Aortic Valve & Conduit
FDA device recall Z-0842-2007 · posted 2007-06-07 · Terminated
Recall details
- Recalling firm
- CryoLife, Inc.
- Reason for recall
- Donor tissue was released prior to information received regarding a pericardial effusion.
- Action taken
- Both physicians were contacted by telephone on 4/17 & 18/2007. Both tissues were returned to CryoLife
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 tissue
- Distribution
- AZ, CO
- Date initiated
- 2007-04-17
- Date posted
- 2007-06-07
- Date terminated
- 2007-12-31
- Location
- Kennesaw, GA
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