FDA Medical Device Recalls (openFDA)
Cobe Cardiovascular, Inc: Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt
- Recall number
- Z-1009-04
- Recalling firm
- Cobe Cardiovascular, Inc
- Product
- Cardioplegia Pack BCD Vanguard Ratio 4:1 with Shunt
- Status
- Terminated
- Initiated
- 2004-05-25
- Posted
- 2004-07-20
- Terminated
- 2005-03-31
- Reason
- Some Cardioplegia Delivery Sets, 4:1 w/shunt, were misassembled with 1:1 tubing sub-assemblies. This would provide 2 1/2x the desired cardioplegia.
- Root cause
- Other
- Action
- Customers were notified by telephone on 5/25/2004 and by letter on 6/3/2004.
- Quantity
- 216 sets
- Distribution
- AL, AZ, FL, KS, MN, MO, NV, TX, WI. Foreign distribution to Canada.
- Lot, serial or model codes
- Catalog # 027770201, Lot # 0406800015.
- 510(k) numbers
- ["K934847"]
- PMA numbers
- not on file
- Product code
- DTN
- 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