
AB05I000574 AB05I000575 AB05I000576 AB05I000577 AB05I000578 AB05I000579
AB05I000580 AB05I000581 AB05I000582 AB05I000583 AB05I000584 AB05I000585
AB05I000586 AB05I000587 AB05I000588 AB05I000589 AB05I000590 AB05I000591
AB05I000592 AB05I000593 AB05I000594 AB05I000595 AB05I000596 AB05I000597
AB05I000598 AB05I000599 AB05I000601 AB05I000602 AB05I000603 AB05I000604
AB05I000605 AB05I000606 AB05I000607 AB05I000608 AB05I000609. AB05I000610
AB05I000611 AB05I000612 AB05I000613 AB05I000614 AB05I000615 AB05I000616
AB05I000617 AB05I000618 AB05I000619 AB05I000620 AB05I000621 AB05I000622
AB05I000623 AB05I000624 AB05I000625 AB05I000626 AB05I000627 AB05I000628
AB05I000629 AB05I000630 AB05I000631 AB05I000632 AB05I000633 AB05I000634
AB05I000635 AB05I000636 AB05I000637 AB05I000638 AB05I000639 AB05I000640
AB05I000641 AB05I000642 AB05I000643 AB05I000644 AB05I000645 AB05I000646
AB05I000647 AB05I000648 AB05I000649 AB05I000650 AB05I000651 AB05I000652
AB05I000653 AB05I000654 AB05I000655 AB05I000656 AB05I000657 AB05I000658
AB05I000659 AB05I000660 AB05I000661 AB05I000662 AB05I000663 AB05I000665
AB05I000666 AB05I000667 AB05I000673 AB05I000674 AB05I000675 AB05I000676
AB05I000677 AB05I000678 AB05I000679 AB05I000680 AB05I000681 AB05I000682
AB05I000685 AB05I000686 AB05I000687 AB05I000688 AB05I000689 AB05I000690
AB05I000692 AB05I000694 AB05I000695 AB05I000696 AB05I000697 AB05I000698
AB05I000699 AB05I000700 AB05I000701 AB05I000702 AB05I000704 AB05I000705
AB05I000706 AB05I000707 AB05I000708 AB05I000709 AB05I000710 AB05I000711
AB05J000716 AB05J000717 AB05J000718 AB05J000719 AB05J000726 AB05J000727
AB05J000734 AB05J000736 AB05J000737 AB05J000738 AB05J000740 AB05K000741
AB05K000742 AB05K000743 AB05K000744 AB05K000745 AB05K000746 AB05K000747
AB05K000748 AB05K000749 AB05K000750 AB05K000751 AB05K000752 AB05K000753
AB05K000754 AB05K000755 AB05K000756 AB05K000757 AB05K000758 AB05K000759
AB05K000760 AB05K000761 AB05K000762 AB05K000763 AB05K000764 AB05K000765
AB05K000766 AB05K000767 AB05K000768 AB05K000769 AB05K000770 AB05K000771
AB05K000772 AB05K000773 AB05K000774 AB05K000775 AB05K000776 AB05K000777
AB05K000778 AB05K000779 AB05K000780 AB05K000781 AB05K000782 AB05K000783
AB05K000784 AB05K000785 AB05K000786 AB05K000787 AB05K000788 AB05K000789
AB05K000790 AB05K000791 AB05K000792 AB05K000793 AB05K000794 AB05K000795
AB05K000796 AB05K000797 AB05K000798 AB05K000799 AB05K000800 AB05K000801
AB05K000802 AB05K000803 AB05K000804 AB05K000805 AB05K000806 AB05K000807
AB05K000808 AB05K000809 AB05K000810 AB05K000811 AB05K000812 AB05K000813
AB05K000814 AB05K000815 AB05K000816 AB05K000817 AB05K000818 AB05K000819
AB05K000820 AB05K000821 AB05K000822 AB05K000823 AB05K000824 AB05K000825
AB05K000826 AB05K000827 AB05K000828 AB05K000829 AB05K000830 AB05K000831
AB05K000832 AB05K000833 AB05K000834 AB05K000835 AB05K000836 AB05K000837
AB05K000838 AB05K000839 AB05K000840 AB05K000841 AB05K000842 AB05K000843
AB05K000844 AB05K000845 AB05K000846 AB05K000847 AB05K000848 AB05K000849
AB05K000850 AB05K000851 AB05K000852 AB05K000853 AB05K000854 AB05K000855
AB05K000856 AB05K000859 AB05K000860 AB05K000861 AB05L000876 AB05L000877
AB05L000878 AB05L000879 AB05L000880 AB05L000881 AB05L000882 AB05L000883
AB05L000884 AB05L000885 AB05L000886 AB05L000887 AB05L000888 AB05L000889
AB05L000890 AB05L000891 AB05L000892 AB05L000893 AB05L000894 AB05L000895
AB05L000896 AB05L000897 AB05L000898 AB05L000899 AB05L000900 AB05L000901
AB05L000902 AB05L000903 AB05L000904 AB05L000905 AB05L000906 AB05L000907
AB05L000908 AB05L000909 AB05L000910 AB05L000911 AB05L000912 AB05L000913
AB05L000914 AB05L000915 AB05L000916 AB05L000917 AB05L000918 AB05L000919
AB05L000925 AB05L000926 AB05L000927 AB05L000928 AB05L000929 AB05L000930
AB05L000931 AB05L000932 AB05L000933 AB05L000934 AB05L000935 AB05L000936
AB05L000937 AB05L000938 AB05L000939 AB05L000940 AB05L000941 AB05L000942
AB05L000943 AB05L000944 AB05L000945 AB05L000946 AB05L000947 AB05L000948
AB05L000949 AB05L000950 AB05L000951 AB05L000952 AB05L000953 AB05L000954
AB05L000955 AB05L000956 AB05L000957 AB05L000958 AB06A000959 AB06A000960
AB06A000961 AB06A000962 AB06A000964 AB06A000965 AB06A000966 AB06A000967
AB06A000968 AB06A000969 AB06A000970 AB06A000971 AB06A000972 AB06A000973
AB06A000974 AB06A000975 AB06A000976 AB06A000977 AB06A000978 AB06A000979
AB06A000980 AB06A000981 AB06A000982 AB06A000983 AB06A000984 AB06A000985
AB06A000986 AB06A000987 AB06A000988 AB06A000989 AB06A000990 AB06A000991
AB06A000992 AB06A000993 AB06A000994 AB06A000995 AB06A000996 AB06A000997
AB06A000998 AB06A000999 AB06A001000 AB06A001001 AB06A001002 AB06A001003
AB06A001004 AB06A001005 AB06A001006 AB06A001007 AB06A001008 AB06A001009
AB06A001010 AB06A001011 AB06A001012 AB06A001013 AB06A001014 AB06A001015
AB06A001016 AB06A001017 AB06A001018 AB06A001019 AB06A001020 AB06A001021
AB06A001022 AB06A001023 AB06A001024 AB06A001025 AB06A001026 AB06A001027
AB06A001028 AB06A001029 AB06A001030 AB06A001031 AB06A001032 AB06A001033
