FDA Medical Device Recalls (openFDA)
Cryolife Inc: CryoValve, Pulmonary Valve & Conduit SG
- Recall number
- Z-0479-06
- Recalling firm
- Cryolife Inc
- Product
- CryoValve, Pulmonary Valve & Conduit SG
- Status
- Terminated
- Initiated
- 2004-05-06
- Posted
- 2006-02-04
- Terminated
- 2010-06-28
- Reason
- During a retrospective review, CryoLife identified positive microbiological culture results for donor tissues associated with various allografts.
- Root cause
- Other
- Action
- Consignees were notified by letter dated May 6, May 11, or May 12, 2004.
- Quantity
- 3 units
- Distribution
- FL, NC , NE, NV, NY, TN, TX, UT, WA, and Canada
- Lot, serial or model codes
- Donor #54782, Serial #7176836, Model #SGPV00* Donor #56853, Serial #7391356, Model #SGPV00* Donor #57296, Serial #7441881, 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