FDA Home Page | CBER A-Z Index | CBER Search | Contact CBER | CBER Home Page

DATE RECALL INITIATED: January 24, 2005 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.

Updated April 13, 2005

CBER Home Page | CBER A-Z Index | CBER Search | Contact CBER FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | Privacy | Accessibility | HHS Home Page FDA / Center for Biologics Evaluation and Research