AB06A001034 AB06A001035 AB06A001036 AB06A001037 AB06A001038 AB06A001039
AB06A001040 AB06A001041 AB06A001042 AB06A001043 AB06A001044 AB06A001045
AB06A001046 AB06A001047 AB06A001048 AB06A001049 AB06A001050 AB06A001051
AB06A001052 AB06A001053 AB06A001054 AB06A001055 AB06A001056 AB06A001057
AB06A001058 AB06A001059 AB06A001060 AB06A001061 AB06A001062 AB06A001063
AB06A001064 AB06A001065 AB06A001066 AB06A001067 AB06A001068 AB06A001069
AB06B001071 AB06B001073 AB06B001074 AB06B001075 AB06B001076 AB06B001077
AB06B001078 AB06B001079 AB06B001080 AB06B001083 AB06B001084 AB06B001085
AB06B001086 AB06B001087 AB06B001088 AB06B001089 AB06B001090 AB06B001091
AB06B001092 AB06B001093 AB06B001094 AB06B001095 AB06B001096 AB06B001097
AB06B001098 AB06B001099 AB06B001100 AB06B001101 AB06B001102 AB06B001103
AB06B001104 AB06B001105 AB06B001106 AB06B001107 AB06B001108 AB06B001109
AB06B001110 AB06B001111 AB06B001112 AB06B001113 AB06B001114 AB06B001115
AB06B001116 AB06B001117 AB06B001118 AB06B001119 AB06B001120 AB06B001121
AB06B001122 AB06B001123 AB06B001124 AB06B001125 AB06B001126 AB06B001127
AB06B001128 AB06B001129 AB06B001130 AB06B001131 AB06B001132 AB06B001133
AB06B001134 AB06B001135 AB06B001136 AB06B001137 AB06B001138 AB06B001139
AB06B001140 AB06B001141 AB06B001142 AB06B001144 AB06B001145 AB06B001146
AB06B001147 AB06B001148 AB06B001149 AB06B001150 AB06B001151 AB06B001152
AB06B001155 AB06B001156 AB06B001157 AB06B001159 AB06B001160 AB06B001161
AB06B001162 AB06B001163 AB06B001164 AB06B001165 AB06B001166 AB06B001167
AB06B001168 AB06B001169 AB06B001170 AB06B001171 AB06B001172 AB06B001173
AB06B001174 AB06B001175 AB06B001176 AB06B001177 AB06B001178 AB06B001179
AB06B001180 AB06B001181 AB06C001182 AB06C001183 AB06C001184 AB06C001185
AB06C001186 AB06C001187 AB06C001196 AB06C001197 AB06C001198 AB06C001199
AB06C001200 AB06C001201 AB06C001202 AB06C001203 AB06C001204 AB06C001205
AB06C001206 AB06C001207 AB06C001209 AB06C001216 AB06C001217 AB06C001218
AB06C001219 AB06C001228 AB06C001236 AB06C001237 AB06C001238 AB06C001239
AB06C001240 AB06C001241 AB06C001242 AB06C001243 AB06C001244 AB06C001245
AB06C001246 AB06C001247 AB06C001248 AB06C001249 AB06C001250 AB06C001251
AB06C001252 AB06C001253 AB06C001254 AB06C001255 AB06C001256 AB06C001257
AB06C001258 AB06C001259 AB06C001260 AB06C001261 AB06C001262 AB06C001263
AB06C001264 AB06C001265 AB06C001266 AB06C001267 AB06C001268 AB06C001269
AB06C001270 AB06C001271 AB06C001272 AB06C001273 AB06C001275 AB06C001278
AB06C001279 AB06C001280 AB06C001281 AB06C001282 AB06C001283 AB06C001284
AB06C001285 AB06C001286 AB06C001287 AB06C001288 AB06C001289 AB06C001290
AB06C001291 AB06C001292 AB06C001293 AB06C001294 AB06C001295 AB06C001296
AB06C001297 AB06C001298 AB06C001299 AB06C001300 AB06C001301 AB06C001302
AB06C001303 AB06C001304 AB06C001305 AB06C001306 AB06C001307 AB06C001311
AB06C001318 AB06C001319 AB06C001320 AB06C001321 AB06C001322 AB06C001323
AB06C001324 AB06C001326 AB06C001327 AB06C001328 AB06C001329 AB06C001330
AB06C001331 AB06C001332 AB06C001333 AB06C001334 AB06C001335 AB06C001336
AB06C001337 AB06C001338 AB06C001339 AB06C001340 AB06C001343 AB06C001344
AB06C001346 AB06C001347 AB06C001348 AB06C001349 AB06C001350 AB06C001351
AB06C001352 AB06C001353 AB06C001354 AB06C001355 AB06C001356 AB06C001357
AB06C001358 AB06C001359 AB06C001360 AB06C001361 AB06C001362 AB06C001363
AB06C001364 AB06C001365 AB06C001366 AB06C001367 AB06C001368 AB06C001369
AB06C001370 AB06C001371 AB06C001372 AB06C001373 AB06C001374 AB06C001375
AB06C001376 AB06C001377 AB06D001385 AB06D001386 AB06D001387 AB06D001388
AB06D001389 AB06D001390 AB06D001391 AB06D001392 AB06D001393 AB06D001394
AB06D001395 AB06D001396 AB06D001397 AB06D001398 AB06D001399 AB06D001400
AB06D001401 AB06D001402 AB06D001403 AB06D001404 AB06D001405 AB06D001406
AB06D001407 AB06D001408 AB06D001409 AB06D001410 AB06D001411 AB06D001412
AB06D001413 AB06D001414 AB06D001415 AB06D001416 AB06D001417 AB06D001418
AB06D001419 AB06D001420 AB06D001421 AB06D001422 AB06D001423 AB06D001424
AB06D001425 AB06D001426 AB06D001427 AB06D001428 AB06D001429 AB06D001430
AB06D001431 AB06D001432 AB06D001433 AB06D001434 AB06D001435 AB06D001436
AB06D001437 AB06D001438 AB06D001439 AB06D001440 AB06D001441 AB06D001442
AB06D001443 AB06D001444 AB06D001445 AB06D001446 AB06D001447 AB06D001453
AB06D001454 AB06D001455 AB06D001456 AB06D001457 AB06D001458 AB06D001459
AB06D001460 AB06D001461 AB06D001462 AB06D001463 AB06D001464 AB06D001465
AB06D001466 AB06D001467 AB06D001468 AB06D001469 AB06D001470 AB06D001471
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AB07H004983 AB07H004984 AB07H004985 AB07H004986 AB07H004987 AB07H004988
AB07H004989 AB07H004990 AB07H004991 AB07H004992 AB07H004993 AB07H004994
AB07H004995 AB07H004997 AB07H004998 AB07H004999 AB07H005000 AB07H005001
AB07H005002 AB07H005003 AB07H005004 AB07H005005 AB07H005006 AB07H005007
AB07H005008 AB07H005010 AB07H005011 AB07H005012 AB07H005013 AB07H005014
