CryoValve, Pulmonary Valve and Conduit
FDA device recall Z-0747-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- CryoLife received additional information after release of tissue indicating the donor had repeatedly reactive test results for antibody to HCV (EIA) in 1995.
- Action taken
- Consignees were notified by telephone on 02/18/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 unit
- Distribution
- DC, TX
- Date initiated
- 2004-02-18
- Date posted
- 2004-07-20
- Date terminated
- 2004-03-30
- Location
- Kennesaw, GA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.