FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-0906-03
- Recalling firm
- Fresenius Hemocare, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2003-01-21
- Posted
- 2003-06-05
- Terminated
- 2003-06-04
- 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.
- Lot, serial or model codes
- ATF 40 Fast Start Kit - Catalog no. 9108491, batch no. NKT257 AT1: Catalog no. 9005101, lot no. NHT272
- 510(k) numbers
- ["K960006","K984233","K012178"]
- PMA numbers
- not on file
- Product code
- CAC
- Firm FEI
- 3002987955
- Firm city
- Redmond
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28