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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Haemonetics Field Action - All lots of Whole Blood Collection Sets Identified by the Product Codes listed herein

 


 

DATE NOTIFICATION INITIATED: December 6, 2012
 
PRODUCT CODES
 
SKU
Description
120-92
BLOOD BAG CP2D/AS3 DBL 500 SP
121-93
BLOOD BAG CP2D/AS3 TR500MLSP
121-94
BLOOD BAG CP2D/AS3 QD500MLSP
123-93
RC-PL TRIP CP2D/AS3 SDP
123-94
RC-PL QUAD CP2D/AS3 SDP
125-93
PL TRIP CP2D/AS3 500ML SDP
125-94
PL QUAD CP2D/AS3 500ML SDP
126-92
WBV DBL CP2D/AS3 500ML SDP
126-93
WBV TRIP CP2D/AS3 500ML SDP
129-92
RC2D DBL CP2D/AS-3 500ML SDP
129-93
RC2D TRIP CP2D/AS3 500ML SDP
129-94
RC2D QUAD CP2D/AS3 500 ML SDP
130-92
BLOOD BAG CPDA-1 DBL 500 SP
136-92
WBV DBL CPDA-1 500ML SDP
136-93
WBV TRIP CPDA-1 500ML SDP
136-94
WBV QUAD CPDA-1 500ML SDP
626-92
VWB CP2D/AS3 DBL 500ML SDP
626-93
VWB CP2D/AS3 TRIP 500ML SDP
629-93
RC2D TRIP CP2D/AS3 500ML SDP
720-92
BLOOD BAG CP2D/AS3 DBL 450 SP

 

 
SKU
Description
721-93
BLOOD BG CP2D/AS3 TRP 450ML SP
722-92
RC DBL CP2D/AS3 450ML SDP
723-93
RC-PL TRIP CP2D/AS3 SDP
726-63
VWB,CP2D/AS-3 TRIPLE 450ML SDP
726-63Q
VWB,CP2D/AS-3 TRIPLE 450ML SDP
726-92
WBV DBL CP2D/AS3 450ML SDP
726-92RE02699
WBV DBL CP2D/AS3 450ML SDP
726-93
WBV TRIP CP2D/AS3 450ML SDP
730-92
BLOOD BAG CPDA-1 DBL 450ML
736-92
WB V DBL CPDA-1 450 ML SDP
736-94
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

 
 
SKU
Description
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

 

SKU
Description
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
WBT434CN
WB T&T4PVCBAGSCPD/SAGM63/100ML
WBT434CUP
WBT&T4PVCBAGSCPD/SAG-M63/100ML
WBT434GB
WB T&T 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

 
 
MANUFACTURER:
 
Haemonetics
Braintree, MA
 
REASON:
 
The purpose of this letter is to inform customers that there is the potential for a leak to occur, at a very low frequency, in the flexible Y connector of the donor line in some Whole Blood Collection Sets. Haemonetics has determined that all product lots for the product codes identified above require examination. 
Note: Because of the recent acquisition from Pall Corporation, all of these lots are labeled as being manufactured by Medsep Corporation, A Subsidiary of Pall Corporation.
 
Haemonetics is requesting that during the pre-phlebotomy and post-phlebotomy examination of the collection sets listed above, customers especially examine the Y connectors. If a defect is detected before collection, the set must be discarded. If a defect is detected during collection, the collection must be halted and any collected blood must be discarded, and if a defect is detected after collection, the blood must be discarded. Customers are asked to please report any defects to us immediately via fax at (626)-859-8139 or by email at QABlood@Haemonetics.com using the attached form.