CryoValve Allograft, Heart valve
This recall has been terminated (originally issued March 21, 2003).
- Company
- Cryolife Inc
- Recall Initiated
- February 4, 2003
- Posted
- March 21, 2003
- Terminated
- July 16, 2003
- Recall Number
- Z-0672-03
- Quantity
- 2 units
- Firm Location
- Kennesaw, GA
- Official Source
- View on FDA website ↗
Reason for Recall
Microorganisms were detected in distributed allografts.
Distribution
The allografts were distributed to hospitals located in OK and British Columbia, Canada. There were no government accounts.
Lot / Code Info
Donor #60084, Serial #7769926, Model #PV00 and Donor #55139, Serial #7165235, Model #SGPV00.
Root Cause
Other
Action Taken
CryoLife Technical Representatives were notified by telephone on 02/04/2003 and 02/24/2003. Representatives subsequently notified their accounts via letter on/about 02/25/2003 informing the consignees of the removal and advised them not to implant the tissue if it has not been implanted and to place into quarantine. Consignees were to contact CryoLife''s Regulatory Affairs Department Field Assurance, who will issue a Return Materials Authorization (RMA) number and will provide specific instructions for returning the tissue. A self addressed, stamped postcard was included to provide a response regarding the disposition of the tissue. Health Canada was notified of all voluntary actions on the allografts distributed in Canada.