ATF 40 Fast Start Kit - contains one each AT1 Autotransfusion Set, ATS Suction Line, and the ATR40 Autotransfusion Reser
FDA device recall Z-0906-03 · posted 2003-06-05 · Terminated
Recall details
- Recalling firm
- Fresenius Hemocare, Inc.
- Reason for recall
- Sterility may be compromised
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- CAC
- Quantity affected
- 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, an
- Date initiated
- 2003-01-21
- Date posted
- 2003-06-05
- Date terminated
- 2003-06-04
- Location
- Redmond, WA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FRESENIUS C.A.T.S; ATI AUTOTRANSFUSION SET; PSQ PLASMA SEQUESTRATION SET; PSQ-DD PLASMA SEQUESTRATION DIRECT DRAW (K012178) | Fresenius Hemotechnology, Inc. | 2001-07-23 |
| C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINE (K984233) | Fresenius Hemotechnology, Inc. | 1999-02-01 |
| C.A.T.S. CONTINUOUS AUTOTRANSFUSION SYSTEM (K960006) | Fresenius AG | 1996-07-31 |