FDA Medical Device Recalls (openFDA)
Cobe Cardiovascular, Inc: Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55, AS9E22, AS9E12, AS4E55, AS4E22, AS4E17. Cobe Cardiovascular Inc.
- Recall number
- Z-1491-06
- Recalling firm
- Cobe Cardiovascular, Inc
- Product
- Cobe STAT PAC Autotransfusion Set (made with Electa Wash Set), Cobe Product Codes: ASCBFE22, ASCBE22, AS9E55, AS9E22, AS9E12, AS4E55, AS4E22, AS4E17. Cobe Cardiovascular Inc.
- Status
- Terminated
- Initiated
- 2006-08-04
- Posted
- 2006-09-09
- Terminated
- 2011-12-28
- Reason
- Foreign particles-manufacturing error may lead to abrasion of bowl seal in blood recovery sets, possibly causing particles in the blood.
- Root cause
- Other
- Action
- Consignees were notified by telephone and e-mail on 08/04/2006.
- Quantity
- 8,964 wash sets, 1,518 Stat pacs-Recalls Z-1488-1491-06
- Distribution
- Nationwide, including VA facilities in CA and OH
- Lot, serial or model codes
- COBE Product Code-ASCBFE22, Lot numbers: 0610100225, 0613000077, 0615700007, 0618600109, 0621300094-- COBE Product Code-ASCBE22, Lot Numbers: 0608000247, 0610800007, 0612300036, 0613000076, 0613600146, 0615700006, 0617200003, 0617800128, 0619200116, 0619900053, 0621300093--COBE Product Code- AS9E55, Lot Numbers: 0617200004, 0619900054, 0621300095-COBE Product Code- AS9E22, Lot Numbers: 0611600047, 0612300034, 0613000075, 0614300116, 0617200002, 0617800127, 0618600107, 0621300092--COBE Product Code- AS9E12, Lot Numbers: 0612300035, 0615000022, 0616400011, 0618600108, 0619900052-COBE Product Code- AS4E55, Lot Numbers: 0616400012, 0618600110- COBE Product Code-AS4E22, Lot Numbers: 0609400006, 0610100223, 0615700005, 0619900051-COBE Product Code- AS4E17, Lot Numbers: 0613600145, 0616400013, 0617200005, 0619900055.
- 510(k) numbers
- ["K020647"]
- PMA numbers
- not on file
- Product code
- CAC
- Firm FEI
- 1718850
- Firm city
- Arvada
- Firm state
- CO
- 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