CryoValve, Aortic Valve & Conduit
FDA device recall Z-0776-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- Microorganisms were detected in donor tissue associated with this allograft, specifically Aeormonas hydrophila.
- Action taken
- Consignee was notified first by telephone on 02/20/2004, then with follow up letter on 04/02/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 unit
- Distribution
- This tissue was distributed to one physician in CA.
- Date initiated
- 2004-02-20
- Date posted
- 2004-07-20
- Date terminated
- 2005-02-10
- Location
- Kennesaw, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.