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.
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