AB07H005022 AB07H005023 AB07H005024 AB07H005025 AB07H005026 AB07H005027
AB07H005028 AB07H005029 AB07H005030 AB07H005031 AB07H005032 AB07H005033
AB07H005034 AB07H005035 AB07H005036 AB07H005037 AB07H005038 AB07H005039
AB07H005040 AB07H005041 AB07H005042 AB07H005043 AB07H005044 AB07H005045
AB07H005046 AB07H005047 AB07H005048 AB07H005049 AB07H005050 AB07H005051
AB07H005053 AB07H005054 AB07H005055 AB07H005056 AB07H005057 AB07H005058
AB07H005059 AB07H005060 AB07H005061 AB07H005062 AB07H005063 AB07H005064
AB07H005065 AB07H005066 AB07H005067 AB07H005068 AB07H005069 AB07H005070
AB07H005071 AB07H005072 AB07H005073 AB07H005074 AB07H005075 AB07H005076
AB07H005077 AB07H005078 AB07H005079 AB07H005080 AB07H005081 AB07H005083
AB07H005084 AB07H005085 AB07H005086 AB07H005087 AB07H005088 AB07H005089
AB07H005090 AB07H005091 AB07H005092 AB07H005093 AB07H005094 AB07H005095
AB07H005096 AB07H005097 AB07H005098 AB07H005099 AB07H005100 AB07H005101
AB07H005107 AB07H005108 AB07H005114 AB07H005115 AB07H005116 AB07H005117
AB07H005118 AB07H005119 AB07H005120 AB07H005121 AB07H005122 AB07H005123
AB07H005124 AB07H005125 AB07H005126 AB07H005127 AB07H005128 AB07H005129
AB07H005130 AB07H005131 AB07H005132 AB07H005133 AB07H005134 AB07H005135
AB07H005136 AB07H005137 AB07H005138 AB07H005139 AB07H005140 AB07H005141
AB07H005142 AB07H005143 AB07H005144 AB07H005145 AB07H005146 AB07H005147
AB07H005148 AB07H005149 AB07H005151 AB07H005152 AB07H005153 AB07H005154
AB07H005155 AB07H005156 AB07H005157 AB07H005158 AB07I005209 AB07I005210
AB07I005211 AB07I005212 AB07I005213 AB07I005214 AB07I005215 AB07I005216
AB07I005217 AB07I005218 AB07I005219 AB07I005220 AB07I005221 AB07I005222
AB07I005223 AB07I005224 AB07I005225 AB07I005226 AB07I005227 AB07I005228
AB07I005229 AB07I005230 AB07I005231 AB07I005232 AB07I005233 AB07I005234
AB07I005235 AB07I005236 AB07I005237 AB07I005238 AB07I005239 AB07I005240
AB07I005243 AB07I005244 AB07I005245 AB07I005246 AB07I005247 AB07I005248
AB07I005249 AB07I005250 AB07I005251 AB07I005252 AB07I005253 AB07I005254
AB07I005255 AB07I005256 AB07I005257 AB07I005258 AB07I005259 AB07I005260
AB07I005262 AB07I005263 AB07I005264 AB07I005265 AB07I005268 AB07I005269
AB07I005270 AB07I005271 AB07I005272 AB07I005273 AB07I005274 AB07I005277
AB07I005281 AB07I005282 AB07I005283 AB07I005284 AB07I005285 AB07I005286
AB07I005287 AB07I005288 AB07I005289 AB07I005290 AB07I005291 AB07I005292
AB07I005293 AB07I005294 AB07I005295 AB07I005296 AB07I005297 AB07I005298
AB07I005299 AB07I005300 AB07I005301 AB07I005302 AB07I005303 AB07I005304
AB07I005305 AB07I005306 AB07I005307 AB07I005308 AB07I005309 AB07I005310
AB07I005311 AB07I005312 AB07I005313 AB07I005314 AB07I005315 AB07I005316
AB07I005317 AB07I005318 AB07I005319 AB07I005320 AB07I005321 AB07I005322
AB07I005323 AB07I005324 AB07I005327 AB07I005328 AB07I005329 AB07I005330
AB07I005331 AB07I005332 AB07I005333 AB07I005334 AB07I005335 AB07I005336
AB07I005337 AB07I005338 AB07I005339 AB07I005340 AB07I005341 AB07I005342
AB07I005343 AB07I005344 AB07I005345 AB07I005346 AB07I005363 AB07I005364
AB07I005365 AB07I005366 AB07I005368 AB07I005369 AB07I005370 AB07I005372
AB07I005373 AB07I005374 AB07I005375 AB07I005376 AB07I005377 AB07I005378
AB07I005379 AB07I005380 AB07I005381 AB07I005382 AB07I005383 AB07I005384
AB07I005385 AB07I005386 AB07I005387 AB07I005388 AB07I005389 AB07I005390
AB07I005393 AB07I005394 AB07I005396 AB07I005397 AB07I005398 AB07I005399
AB07I005400 AB07I005402 AB07I005403 AB07I005404 AB07I005405 AB07I005406
AB07I005407 AB07I005408 AB07I005409 AB07I005410 AB07I005412 AB07I005413
AB07I005414 AB07I005415 AB07I005416 AB07I005417 AB07I005418 AB07I005419
AB07I005420 AB07I005421 AB07I005422 AB07I005423 AB07I005424 AB07I005426
AB07I005428 AB07I005429 AB07I005430 AB07I005431 AB07I005432 AB07I005434
AB07I005435 AB07I005436 AB07I005437 AB07I005438 AB07I005439 AB07I005440
AB07I005441 AB07I005443 AB07I005444 AB07I005445 AB07I005446 AB07I005447
AB07I005449 AB07I005450 AB07I005451 AB07I005452 AB07I005453 AB07I005454
AB07I005455 AB07I005456 AB07I005457 AB07I005458 AB07I005459 AB07I005460
AB07I005461 AB07I005462 AB07I005463 AB07I005464 AB07I005466 AB07I005467
AB07I005470 AB07I005471 AB07I005472 AB07I005473 AB07I005474 AB07I005475
AB07I005476 AB07I005477 AB07I005478 AB07I005479 AB07I005480 AB07I005481
AB07I005482 AB07I005483 AB07I005484 AB07I005485 AB07I005486 AB07I005487
AB07I005488 AB07I005489 AB07I005490 AB07I005491 AB07I005493 AB07I005494
AB07I005495 AB07I005496 AB07I005497 AB07I005499 AB07I005500 AB07I005501
AB07I005502 AB07I005503 AB07I005504 AB07I005505 AB07I005506 AB07I005507
AB07I005508 AB07I005509 AB07I005510 AB07I005511 AB07I005512 AB07I005513
AB07I005514 AB07I005515 AB07I005517 AB07I005518 AB07I005519 AB07I005520
AB07I005523 AB07I005524 AB07I005525 AB07I005526 AB07I005527 AB07I005528
AB07I005529 AB07I005530 AB07I005531 AB07I005532 AB07I005537 AB07I005539
AB07I005541 AB07I005542 AB07I005543 AB07I005544 AB07I005545 AB07I005546
