FDA Medical Device Recalls (openFDA)
Cryolife Inc: Aortic Valve & Conduit
- Recall number
- Z-0859-05
- Recalling firm
- Cryolife Inc
- Product
- Aortic Valve & Conduit
- Status
- Terminated
- Initiated
- 2005-05-17
- Posted
- 2005-06-01
- Terminated
- 2005-06-01
- Reason
- Subsequent to tissue release, CryoLife received new information related to the donor time of death, which caused the donor to no longer meet CryoLife's acceptance criteria for warm ischemic time.
- Root cause
- Other
- Action
- Consignees were notified by telephone on May 17, 2005. Both tissues were returned and destroyed.
- Quantity
- 1 unit
- Distribution
- IL, MT
- Lot, serial or model codes
- Donor #77647, Serial #8461379, Model #AV00
- 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