Vaccines, Blood & Biologics

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

SKUDescription
120-92BLOOD BAG CP2D/AS3 DBL 500 SP
121-93BLOOD BAG CP2D/AS3 TR500MLSP
121-94BLOOD BAG CP2D/AS3 QD500MLSP
123-93RC-PL TRIP CP2D/AS3 SDP
123-94RC-PL QUAD CP2D/AS3 SDP
125-93PL TRIP CP2D/AS3 500ML SDP
125-94PL QUAD CP2D/AS3 500ML SDP
126-92WBV DBL CP2D/AS3 500ML SDP
126-93WBV TRIP CP2D/AS3 500ML SDP
129-92RC2D DBL CP2D/AS-3 500ML SDP
129-93RC2D TRIP CP2D/AS3 500ML SDP
129-94RC2D QUAD CP2D/AS3 500 ML SDP
130-92BLOOD BAG CPDA-1 DBL 500 SP
136-92WBV DBL CPDA-1 500ML SDP
136-93WBV TRIP CPDA-1 500ML SDP
136-94WBV QUAD CPDA-1 500ML SDP
626-92VWB CP2D/AS3 DBL 500ML SDP
626-93VWB CP2D/AS3 TRIP 500ML SDP
629-93RC2D TRIP CP2D/AS3 500ML SDP
720-92BLOOD BAG CP2D/AS3 DBL 450 SP
SKUDescription
721-93BLOOD BG CP2D/AS3 TRP 450ML SP
722-92RC DBL CP2D/AS3 450ML SDP
723-93RC-PL TRIP CP2D/AS3 SDP
726-63VWB,CP2D/AS-3 TRIPLE 450ML SDP
726-63QVWB,CP2D/AS-3 TRIPLE 450ML SDP
726-92WBV DBL CP2D/AS3 450ML SDP
726-92RE02699WBV DBL CP2D/AS3 450ML SDP
726-93WBV TRIP CP2D/AS3 450ML SDP
730-92BLOOD BAG CPDA-1 DBL 450ML
736-92WB V DBL CPDA-1 450 ML SDP
736-94CDPA-1, 450 ML CAPACITY, QUAD
ATSBC1EBFILTSYSHELEUKO ATS BC PL BL LB
ATSBC1EPSLFILT SYS HELEUKOATSBCPLW/NDL L
ATSBC1ESBFILT SYS HELEUKOATSBCPLW/NDL B
ATSBC1ESNFILT SYS HELEUKOATSBCPLW/NDL N
ATSBC1EUFILTER SYSTEMLEUKOATSBCPLUK LB
ATSBCIESBFILT SYS HELEUKOATSBCPLW/NDL B
BCT0EUPRCBCT0EUPRC - TORNIER - EU
BPF4BWLFILT BLOODPROCSET BPF4 LEUKO L
C-PETFILTER HARVEST SET
NFB434CCLT&B QUAD CPD/SAG-M 450 ML
NFB434CCLRE2691T&B QUAD CPD/SAG-M 450 ML
RC2VAYEF PURECELLRC2F/BLOODW/YSETEULB
RCB434CCLT&T QUAD WB CPD/SAG-M 450ML
RCB434CCLT&T QUAD WB CPD/SAG-M 450ML
SKUDescription
RCB434CCLST&B QUAD RCS CPD/SAG-M 450 ML
RCB434CELRCT&B4PVCBAG63MLCPD/100MLSAG-M
RCB434CEL3RCT&B4PVCBAG63MLCPD/100MLSAG-M
RCB434CUPRCT&B4PVCBAGS63MLCPD/100ML SAG
RCB436CCURED CELL SYSTEM
RCB436CCURE2700T&B QUAD RC CPD/SAG-M 450 ML
RCB436CCURE2701T&B QUAD RC CPD/SAG-M 450 ML
RCB436CCURE2721T&B QUAD RC CPD/SAG-M 450 ML
RCB436CCURE2727T&B QUAD RC CPD/SAG-M 450 ML
RCB436CCURE2740T&B QUAD RC CPD/SAG-M 450 ML
RCB436CCURE2743T&B QUAD RC CPD/SAG-M 450 ML
RCB436CEU3RCT&B4PVCBAGS63MLCPD/100MLSAG
RCB436CU3RCT&B4PVCBAGS63MLCPD/100ML SAG
RCB436KCET&B QUAD RC CPD/SAG-M 475 ML
>RCB438DCGST&B QUAD RCS CPD/SAG-M 500 ML
RCB438DCGSR2750T&B QUAD RC CPD/SAG-M 500 ML
RCT434CCLT&T QUAD RC CPD/SAG-M 450ML
RCT434CELRCT&T4PVCBG63MLCPD/100MLSAG-M
RLB434GEBRC T&B 4 PVC BAGS PAGGS- M
RPT434CCLT&T QUAD RCPL CPD/SAG-M 450ML
RPT434CELRCT&T4PVCBAG63MLCPD/100M SAG-M
WBB424CGWBT&B4PVCBG63MLCPD/100ML SAG-M
WBB434CBWBT&B4PVCBG63MLCPD/100ML SAG-M
WBT244ABWB T&T 2 PVC BAGS 63ML CPDA-1
WBT254ABWB T&T 2 PVC BAGS 63ML CPDA-1
SKUDescription
WBT334ALWB T&T 3 PVC BAGS 63ML CPDA-1
WBT424DEGCPD/SAG-M 70/110ml
WBT428GGWBT&T4PVCBGCPD/PAGGS-M63/100ML
WBT434AMWB T&T 4 PVC BAGS 63ML CPDA-1
WBT434CCWBT&T4PVCBAGSCPD/SAG-M63/100ML
WBT434CCLT&T Quad WB CPD/SAG-M 450ML
WBT434CELWBT&T4PVCBAGSCPD/SAG-M63/100ML
WBT434CEU10.WBT&T4PVCBGCPD/SAG-M63100ML
WBT434CNWB T&T4PVCBAGSCPD/SAGM63/100ML
WBT434CUPWBT&T4PVCBAGSCPD/SAG-M63/100ML
WBT434GBWB T&T 4 BAGS / PAGGS- M
WBT434GEBWB T&T 4 BAGS / PAGGS- M
WBT434HGWBT&T4PVCBGCPD/PAGGS-M70/110ML
WBT436CCUT & T QUAD WB CPD/SAG-M 450ML
WBT436CEAWBT&T4PVCBAGSCPDSAGM63100ML
WBT436CEUWBT&T4PVCBAGSCPDSAGM63100ML
WBT436KCET&T QUAD WB CPD/SAG-M 475 ML
WBT438DCGT&T QUAD WB CPD/SAG-M 500 ML
WBT438DEGWBT&T4PVCBAG70MLCPD/110MLSAG-M
WBT438DGWBT&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.

Page Last Updated: 08/21/2014
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