AB07I005547 AB07I005548 AB07I005549 AB07I005551 AB07I005552 AB07I005553
AB07I005554 AB07I005555 AB07I005556 AB07I005557 AB07I005558 AB07I005559
AB07I005560 AB07I005561 AB07I005562 AB07I005563 AB07I005564 AB07I005566
AB07I005567 AB07I005568 AB07I005570 AB07I005571 AB07I005572 AB07I005573
AB07I005574 AB07I005575 AB07I005576 AB07I005577 AB07I005578 AB07I005579
AB07I005581 AB07I005582 AB07I005583 AB07I005584 AB07I005585 AB07I005586
AB07I005587 AB07I005588 AB07I005589 AB07I005590 AB07I005591 AB07I005593
AB07I005594 AB07I005595 AB07I005596 AB07I005597 AB07I005598 AB07I005599
AB07I005600 AB07I005601 AB07I005602 AB07I005603 AB07I005604 AB07I005605
AB07I005606 AB07I005608 AB07I005610 AB07I005611 AB07I005614 AB07I005615
AB07I005616 AB07I005617 AB07I005618 AB07I005619 AB07I005620 AB07I005621
AB07I005622 AB07I005623 AB07I005625 AB07J005626 AB07J005627 AB07J005628
AB07J005629 AB07J005630 AB07J005631 AB07J005632 AB07J005633 AB07J005634
AB07J005635 AB07J005636 AB07J005637 AB07J005638 AB07J005639 AB07J005640
AB07J005641 AB07J005642 AB07J005643 AB07J005644 AB07J005645 AB07J005646
AB07J005647 AB07J005648 AB07J005649 AB07J005650 AB07J005651 AB07J005652
AB07J005653 AB07J005656 AB07J005657 AB07J005658 AB07J005659 AB07J005660
AB07J005661 AB07J005662 AB07J005663 AB07J005664 AB07J005665 AB07J005666
AB07J005667 AB07J005668 AB07J005669 AB07J005670 AB07J005671 AB07J005672
AB07J005673 AB07J005674 AB07J005675 AB07J005676 AB07J005677 AB07J005678
AB07J005679 AB07J005680 AB07J005681 AB07J005682 AB07J005683 AB07J005684
AB07J005685 AB07J005686 AB07J005687 AB07J005688 AB07J005690 AB07J005691
AB07J005692 AB07J005693 AB07J005694 AB07J005695 AB07J005696 AB07J005697
AB07J005698 AB07J005699 AB07J005700 AB07J005701 AB07J005702 AB07J005703
AB07J005704 AB07J005705 AB07J005708 AB07J005709 AB07J005710 AB07J005711
AB07J005712 AB07J005713 AB07J005714 AB07J005715 AB07J005716 AB07J005717
AB07J005718 AB07J005719 AB07J005720 AB07J005721 AB07J005722 AB07J005723
AB07J005724 AB07J005725 AB07J005726 AB07J005727 AB07J005728 AB07J005729
AB07J005730 AB07J005731 AB07J005732 AB07J005733 AB07J005734 AB07J005735
AB07J005736 AB07J005737 AB07J005738 AB07J005739 AB07J005740 AB07J005741
AB07J005742 AB07J005743 AB07J005744 AB07J005745 AB07J005746 AB07J005747
AB07J005748 AB07J005749 AB07J005750 AB07J005751 AB07J005752 AB07J005753
AB07J005754 AB07J005755 AB07J005756 AB07J005757 AB07J005758 AB07J005759
AB07J005760 AB07J005761 AB07J005762 AB07J005763 AB07J005767 AB07J005768
AB07J005769 AB07J005771 AB07J005772 AB07J005773 AB07J005777 AB07J005778
AB07J005779 AB07J005780 AB07J005781 AB07J005782 AB07J005783 AB07J005784
AB07J005785 AB07K005840 AB07K005841 AB07K005842 AB07K005843 AB07K005844
AB07K005845 AB07K005846 AB07K005847 AB07K005849 AB07K005850 AB07K005852
AB07K005853 AB07K005854 AB07K005856 AB07K005857 AB07K005858 AB07K005859
AB07K005860 AB07K005861 AB07K005862 AB07K005864 AB07K005867 AB07K005868
AB07K005869 AB07K005870 AB07K005871 AB07K005872 AB07K005873 AB07K005874
AB07K005879 AB07K005880 AB07K005883 AB07K005885 AB07K005887 AB07K005888
AB07K005889 AB07K005890 AB07K005891 AB07K005892 AB07K005893 AB07K005894
AB07K005895 AB07K005896 AB07K005898 AB07K005899 AB07K005900 AB07K005902
AB07K005903 AB07K005904 AB07K005905 AB07K005906 AB07K005907 AB07K005908
AB07K005909 AB07K005910 AB07K005911 AB07K005912 AB07K005913 AB07K005915
AB07K005916 AB07K005917 AB07K005918 AB07K005919 AB07K005921 AB07K005922
AB07K005923 AB07K005924 AB07K005925 AB07K005927 AB07K005928 AB07K005929
AB07K005930 AB07K005931 AB07K005932 AB07K005933 AB07K005934 AB07K005935
AB07K005936 AB07K005937 AB07K005938 AB07K005939 AB07K005940 AB07K005944
AB07K005947 AB07K005948 AB07K005949 AB07K005950 AB07K005951 AB07K005952
AB07K005953 AB07K005954 AB07K005955 AB07K005956 AB07K005957 AB07K005958
AB07K005959 AB07K005960 AB07K005961 AB07K005962 AB07K005963 AB07K005964
AB07K005965 AB07K005966 AB07L005968 AB07L005969 AB07L005970 AB07L005972
AB07L005973 AB07L005974 AB07L005975 AB07L005976 AB07L005977 AB07L005978
AB07L005979 AB07L005980 AB07L005981 AB07L005982 AB07L005983 AB07L005984
AB07L005985 AB07L005986 AB07L005987 AB07L005988 AB07L005989 AB07L005990
AB07L005991 AB07L005992 AB07L005993 AB07L005994 AB07L005995 AB07L005996
AB07L005998 AB07L005999 AB07L006000 AB07L006001 AB07L006002 AB07L006003
AB07L006004 AB07L006005 AB07L006006 AB07L006007 AB07L006008 AB07L006009
AB07L006010 AB07L006011 AB07L006012 AB07L006013 AB07L006014 AB07L006015
AB07L006017 AB07L006018 AB07L006019 AB07L006020 AB07L006023 AB07L006024
AB07L006025 AB07L006027 AB07L006028 AB07L006029 AB07L006030 AB07L006031
AB07L006032 AB07L006033 AB07L006034 AB07L006035 AB07L006036 AB07L006038
AB07L006039 AB07L006040 AB07L006041 AB07L006042 AB07L006043 AB07L006044
AB07L006045 AB07L006046 AB07L006047 AB07L006048 AB07L006049 AB07L006052
AB07L006053 AB07L006054 AB07L006055 AB07L006056 AB07L006057 AB07L006058
AB07L006060 AB07L006063 AB07L006067 AB07L006071 AB07L006072 AB07L006073
