FDA Medical Device Recalls (openFDA)
Cryolife Inc: CryoValve Pulmonary Valve & Conduit.
- Recall number
- Z-0938-03
- Recalling firm
- Cryolife Inc
- Product
- CryoValve Pulmonary Valve & Conduit.
- Status
- Terminated
- Initiated
- 2003-05-23
- Posted
- 2003-06-17
- Terminated
- 2003-12-10
- Reason
- Microorganisms detected in associated allografts.
- Root cause
- Other
- Action
- The medical facility was notified by letter on May 23, 2003. The implanting physician was notified by letter on May 28, 2003.
- Quantity
- 2 individual heart valve allografts.
- Distribution
- The tissues were distributed to one medical facility in CT and to one physician in MT.
- Lot, serial or model codes
- Donor #64108, Serial #7984345, Model #PV00 and Donor #55416, Serial #7253418, Model #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