FDA Medical Device Recalls (openFDA)
Cobe Cardiovascular, Inc: Cobe CML Duo Flat Sheet Membrane Oxygenator/Reservoir, sterile, (Standalone systems). Catalog Numbers: 050226400, 050422400. COBE Cardiovascular, Inc..
- Recall number
- Z-1423-06
- Recalling firm
- Cobe Cardiovascular, Inc
- Product
- Cobe CML Duo Flat Sheet Membrane Oxygenator/Reservoir, sterile, (Standalone systems). Catalog Numbers: 050226400, 050422400. COBE Cardiovascular, Inc..
- Status
- Terminated
- Initiated
- 2006-06-26
- Posted
- 2006-08-24
- Terminated
- 2011-08-08
- Reason
- Cooling and rewarming time is extended. Efficiency of the heat exchangers is reduced because many of the folds that are critical to heat exchange on the blood side of the units were blocked with a metalic material, thus decreasing the surface area needed for proper heat transfer.
- Root cause
- Other
- Action
- Consignees were notified by letter on 06/26/2006.
- Quantity
- 474 units (Domestic)
- Distribution
- Worldwide distribution --- USA including VA facilities in CO, GA, MO and countries of Australia, Canada, Italy, and Japan
- Lot, serial or model codes
- Catalog # 050226400, Lot Numbers: 0607300026, 0609400146, 0610100183, 0611600089, 0612200155, 0612900044. ...Catalog # 050422400, Lot Numbers: 0607300025, 0608000018, 0608700122, 0610800088.
- 510(k) numbers
- ["K000255","K963518"]
- PMA numbers
- not on file
- Product code
- DTZ
- 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