AB07L006075 AB07L006079 AB07L006080 AB07L006081 AB07L006082 AB07L006083
AB07L006084 AB07L006085 AB07L006086 AB07L006087 AB07L006088 AB07L006089
AB07L006090 AB07L006091 AB07L006093 AB07l006095 AB07L006096 AB07L006098
AB07L006099 AB07L006100 AB07L006101 AB07L006102 AB07L006103 AB07L006104
AB07L006105 AB07L006106 AB07L006107 AB07L006108 AB07L006109 AB07L006110
AB07L006111 AB07L006112 AB07L006113 AB07L006114 AB07L006115 AB07L006116
AB07L006118 AB07L006119 AB07L006120 AB07L006121 AB07L006122 AB07L006123
AB07L006125 AB07L006126 AB07L006127 AB07L006128 AB07L006129 AB07L006130
AB07L006132 AB07L006133 AB07L006134 AB07L006135 AB07L006136 AB07L006137
AB07L006138 AB07L006139 AB07L006140 AB07L006141 AB07L006142 AB07L006143
AB07L006144 AB07L006146 AB07L006147 AB07L006149 AB07L006151 AB07L006152
AB07L006153 AB07L006154 AB07L006155 AB07L006156 AB07L006157 AB07L006158
AB07L006160 AB07L006161 AB07L006163 AB07L006164 AB07L006165 AB07L006166
AB07L006167 AB07L006169 AB07L006172 AB07L006173 AB07L006174 AB07L006175
AB07L006176 AB07L006177 AB07L006178 AB07L006179 AB07L006181 AB07L006182
AB07L006184 AB07L006186 AB07L006187 AB07L006188 AB07L006190 AB07L006193
AB08A006203 AB08A006206 AB08A006207 AB08A006210 AB08A006213 AB08A006214
AB08A006216 AB08A006219 AB08A006220 AB08A006221 AB08A006223 AB08A006224
AB08A006227 AB08A006228
RECALLING FIRM/MANUFACTURER Zoll
Medical Corporation, World Wide Headquarters, Chelmsford, MA,
REASON
Incorrect Patient Records: Patient records that have been stored, then later
transmitted or printed may not be the correct record. Records that are
transmitted or printed immediately following acquisition are correct.
VOLUME
OF PRODUCT IN COMMERCE 5,018 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT Reusable
Ohmeda Compatible Finger Clip Sensor, Model Number: E403-02, Product Code:
PS2225. To monitor oxygen saturation level of patients under doctor's care,
CODE
Serial
Numbers: YE508/001, YE508/002, YE508/003, YE508/004, YE508/005, YE508/006,
YE508/007, YE508/008, YE508/009, YE508/010; ZC502/001, ZC502/002, ZC502/003,
ZC502/004, ZC502/005, ZC502/006; ZG512/001, ZG512/002, ZG512/003, ZG512/004,
ZG512/005, ZG512/006, ZG512/007, ZG512/008, ZG512/009, ZG512/010, ZG512/011,
ZG512/012, ZG512/013, ZG512/014, ZG512/015; PA514/001, PA514/002, PA514/003,
PA514/004, PA514/005, PA514/006, PA514/006, PA514/007, PA514/008, PA514/009,
PA514/010; PA515/001, PA515/002, PA515/003, PA515/004, PA515/005, PA515/006,
PA515/007, PA515/008, PA515/009, PA515/010, PA515/011, PA515/012, PA515/013,
PA515/014, PA515/015, PA515/016, PA515/017, PA515/018, PA515/019, PA515/020,
PA515/021, PA515/022, PA515/023, PA515/024, PA515/025, PA515/026, PA515/027,
PA515/028, PA515/029, PA515/030, PA515/031, PA515/032, PA515/033, PA515/034 and
PA515/035
RECALLING FIRM/MANUFACTURER Kentec Medical Inc.,
Irvin, CA,
REASON Incompatible components: The Finger Clip
Sensors - with a Serial Number prefix of PA514, PA515, YE508, ZC502 and ZG512 -
are missing an additional diode and higher resistor in its existing
configuration making them inoperable when used to interface with those Ohmeda
Tuffsat monitors previously re-configured by Ohmeda to include a detection
circuit for diodes.
VOLUME OF PRODUCT IN COMMERCE 41 units
DISTRIBUTION
Nationwide
PRODUCT
a)
INTELECT INTELECT XT, Model No. 2760. Made in the USA,
b) INTELECT LEGEND
XT, Model No. 2763, Made in the USA,
c) VECTRA GENISYS, Model No. 2761, Made
in the USA, d) VECTRA GENISYS, Model No. 2764, Made in the USA, e) VECTRA
TRANSPORTABLE, Model No. 2783, Made in the USA,
f) INTELECT VET, Model No.
2756, Made in the USA, g) INTELECT VET, Model No. 2843, Made in the USA, h)
INTELECT ADVANCED, Model No. 2752CC. Made in the USA, Not for sale in the U.S.A,
i)
INTELECT ADVANCED, Model No. 2755CS, Made in the USA, Not for sale in the U.S.A,
j) INTELECT ADVANCED, Model No. 2762CC. Made in the USA, Not for sale in the
U.S.A,
k) INTELECT ADVANCED, Model No. 2765CS. Made in the USA, Not for sale
in the U.S.A,
l) INTELECT ADVANCED, Model No. 2772MC. Made in the USA, Not
for sale in the U.S.A,
m) INTELECT ADVANCED STIM, Model No. 2773MS. Made in
the USA, Not for sale in the U.S.A,
n) INTELECT MOBILE COMBO, Model No. 2778. Made in the USA, Not for sale in
the U.S.A,
o) INTELECT MOBILE, Model No. 2777. Made in the USA, Not for sale
in the U.S.A,
CODE
a) Serial numbers 1000 – 5886;
b)
Serial numbers 1000 – 1683;
c) Serial numbers 1000 – 5047;
d) Serial
numbers 1000 – 1713;
e) Serial numbers 1000 – 1615;
f) Serial numbers
1000 – 1140;
g) Serial numbers 1000 – 1015;
h) Serial numbers 1000 –
1079;
i) Serial numbers 1000 – 1017;
j) Serial numbers 1000 – 3993;
k)
Serial numbers 1000 - 1452;
l) Serial numbers 1000 - 3002;
m) Serial
numbers 1000 - 2018;
n) Serial numbers 1000 - 3541;
o) Serial numbers 1000
- 2799
RECALLING FIRM/MANUFACTURER Chattanooga Corp Inc.,
Hixson, TN,
REASON Device malfunction: causing electric
shock and burn.
