FDA Medical Device Recalls (openFDA)
Cryolife Inc: CryoValve, Pulmonary Valve & Conduit
- Recall number
- Z-0026-05
- Recalling firm
- Cryolife Inc
- Product
- CryoValve, Pulmonary Valve & Conduit
- Status
- Terminated
- Initiated
- 2004-07-15
- Posted
- 2004-10-20
- Terminated
- 2007-12-31
- Reason
- A pre-implant swab culture of the aortic valve, which was procured from the same donor, was positive for Methicillin resistant Staphyococcus aureus.
- Root cause
- Other
- Action
- The physician was notified by letter on 07/15/2004.
- Quantity
- 1 tissue
- Distribution
- The tissue was shipped to one physician in CA.
- Lot, serial or model codes
- Donor Number: 68668, Serial Number: 8037696, Model Number: PV00
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MIE
- Firm FEI
- 3001451326
- Firm city
- Kennesaw
- Firm state
- GA
- 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