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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Blood Bank Devices-Charter Medical, Ltd.

DATE RECALL INITIATED:

 

January 24, 2005

 

PRODUCT NAME: Neonatal Pediatric Aliquot System 

 

PRODUCT NUMBER:


T2008
T2182
T2183
T2186
T2188
T3000
T3001
T3002
T3003
T3007
T3605
T3607


PRODUCT NAME: Neonatal/Pediatric Syringe Set 

 

PRODUCT NUMBER:

 

03-960-32
03-960-33
03-960-34
03-960-57


PRODUCT NAME:  Blood Administration Set 

 

PRODUCT NUMBER:

 

03-110-01
03-110-65
03-110-85
03-111-02
03-111-03
03-118-01
03-122-00
03-122-10
03-202-13


PRODUCT NAME: Plasma / Fluid Transfer Set 

 

PRODUCT NUMBER:

 

03-220-00
03-220-01
03-220-10
03-220-30
03-220-31
03-220-50
03-220-90
03-220-91
03-220-92
03-220-94
03-220-95
03-220-99
03-220-ACP
 

PRODUCT NAME: Pooling Harness Set 

 

PRODUCT NUMBER:

 

T3006
T3194
T3198
T3199
T4004
T4006
T6010
T8004
T6006
T8005
T8006
T8010
T9006

 

PRODUCT NAME: Blood Transfer Bag 

 

PRODUCT NUMBER:

 

T3101
T3104
T3106
T3107
T3108
T3109
T3135
T3137
T3160
T3196
T3972
T3992
T3103
T3106X2
T3108SL
T9700
BT1000
BT300
BT600
C600
C605
C1000-QD
C605SWL
CBC-400


PRODUCT NAME: Blood Freezing Bag 

 

PRODUCT NUMBER:

 

T3400
T3401
T8703
T8703H

 

PRODUCT NAME:  Stem Cell Freezing Bag 

 

PRODUCT NUMBER:

 

LN025S01
LN060S01
LN060T02
LN075S01

MANUFACTURER:

Charter Medical, Ltd
Winston-Salem, North Carolina

 

REASON:

Charter Medical, Ltd. has initiated a voluntary recall of ethylene oxide (EtO) sterilized Class II devices manufactured since January 1, 2001. The sterility of these devices may be compromised due to an inadequate validation of the sterilization cycle. Consignees have been asked to return any affected product to the manufacturer.

 

Additional products recalled 3/30/2005

 

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448