VOLUME OF PRODUCT IN COMMERCE 20,000 units
DISTRIBUTION
Nationwide and Internationally
PRODUCT Solar HA
Humeral Stem with Plasma Coating 7mm to 17 mm Product Catalog Number: 5351-4307,
7mm; 5351-4308, 8mm; 5351-4309, 9mm; 5351-4310, 10mm; 5351-4311, 11mm;
5351-4312, 12mm; 5351-4313, 13mm; 5351-4314, 14mm; 5351-4315, 15mm; 5351-4316,
16mm; and 5351-4317, 17mm. For use as a Shoulder Replacement. Made in USA,
CODE
All Lot Codes for the above catalog numbers.
RECALLING
FIRM/MANUFACTURER Stryker Howmedica Osteonics Corp., Mahwah, NJ.
REASON
Delamination: Loosening of the titanium plasma coating on the product was
observed on twelve non-distributed units.
VOLUME OF PRODUCT IN
COMMERCE 915 units
DISTRIBUTION Nationwide
PRODUCT Agfa HeartLab
Cardiovascular DICOMstore, Model # L9M8E. The software is used in the Agfa
HeartLab Cardiovascular System,
CODE Software version:
2.04.40.00
RECALLING FIRM/MANUFACTURER
Recalling Firm:
AGFA Corp., Greenville, SC,
Manufacturer: Heartlab, Inc.,
Westerly, RI. F
REASON Misidentification: The
electrocardiogram (ECG) data of one patient is misidentified as the data of
another patient.
VOLUME OF PRODUCT IN COMMERCE 43 units
DISTRIBUTION
Nationwide and Canada
PRODUCT Agfa HeartLab
Cardiovascular Results Management Product, Model Number: L58RZ and L9MWQ, CODE
Version: 2.03 and 2.04
RECALLING FIRM/MANUFACTURER
Recalling
Firm: AGFA Corp., Greenville, SC,
Manufacturer: Heartlab,
Inc., Westerly, RI.
REASON Incorrect Results: Erroneous
echocardiographic measurement values due to mathematical formula being mis-configured.
VOLUME
OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION
Nationwide
PRODUCT IMPAX® 6.2.1
Network Gateway Server, License Key. Catalog # ABC. The product is used to
transfer medical imaging data,
CODE Code EXEGE000
RECALLING
FIRM/MANUFACTURER AGFA Corp., Greenville, SC,
REASON
Failure of Data Transmission: No imaging data could be transmitted by the
device, because a key value needed for data transmission was incorrectly entered
in the affected units by AGFA Healthcare.
VOLUME OF PRODUCT IN
COMMERCE 12 units
DISTRIBUTION Nationwide
PRODUCT Dimension
Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451),
CODE
Lot number GB9021 exp 2009-01-21 and Lot number GB9029 exp 2009-01-29
RECALLING
FIRM/MANUFACTURER Siemens Healthcare Diagnostics, Inc., Newark, DE, .
REASON
False Results: The product may exhibit falsely elevated results. The affected
lots demonstrate sporadic variability in recovery of calibrator and quality
control; therefore this issue may not be readily detected upon calibration or
during routine processing of Quality Control.
VOLUME OF PRODUCT IN
COMMERCE 1,631 cartons
DISTRIBUTION Nationwide,
Germany, Singapore, Canada, Japan and AE
WEEK ENDING JULY 12
PRODUCT
1)
Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and
accessories; Model Number: EX060603CD;
2) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060403CD;
3) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060803CD;
4) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070403CD;
5) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070603CD;
6) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080403CD;
7) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080401CD;
8) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080803CD;
9) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080601CD;
10) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100401CD;
11) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090603CD;
12) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070803CD;
13) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100601CD;
14) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060303CD;
15) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090401CD;
16) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX 070303CD;
17) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060401CD;
18) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090601CD;
19) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100403CD;
20) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060601CD;
21) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080303CD;
22) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070401CD;
23) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060801CD;
24) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070203CD;
25) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100603CD;
26) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070601CD;
27) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100801CD;
28) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080301CD;
29) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090403CD;
30) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080801CD;
31) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060203CD;
32) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070801CD;
33) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX080203CD;
34) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100303CD;
35) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090301CD;
36) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070301CD;
37) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100301CD;
38) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100903CD;
39) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060301CD;
40) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100803CD;
41) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090803CD;
42) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090303CD;
43) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100201CD;
44) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090801CD;
45) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090201CD;
46) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX060201CD;
47) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100203CD;
48) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX090203CD;
49) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX070201CD;
50) Edwards LifeStent FlexStar Biliary Stent System; Biliary catheter and accessories; Model Number: EX100901CD;
51) Edwards LifeStent FlexStar Biliary Stent System; Biliary
catheter and accessories; Model Number: EX080603CD; CODE
1) Lot Numbers: FR6F0111 (Exp 2008/06),
FR6G0120 (Exp 2008/08), FR6G0121 (Exp 2008/08), FR6H0135 (Exp 2008/08),
FR6H0182 (Exp 2008/08) and FR6H0192 (Exp 2008/08);
2) Lot Numbers: FR6G0118
(2008/07), FR6G0119 (2008/08), FR6H0137 (Exp 2008/08), FR6H0194 (Exp
2008/08) and FR6H0203 (Exp 2008/08);
3) Lot Numbers: FR6G0122, (Exp 2008/07),
FR6G0123 (Exp 2008/08), FR6H0193 (Exp 2008/08) and FR6H0201 (Exp
2008/08);
4) Lot Numbers: FR6G0124 (Exp 2008/08), FR6G0125 (Exp 2008/07) and
FR6H0181 (Exp 2008/08);
5) Lot Numbers: FR6G0126 (Exp 2008/07), FR6G0127 (Exp
2008/08) and FR6H0200 (Exp 2008/08);
6) Lot Number: FR6G0129;
7) Lot
Number: FR6G0131;
8) Lot Number: FR6G0132;
9) Lot Number: FR6GG0133;
10) Lot Numbers: FR6G0134 (Exp 2008/08), FR6H0179 (Exp 2008/08) and FR6H0197
(Exp 2008/08);
11) Lot Number: FR6H0173 (Exp 2008/08);
12) Lot Numbers:
FR6H0139 (Exp 2008/08) and FR6H0199 (Exp 2008/08);
13) Lot Number: FR6H0140;
14) Lot Number: FR6H0141;
15) Lot Number: FR6H0142;
16) Lot Number:
FR6H0150 ;
17) Lot Number: FR6H0151;
18) Lot Number: FR6H0152;
19)
Lot Number: FR6H0153;
20) Lot Number: FR6H0154;
21) Lot Number:
FR6H0155;
22) Lot Number: FR6H0156;
23) Lot Number: FR6H0157;
24) Lot
Number: FR6H0158;
25) Lot Number: FR6H0159;
26) Lot Number:
FR6H0160;
27) Lot Number: FR6H0161;
28) Lot Number: FR6H0162;
29) Lot
Number: FR6H0163;
30) Lot Number: FR6H0164;
31) Lot Number:
FR6H0165;
32) Lot Number: FR6H0166;
33) Lot Number: FR6H0167;
34) Lot
Number: FR6H0168;
35) Lot Number: FR6H0169;
36) Lot Number:
FR6H0170;
37) Lot Number: FR6H0172;
38) Lot Number: FR6H0174;
39) Lot
Number: FR6H0175;
40) Lot Number: FR6H0176;
41) Lot Number:
FR6H0178;
42) Lot Number: FR6H0184;
43) Lot Number: FR6H0185;
44) Lot
Number: FR6H0186;
45) Lot Number: FR6H0187;
46) Lot Number:
FR6H0188;
47) Lot Number: FR6H0189;
48) Lot Number: FR6H0190;
49) Lot
Number: FR6H0191;
50) Lot Numbers: FR6H0198;
51) Lot Number: FR6H0204,
RFR6H0206
RECALLING FIRM/MANUFACTURER Edwards
Lifesciences LLC, Irvine, CA,
REASON Incorrect Expiration Date:
Products were labeled with an incorrect shelf-life expiration date. Therefore,
the sterility of the device may be compromised.
