CryoValve, Pulmonary Valve and Conduit
FDA device recall Z-0814-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- CryoLife was notified by the Tennessee Department of Health, that a recipient had contracted a Group A Streptococcus infection from orthopedic tissue originating from the same donor as CryoLife donor 69347.
- Action taken
- The consignee was contacted by telephone by the CryoLife Medical Director on 01/30/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 unit
- Distribution
- The tissue was distributed to one physician in IN.
- Date initiated
- 2004-01-30
- Date posted
- 2004-07-20
- Date terminated
- 2004-04-15
- Location
- Kennesaw, GA
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