CryoValve Pulmonary Valve and Conduit
FDA device recall Z-1057-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- The Amphotericin B Intermediate (G10030), one of the components of the antimicrobial solution, had reached expiration at the time it was utilized to manufacture the Combo Antibiotic Stock Solution (G10070).
- Action taken
- Consignees were notified by letter on 06/17/2004 and 06/18/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 3 unit
- Distribution
- CA, OH, OR, PA.
- Date initiated
- 2004-06-17
- Date posted
- 2004-07-20
- Date terminated
- 2005-03-07
- Location
- Kennesaw, GA
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