VOLUME OF PRODUCT IN
COMMERCE 401
units
DISTRIBUTION Nationwide
PRODUCT Impax 4.5, Impax 5.0, Impax 5.2 and Impax 5.2x Picture Archiving Systems (PACs) with integrated Voxar 3D software; and Impax 5.0 and Impax 5.2 PACs with integrated MediCAD software. The softwares are used to provide digital X-ray images for pre-surgical orthopedic planning,
CODE
Hectec
MediCAD: ETSAN; VOXAR 3D: L72JO;
and Impax 4.5 or 5.0 or 5.2 Client /OT3000: A component of Order Codes:
60+00021533, 60+00021534, 60+00022471, 60+00022472, 60+00015451, 60+00015453,
60+00021535 and 60+00024519
RECALLING
FIRM/MANUFACTURER AGFA Corp., Greenville, SC,
REASON Misidentification: The orthopedic
planning X-ray images for one patient are misidentified as the images for
another patient.
VOLUME OF PRODUCT IN COMMERCE 879
units
DISTRIBUTION Nationwide and Canada
PRODUCT GentleTouch
System-Colostomy/Ileostomy Postoperative Kit; Ostomy pouch and
accessories; UPC Code Number: 30003-020938; 2 3/4 in., 70mm;
CODE
Lot Numbers: 7G29699, 7G30740, 7G31418,
7H22693, 7H24608, 7J30626, 7J32192 and 7K30871. Lot numbers 7L27391, 8A33519 and
8A37099 are also affected, however they have not been
distributed.
RECALLING FIRM/MANUFACTURER
Recalling
Firm: ConvaTec, Skillman, NJ,
Manufacturer: Convatec, A Bristol-Myers Squibb Co., Greensboro, NC.
REASON
Mislabeled: The carton label reads
"For post-surgical use following a urostomy procedure." It should read "For
post-surgical use following a colostomy or ileostomy procedure."
VOLUME OF
PRODUCT IN COMMERCE 9,299
units
DISTRIBUTION Nationwide and Internationally
WEEK ENDING JULY 26
PRODUCT BHM
Medical Infrared (IR) Hand Control System, an optional wireless control
component of the Arjo Maxi Sky 600 and BHM V4 Ceiling Patient Lifts; the hand
control system is composed of two components, part 700.13640.33 - IR hand
control, and part 492.00038 - IR receiver board,
CODE There are no serial numbers on the BHM
Medical Infrared (IR) Hand Control System, part 700.13640.33 - IR hand control,
and part 492.00038 - IR receiver board. The hand controls were installed on the
following ceiling lifts: i) Maxi Sky 600, part LD10111, serial numbers
LD-2605-15164, LD30733967, LD30733968, LD480627315, LD-5105-21404; ii) V4, part
9100021, serial numbers V4-1107-29534, V4-1307-29837, V4-3307-33778,
V4-1507-30147, V4-1905-14715, V4-4205-18404, V4-3606-26259, LD-1706-24108,
V4-0206-22026, V4-3405-16157, V4-4606-27188, V4-4803-04671, V4-1307-29838,
V4-1806-24149, V4-3307-33779, V4-4207-36144; part 9100021.13, serial numbers
V4-0805-09557, V4-1006-23261; part 9100023, serial number V4-1406-23773; and
part 9101021, serial number V4-0105-08044
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL,
Manufacturer: B. H. M. Medical, Inc.,
Magog,
Canada.
REASON The
ceiling lift may not stop lateral movement after releasing the left (or right)
action button on a ceiling lift equipped with an infrared hand
control.
VOLUME OF PRODUCT IN COMMERCE 25
units
DISTRIBUTION Nationwide
PRODUCT AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885.
Sterile Transvaginal Bladder Neck Support System,
CODE
Lot Numbers: 527059 and
527061
RECALLING FIRM/MANUFACTURER American Medical
Systems, Minnetonka, MN
REASON Missing part: The
units in two lots of In-Fast Ultra Transvaginal Bladder Neck Support System may
contain only one bone screw, but should contain two as indicated on the
labeling. Two screws are required to complete the procedure. The missing screw
will result in the inability to complete the procedure as expected if there are
no additional screws readily available.
