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.
FDA Recall Z-0906-03 · Posted 2003-06-05
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Recalling FirmFresenius Hemocare, Inc.
Recall StatusTerminated
Product CodeCAC
Date Initiated2003-01-21
Date Terminated2003-06-04
Product QuantityATF40 - 1264 (648 of AT1 suspect batch NHT272 were used, the remainder were of different batches)
Reason for Recall
Sterility may be compromised
Firm 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.
Root Cause
Other
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K012178FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAWFresenius Hemotechnology, Inc. · 2001-07-23K984233C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINEFresenius Hemotechnology, Inc. · 1999-02-01K960006C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEMFresenius AG · 1996-07-31
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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