FDA Medical Device Recalls (openFDA)
Cobe Cardiovascular, Inc: Cobe STAT PAC, Autotransfusion Set (Made with Compact Wash Sets), Cobe Product Codes: AS4C12, AS4C22, ASCBC12C, ASCBC22C, ASCBFC22C. Cobe Cardiovascular Inc.
- Recall number
- Z-1490-06
- Recalling firm
- Cobe Cardiovascular, Inc
- Product
- Cobe STAT PAC, Autotransfusion Set (Made with Compact Wash Sets), Cobe Product Codes: AS4C12, AS4C22, ASCBC12C, ASCBC22C, ASCBFC22C. 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-AS4C12, Lot numbers: 0611600045, 0615000020, 0616400010, 0617800124, 0618600111, 0619200113, 0620600004-COBE Product Code- AS4C22, Lot Numbers: 0611600044, 0615000019, 0616400009, 0619200112, 0620600003, 0621300089-COBE Product Code- ASCBC12C, Lot Numbers: 0615700004, 0618600106, 0621300091-COBE Product Code-ASCBC22C, Lot Numbers: 0614300112, 0617100072, 0617800125, 0619200114, 0620600005- COBE Product Code-ASCBFC22C, Lot Numbers: 0611600046, 0613000074, 0613600144, 0615000021, 0615700003, 0617100073, 0617800126, 0619200115, 0619900050, 0620600006.
- 510(k) numbers
- ["K982650"]
- 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