FDA Device

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.

Hazard

Sterility may be compromised

What You Should Do

Remedy

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.

Products

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 Autotransfusi
Brand
Fresenius Hemocare, Inc.
UPC
ATF 40 Fast Start Kit -  Catalog no. 9108491, batch no. NKT257  AT1: Catalog no. 9005101, lot no. NHT272

Units Affected

ATF40 - 1264 (648 of AT1 suspect batch NHT272 were used, the remainder were of different batches)