FDA Medical Device Recalls (openFDA)
Cryolife Inc: CryoValve, Alt Pulmonary Valve & Conduit
- Recall number
- Z-0212-06
- Recalling firm
- Cryolife Inc
- Product
- CryoValve, Alt Pulmonary Valve & Conduit
- Status
- Terminated
- Initiated
- 2003-11-19
- Posted
- 2005-11-30
- Terminated
- 2009-07-02
- Reason
- Previously released tissues no longer meet CryoLife's enhanced suitability release criteria because donors possessed a positive post processing microbiological culture of 'potentially pathogenic' organisms.
- Root cause
- Other
- Action
- Consignees were notified by letter starting 11/17/2003.
- Quantity
- 3 units
- Distribution
- AR, AZ, CA, CT, DC, FL, IL, LA, MN, NC, NH, NV, NY, TN, TX, UT, and Germany.
- Lot, serial or model codes
- Donor #28776, Serial #6162886, Model #PV05, Donor #29275, Serial #6180566, Model #PV05, Donor #30815, Serial #6235387, Model #PV05
- 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