CryoValve Allograft, Aortic Valve & Conduit
FDA device recall Z-0988-03 · posted 2003-07-10 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- Donor of distributed allograft was diagnosed with dilated/ischemic cardiomyopathy.
- Action taken
- The hospital was notified by letter on 5/05/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 unit
- Distribution
- Unit was distributed to one hospital in CA.
- Date initiated
- 2003-05-05
- Date posted
- 2003-07-10
- Date terminated
- 2003-07-10
- Location
- Kennesaw, GA
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