CryoValve, Aortic & Conduit
FDA device recall Z-1296-03 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- Firm received additional information from the procurement agency indicating that the donor's serological test sample may have been sufficiently diluted by transfusion/infusion to invalidate the HIV and Hepatitis B and C screening test results.
- Action taken
- Consignees were notified by letter on 09/10/2003 and 09/12/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 unit
- Distribution
- The tissues were distributed to one hospital in CA and one physician in MN.
- Date initiated
- 2003-09-10
- Date posted
- 2003-10-15
- Date terminated
- 2004-05-06
- Location
- Kennesaw, GA
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