FDA Medical Device Recalls (openFDA)
Cryolife Inc: CryoValve Allograft, Heart valve
- Recall number
- Z-0866-03
- Recalling firm
- Cryolife Inc
- Product
- CryoValve Allograft, Heart valve
- Status
- Terminated
- Initiated
- 2003-04-30
- Posted
- 2003-05-22
- Terminated
- 2004-04-29
- Reason
- Microorganisms were detected in associated allografts.
- Root cause
- Other
- Action
- Implanting physicians were notified via letter on April 30, 2003. They were advised to quarantine and return the allograft if not implanted. A self addressed, stamped postcard was included to affirm receipt of the notice and to provide information of final disposition of the allograft.
- Quantity
- 8 units
- Distribution
- The components were distributed to hospitals and physicians located in CA, IL IN, , NM, OH and OK.
- Lot, serial or model codes
- Donor #61838, Serial #7691913, Model #SGPV00; Donor #65235, Serial #7915089, Model #SGAV00, Donor #64922, Serial #7883079, Model #SGAV00; Donor #64779, Serial #7883080, Model #SGPV00; Donor #64779 77888910, Model #SGPV00; Donor #64779, Serial #7888909, Model #SGAV00; and Donor #63941, Serial #7894710, Model #SGPV00.
- 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