CryoValve Allograft heart valve
FDA device recall Z-0675-03 · posted 2003-03-21 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- An allograft associated with this donor has been linked to an alleged infection.
- Action taken
- A CryoLife Technical Representative notified the consignee by telephone on/about 1/23/2003 to determine the disposition of the allograft. Allograft SID 7291867 (SGPV00) was located in storage at the St. Vincent''s Hospital, Indianapolis, IN. A CryoLife representative visited this site on 01/30/2003 to remove the allograft from inventory and return the tissue to CryoLife. After arrival at CryoLife on 02/03/2003, discard of the tissue was initiated following standard procedures for human tissue waste destruction
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 unit
- Distribution
- The unit was distributed to one Hospital facility in IN. There are no foreign or government accounts involved.
- Date initiated
- 2003-01-23
- Date posted
- 2003-03-21
- Date terminated
- 2004-03-22
- Location
- Kennesaw, GA
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