FDA Medical Device Recalls (openFDA)
Cryolife Inc: Heart-valve, allograft
- Recall number
- Z-1187-03
- Recalling firm
- Cryolife Inc
- Product
- Heart-valve, allograft
- Status
- Terminated
- Initiated
- 2003-02-04
- Posted
- 2003-08-28
- Terminated
- 2003-08-28
- Reason
- Donor of aortic valve had procurement cultures that were positive for E-coli.
- Root cause
- Other
- Action
- A CryoLife representative contacted the consignee by telephone on 2/4/2002 to inform her of the recall action. The graft was returned to CryoLife and destroyed on/about 2/11/2003.
- Quantity
- 1 unit
- Distribution
- Allograft was distrbuted to one medical facility in CA. No government or foreign accounts involved.
- Lot, serial or model codes
- Donor #60741, Model #SGAV10, Serial #783013
- 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