Z-0906-03

ATF 40 Fast Start Kit - contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40...

Name: Z-0906-03 ATF 40 Fast Start Kit - contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40...
Creator: Fresenius Hemocare, Inc.
Published: 2003-01-21
License: https://open.fda.gov/license/

Fresenius Hemocare GmbH / initiated 2003-01-21 / Terminated / root cause: sterility

FDA source

Fresenius Hemocare, Inc. began a recall of 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... on 2003-01-21. The reason FDA records is "Sterility may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0906-03
Status: Terminated
Initiated: 2003-01-21
Posted: 2003-06-05
Terminated: 2003-06-04
Recalling firm: Fresenius Hemocare GmbH
Product: 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.
Product code: CAC Apparatus, Autotransfusion
Reason for recall: Sterility may be compromised
Root cause tag: sterility
FDA root cause: Other
Action: 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.
Quantity in commerce: ATF40 - 1264 (648 of AT1 suspect batch NHT272 were used, the remainder were of different batches)
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.
Product codes and lots: ATF 40 Fast Start Kit - Catalog no. 9108491, batch no. NKT257 AT1: Catalog no. 9005101, lot no. NHT272

Product code CAC

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)