FDA Medical Device Recalls (openFDA)
Cryolife Inc: CryoValve, Aortic Valve & Conduit SG
- Recall number
- Z-0172-05
- Recalling firm
- Cryolife Inc
- Product
- CryoValve, Aortic Valve & Conduit SG
- Status
- Terminated
- Initiated
- 2004-05-06
- Posted
- 2004-11-03
- Terminated
- 2010-06-29
- Reason
- CryoLife conducted a retrospective review which revealed the sterilization cycle of instruments used during processing of various tissues could not be confirmed as acceptable.
- Root cause
- Other
- Action
- Consignees were notified by letter on/about May 6, 2004.
- Quantity
- 4 units
- Distribution
- Nationwide, Austria, Canada, Germany
- Lot, serial or model codes
- Donor #60727, Serial #7763406, Model #SGAV00* Donor #62532, Serial #7818159, Model #SGAV00* Donor #64863, Serial #7865603, Model #SGAV00* Donor #65932, Serial #8105091, Model #SGAV00
- 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
- 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