CryoValve, Pulmonary Valve & Conduit SG
FDA device recall Z-0479-06 · posted 2006-02-04 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- During a retrospective review, CryoLife identified positive microbiological culture results for donor tissues associated with various allografts.
- Action taken
- Consignees were notified by letter dated May 6, May 11, or May 12, 2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 3 units
- Distribution
- FL, NC , NE, NV, NY, TN, TX, UT, WA, and Canada
- Date initiated
- 2004-05-06
- Date posted
- 2006-02-04
- Date terminated
- 2010-06-28
- Location
- Kennesaw, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.