FDA Medical Device Recalls (openFDA)
Cobe Cardiovascular, Inc: Custom heart lung perfusion packs
- Recall number
- Z-0265-06
- Recalling firm
- Cobe Cardiovascular, Inc
- Product
- Custom heart lung perfusion packs
- Status
- Terminated
- Initiated
- 2005-10-06
- Posted
- 2005-12-02
- Terminated
- 2011-08-05
- Reason
- One way valve in the heart lung pack assembly may be missing.
- Root cause
- Other
- Action
- Consignees notified by letter on 10/06/2005.
- Quantity
- 21,512 units
- Distribution
- Nation wide, including VA facilities in FL, NM, & CO and military facilities in CA, VA, & WA.
- Lot, serial or model codes
- 210 unique catalog numbers with 779 unique lot numbers.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- DTM
- 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