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U.S. Department of Health and Human Services

Enforcement Report - Week of April 17, 2013

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Product Detail

Product Description Leukotrap Blood Collection Systems with Flexible Y Connector, labeled as being manufactured by Medsep Corporation, A Subsidiary of Pall Corporation
Recall Number B-1063-13
Classification Class II
Code Info 12092 BLOOD BAG CP2D/AS3 DBL 500 SP; 12193 BLOOD BAG CP2D/AS3 TR500MLSP; 12194 BLOOD BAG CP2D/AS3 QD500MLSP; 12393 RC-PL TRIP CP2D/AS3 SDP; 12394 RC-PL QUAD CP2D/AS3 SDP; 12593 PL TRIP CP2D/AS3 500ML SDP; 12594 PL QUAD CP2D/AS3 500ML SDP; 12692 WBV DBL CP2D/AS3 500ML SDP; 12693 WBV TRIP CP2D/AS3 500ML SDP; 12992 RC2D DBL CP2D/AS-3 500ML SDP; 12993 RC2D TRIP CP2D/AS3 500ML SDP; 12994 RC2D QUAD CP2D/AS3 500 ML SDP; 13092 BLOOD BAG CPDA-1 DBL 500 SP; 13692 WBV DBL CPDA-1 500ML SDP; 13693 WBV TRIP CPDA-1 500ML SDP; 13694 WBV QUAD CPDA-1 500ML SDP; 62692 VWB CP2D/AS3 DBL 500ML SDP; 62693 VWB CP2D/AS3 TRIP 500ML SDP; 62993 RC2D TRIP CP2D/AS3 500ML SDP; 72092 BLOOD BAG CP2D/AS3 DBL 450 SP; 72193 BLOOD BG CP2D/AS3 TRP 450ML SP; 72292 RC DBL CP2D/AS3 450ML SDP; 72393 RC-PL TRIP CP2D/AS3 SDP; 72663 VWB,CP2D/AS-3 TRIPLE 450ML SDP; 72663 QVWB,CP2D/AS-3 TRIPLE 450ML SDP; 72692 WBV DBL CP2D/AS3 450ML SDP; 72692 RE02699 WBV DBL CP2D/AS3 450ML SDP; 72693 WBV TRIP CP2D/AS3 450ML SDP; 73092 BLOOD BAG CPDA-1 DBL 450ML; 73692 WB V DBL CPDA-1 450 ML SDP; 73694 CDPA-1, 450 ML CAPACITY, QUAD; ATSBC1EB FILTSYSHELEUKO ATS BC PL BL LB; ATSBC1EPSL FILT SYS HELEUKOATSBCPLW/NDL L; ATSBC1ESB FILT SYS HELEUKOATSBCPLW/NDL B; ATSBC1ESN FILT SYS HELEUKOATSBCPLW/NDL N; ATSBC1EU FILTER SYSTEMLEUKOATSBCPLUK LB; ATSBCIESB FILT SYS HELEUKOATSBCPLW/NDL B; BCT0EUPRC BCT0EUPRC - TORNIER EU; BPF4BWL FILT BLOODPROCSET BPF4 LEUKO L; C-PET FILTER HARVEST SET; NFB434CCL T&B QUAD CPD/SAG-M 450 ML; NFB434CCLRE2691 T&B QUAD CPD/SAG-M 450 ML; RC2VAYE F PURECELLRC2F/BLOODW/YSETEULB; RCB434CCL T&T QUAD WB CPD/SAG-M 450ML; RCB434CCL T&T QUAD WB CPD/SAG-M 450ML; RCB434CCLS T&B QUAD RCS CPD/SAG-M 450 ML; RCB434CEL RCT&B4PVCBAG63MLCPD/100MLSAG-M; RCB434CEL3 RCT&B4PVCBAG63MLCPD/100MLSAG-M; RCB434CUP RCT& B4PVCBAGS63MLCPD/100ML SAG; RCB436CCU RED CELL SYSTEM; RCB436CCURE2700 T&B QUAD RC CPD/SAG-M 450 ML; RCB436CCURE2701 T&B QUAD RC CPD/SAG-M 450 ML; RCB436CCURE2721 T&B QUAD RC CPD/SAG-M 450 ML; RCB436CCURE2727 T&B QUAD RC CPD/SAG-M 450 ML; RCB436CCURE2740 T&B QUAD RC CPD/SAG-M 450 ML; RCB436CCURE2743 T&B QUAD RC CPD/SAG-M 450 ML; RCB436CEU3 RCT& B4PVCBAGS63MLCPD/100MLSAG; RCB436CU3 RCT& B4PVCBAGS63MLCPD/100ML SAG; RCB436KCE T&B QUAD RC CPD/SAG-M 475 ML; RCB438DCGS T&B QUAD RCS CPD/SAG-M 500 ML; RCB438DCGSR2750 T&B QUAD RC CPD/SAG-M 500 ML; RCT434CCL T&T QUAD RC CPD/SAG-M 450ML; RCT434CEL RCT& T4PVCBG63MLCPD/100MLSAG-M; RLB434GEB RC T&B 4 PVC BAGS PAGGS- M; RPT434CCL T&T QUAD RCPL CPD/SAG-M 450ML; RPT434CEL RCT& T4PVCBAG63MLCPD/100M SAG-M; WBB424CG WBT& B4PVCBG63MLCPD/100ML SAG-M; WBB434CB WBT&B4PVCBG63MLCPD/100ML SAG-M; WBT244AB WB T&T 2 PVC BAGS 63ML CPDA-1; WBT254AB WB T&T 2 PVC BAGS 63ML CPDA-1; WBT334AL WB T&T 3 PVC BAGS 63ML CPDA-1; WBT424DEG CPD/SAG-M 70/110ml; WBT428GG WBT& T4PVCBGCPD/PAGGS-M63/100ML; WBT434AM WB T&T 4 PVC BAGS 63ML CPDA-1; WBT434CC WBT&T4PVCBAGSCPD/SAG-M63/100ML; WBT434CCL T&T Quad WB CPD/SAG-M 450ML; WBT434CEL WBT&T4PVCBAGSCPD/SAG-M63/100ML; WBT434CEU 10.WBT&T4PVCBGCPD/SAG-M63100ML; BT434CN WB T& T4PVCBAGSCPD/SAGM63/100ML; WBT434CUP WBT& T4PVCBAGSCPD/SAG-M63/100ML; WBT434GB WB TT 4 BAGS / PAGGS- M; WBT434GEB WB T&T 4 BAGS / PAGGS- M; WBT434HG WBT&T4PVCBGCPD/PAGGS-M70/110ML; WBT436CCU T & T QUAD WB CPD/SAG-M 450ML; WBT436CEA WBT& T4PVCBAGSCPDSAGM63100ML; WBT436CEU WBT& T4PVCBAGSCPDSAGM63100ML; WBT436KCE T&T QUAD WB CPD/SAG-M 475 ML; WBT438DCG T&T QUAD WB CPD/SAG-M 500 ML; WBT438DEG WBT&T4PVCBAG70MLCPD/110MLSAG-M; WBT438DG WBT&T4PVCBAG70MLCPD/110MLSAG-M
Product Distributed Qty 90
Reason For Recall Whole Blood Collection Sets, with a potential for a leak to occur in the flexible Y connector of the donor line, were distributed.

Event Detail

Event Id 63911
Product Type Biologics
Status Ongoing
Recalling Firm Haemonetics Corporation
City Braintree
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-12-06
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico
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