CryoValve, Conduit and Pulmonary Valve and Conduit
FDA device recall Z-1484-04 · posted 2004-09-23 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- CryoLife received information regarding a positive culture for Group A Streptococcus infection in a recipient of tissue procured from the attached donor.
- Action taken
- Consignee was notified via telephone on 4/12/2004. The tissue was returned and destroyed.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 tissue
- Distribution
- NM
- Date initiated
- 2004-04-12
- Date posted
- 2004-09-23
- Date terminated
- 2005-05-10
- Location
- Kennesaw, GA
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