FDA Medical Device Recalls (openFDA)
Cryolife Inc: CryoValve, Pulmonary Valve & Conduit
- Recall number
- Z-1297-03
- Recalling firm
- Cryolife Inc
- Product
- CryoValve, Pulmonary Valve & Conduit
- Status
- Terminated
- Initiated
- 2003-09-10
- Posted
- 2003-10-15
- Terminated
- 2004-05-06
- Reason
- Firm received additional information from the procurement agency indicating that the donor's serological test sample may have been sufficiently diluted by transfusion/infusion to invalidate the HIV and Hepatitis B and C screening test results.
- Root cause
- Other
- Action
- Consignees were notified by letter on 09/10/2003 and 09/12/2003.
- Quantity
- 1 unit
- Distribution
- The tissues were distributed to one hospital in CA and one physician in MN.
- Lot, serial or model codes
- Donor #69884, Serial #8062341, Model #PV00.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NJK
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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