ATF 40 Fast Start Kit - contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40 Autotransfusion Reservoir. The component that is the subject of the recall is the AT1 Autotransfusion Set.
- Company
- Fresenius Hemocare, Inc.
- Recall Initiated
- January 21, 2003
- Posted
- June 5, 2003
- Terminated
- June 4, 2003
- Recall Number
- Z-0906-03
- Quantity
- ATF40 - 1264 (648 of AT1 suspect batch NHT272 were used, the remainder were of different batches)
- Firm Location
- Redmond, WA
Reason for Recall
Sterility may be compromised
Distribution
All ATF 40 kits were distributed to one distributor located in MI. The distributor in turn distributed product to 21 hospitals and medical centers in AL, FL, NE, KS, MI, NE, NJ, NY, OH, PA, TX, VA, and WA.
Lot / Code Info
ATF 40 Fast Start Kit - Catalog no. 9108491, batch no. NKT257 AT1: Catalog no. 9005101, lot no. NHT272
Root Cause
Other
Action Taken
On 1/21/03 the firm notified, via telephone, the distributor of the product. The distributor was advised to return any unused product and to contact their customers for return of product. This was followed by a letter 1/21/03 sent via e-mail. The distributor in turn contacted their customers on 1/23/03 by telephone. This was followed by a letter dated 1/23/03.
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