DATE RECALL INITIATED:
PRODUCT NAME: |
PRODUCT NUMBER |
Neonatal Pediatric Aliquot System |
T2008
T2182
T2183
T2186
T2188
T3000
T3001
T3002
T3003
T3007
T3605
T3607 |
Neonatal/Pediatric Syringe Set |
03-960-32
03-960-33
03-960-34
03-960-57 |
Blood Administration Set |
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 |
Plasma / Fluid Transfer Set |
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 |
Pooling Harness Set |
T3006
T3194
T3198
T3199
T4004
T4006
T6010
T8004
T6006
T8005
T8006
T8010
T9006 |
Blood Transfer Bag |
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 |
Blood Freezing Bag |
T3400
T3401
T8703
T8703H |
Stem Cell Freezing Bag |
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
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
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