CryoValve Pulmonary Valve SG
- Company
- Cryolife Inc
- Recall Initiated
- June 17, 2004
- Posted
- July 20, 2004
- Terminated
- March 7, 2005
- Recall Number
- Z-1056-04
- Quantity
- 1 unit
- Firm Location
- Kennesaw, GA
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).
Distribution
CA, OH, OR, PA.
Lot / Code Info
Device Donor number: 64212, Serial Number: 7887101, Model Number: SGPV10
Root Cause
Other
Action Taken
Consignees were notified by letter on 06/17/2004 and 06/18/2004.
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