VOLUME OF PRODUCT IN
COMMERCE 57
units
DISTRIBUTION Nationwide
PRODUCT Fabius GS Anesthesia Machine; Gas machine for anesthesia or
analgesia; Catalog Number: 8604700;
CODE
Serial Numbers: ARWM0008, ARWM0009,
ARWM0010, ARWM0011, ARWM0012, ARWM0013, ARWM0014, ARWM0015, ARWM0029, ARWM0030,
ARWM0031, ARWM0032, ARWM0033, ARWM0034, ARWM0035, ARWM0036, ARWM0037, ARWM0050,
ARWM0051, ARWM0052, ARWM0053, ARWM0057, ARWM0058, ARWM0059, ARWM0061, ARWM0062,
ARWM0063, ARWM0064, ARWM0065, ARWM0066, ARWM0067, ARWM0068, ARWM0069, ARWM0070,
ARWM0071, ARWM0072, ARWM0073, ARWM0074, ARWM0075, ARWM0076, ARWM0077, ARWM0078,
ARWM0079, ARWM0080, ARWM0081, ARWM0082, ARWM0083, ARWM0084, ARWM0085, ARWM0092,
ARWM0093, ARWM0097, ARWM0098, ARWM0099, ARWM0100, ARWM0101, ARWM0102, ARWM0103,
ARWM0104, ARWM0105, ARWM0108, ARWM0112, ARWM0113, ARWM0114, ARWM0115, ARWM0116,
ARWM0117, ARWM0118, ARWM0119, ARWM0120, ARWM0121, ARWM0122, ARWM0123, ARWM0124,
ARWM0125, ARWM0126, ARWM0127, ARWM0128, ARWM0129, ARWM0130, ARWM0131, ARWM0132,
ARWM0133, ARWM0134, ARWM0135, ARWM0136, ARWM0137, ARWM0138, ARWM0139, ARWM0140,
ARWM0157, ARWM0159, ARWM0160, ARWM0161, ARWM0162, ARWM0163, ARWM0164, ARWM0165,
ARWM0167, ARWM0168, ARWM0169, ARWM0170, ARWM0171, ARWM0172, ARWM0176, ARWM0177,
ARWM0178, ARWM0179, ARWM0180, ARWM0181, ARWM0184, ARWM0215, ARWM0216, ARWM0217,
ARWM0219, ARWM0224, ARWM0232, ARWM0284, ARWM0285, ARWM0286, ARWM0287, ARWM0288,
ARWM0289, ARWM0308, ARWM0309, ARWM0310, ARWM0311, ARWM0313, ARWM0314, ARWM0315,
ARWM0323, ARWM0326, ARWM0327, ARWM0328, ARWM0329, ARWM0330, ARWM0331, ARWM0333,
ARWM0335, ARWM0337, ARWN0001, ARWN0002, ARWN0003, ARWN0005, ARWN0014, ARWN0015,
ARWN0016, ARWN0017, ARWN0018, ARWN0019, ARWN0022, ARWN0023, ARWN0024, ARWN0025,
ARWN0026, ARWN0027, ARWN0028, ARWN0029, ARWN0030, ARWN0031, ARWN0033, ARWN0034,
ARWN0035, ARWN0036, ARWN0037, ARWN0038, ARWN0039, ARWN0040, ARWN0041, ARWN0042,
ARWN0043, ARWN0044, ARWN0045, ARWN0046, ARWN0058, ARWN0060, ARWN0061, ARWN0062,
ARWN0063, ARWN0064, ARWN0065, ARWN0066, ARWN0067, ARWN0076, ARWN0078, ARWN0080,
ARWN0081, ARWN0082, ARWN0083, ARWN0084, ARWN0085, ARWN0087, ARWN0088, ARWN0176,
ARWN0184, and ARWN0214
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Draeger Medical, Inc., Telford,
PA,
Manufacturer: Draeger Medical AG & Co, Lubeck, Germany.
REASON Detachment of Component: The chassis on some
machines were manufactured out of specifications. As a result, the caster may
break loose from the chassis.
VOLUME OF PRODUCT IN
COMMERCE 196
units
DISTRIBUTION Nationwide
PRODUCT
a) Smiths Medical FLO2 Emergency Non-rebreather High Flow O2
System; Positive end expiratory pressure breathing
attachment; Reference Number: P60000;
b) Smiths Medical
Oxy-PEEP High Flow O2 with PEEP; Positive end expiratory pressure breathing attachment; Reference Number: P63000;
CODE
a) Lot Numbers: 37L04D188 and
38A030257;
b) Lot Numbers: 38A30D064 and 38B09D021
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Smiths Medical ASD, Inc.,
Rockland, MA,
Manufacturer: Smiths Medical ASD, Inc., Dublin, OH.
REASON
Incorrect Oxygen
Level: Device may not provide expected oxygen concentration or the expected flow
rate due to incorrectly molded part. Patient will not receive proper amounts of
air/oxygen when in need.
VOLUME OF PRODUCT IN
COMMERCE 846 eaches
DISTRIBUTION Nationwide
and Canada
PRODUCT Celsus Laboratories Heparin Lithium Lyophilized; Lithium Heparin
for use in blood collection tube devices and in vitro diagnostic devices,
CODE
Lot #’s: HL-31707, HL-31807, HL-32708,
HL-32808 & HL-32908
RECALLING
FIRM/MANUFACTURER Celsus Laboratories, Inc., Cincinnati, OH,
REASON
Contamination: The firm learned that up
to 2.2% oversulfated chondroitin was found in a batch of crude heparin they
received from their supplier.
VOLUME OF PRODUCT IN
COMMERCE
HL-31707=11,542g, HL-31807=12,836g, HL-32708=8,374g,
HL-32808=12,128g &
HL-32908=5,000g
DISTRIBUTION Nationwide and
Internationally
PRODUCT Medtronic Intrathecal Catheter Pump Segment Revision Kit;
Programmable implanted infusion pump; Model number: 8596SC; Packaged with
catheter model number 8731 or 8731SC.
CODE
Lot Numbers: N131154001, N131154003,
N131154004, N131154008, N131154009, N131154010, N131154013, N131154016,
N131154017, N130483001, N130483004, N130483006, N130483011, N130483012,
N130483013, N130483014, N130483015 and N130483021
RECALLING
FIRM/MANUFACTURER Medtronic Neuromodulation, Minneapolis, MN
REASON
Incorrect Connector Pin: The Medtronic
8596SC Intrathecal Catheter Pump Segment Revision kits were packaged with the
incorrect connector pin.
VOLUME OF PRODUCT IN COMMERCE 18
units
DISTRIBUTION Nationwide
PRODUCT Vascular Drape, Surgical drape and drape accessories; Reference
Number: EF 00-902776-01; Packaged in a box of 10,
CODE
Lot Number:
172010207
RECALLING FIRM/MANUFACTURER
Recalling Firm: OEC
Medical Systems, Inc., Salt Lake City, UT,
Manufacturer: Contour Fabricators Inc., Fenton MI.
REASON
No Premarket Notification:
Product does not have FDA 510(k) approval for use.
VOLUME OF PRODUCT
IN COMMERCE 158
boxes
DISTRIBUTION Nationwide
PRODUCT Sequoia Spinal System Surgical Kits; Pedicle screw spinal system;
Non-sterile (kits intended to be sterilized prior to use); Rx Only; The Sequoia
Spinal System is designed to aid in the surgical correction of several types of
spinal conditions. The product is a system of smaller devices used to provide
stabilization during the development of a solid fusion mass,
CODE
Part Numbers: 3300-0001-PL and
3300-0002-PL
RECALLING FIRM/MANUFACTURER Abbott Spine,
Austin, TX,
REASON Screw
Head Dissociation: The polyaxial screw head may dissociate from screw shaft
during surgery. Also, the polyaxial screw driver is experiencing difficulty
(broken/bent driver shafts, difficulty attaching screws to the driver and
jamming of the collet.)
VOLUME OF PRODUCT IN COMMERCE 38
kits
DISTRIBUTION Nationwide
PRODUCT
a)
Scorpio Total Knee Cruciate Retraining Femoral Component; Knee joint
patellofemorotibial polymer/metal/polymer
semi-constrained cemented prosthesis; Product Number: 70-300-7R;
b) Scorpio Total Knee
Posteriorly Stabilized Femoral Component; Knee joint
patellofemorotibial
polymer/metal/polymer semi-constrained
cemented prosthesis; Product Number: 71-4507R;
CODE
a) Lot Number: K04W966;
b) Lot
Number: K04W718
RECALLING FIRM/MANUFACTURER Stryker
Howmedica Osteonics, Corp., Mahwah, NJ
REASON Mislabeled: The
labeling indicates a Scorpio PS Femoral Component, however, the device inside
the package is actually a Scorpio CR Femoral Component.
VOLUME OF
PRODUCT IN COMMERCE 12
units
DISTRIBUTION Nationwide and Internationally