CryoValve Allograft, Heart valve.
FDA device recall Z-0719-03 · posted 2003-04-10 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- Pre-processing cultures detected certain microorganisms in donor tissue.
- Action taken
- Consignees were first notified by telephone on 2/24/2003 with follow up letter on March 6, 2003 and were advised, if the tissue had not yet been implanted, to remove tissue from implantable inventory and place it into quarantine. CryoLife will provide specific instructions for returning the tissue. A stamped, self-addressed postcard was provided to confirm receipt of the notice and to provide information regarding the disposition of the tissue.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 2 individual heart valve allografts.
- Distribution
- Heart allografts were distributed to two hospitals in OH and Quebec, Canada.
- Date initiated
- 2003-02-24
- Date posted
- 2003-04-10
- Date terminated
- 2004-07-23
- Location
- Kennesaw, GA
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