Recall Z-0906-03 ยท CAC Apparatus, Autotransfusion
Fresenius Hemocare, Inc.
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.
| Date | Jun 5, 2003 (initiated Jan 21, 2003) |
| Status | Terminated |
| Reason | Sterility may be compromised |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012178 | FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW Fresenius Hemotechnology, Inc., Jul 23, 2001 |
| K960006 | C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM Fresenius AG, Jul 31, 1996 |
| K984233 | C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE Fresenius Hemotechnology, Inc., Feb 1, 1999 |