CryoValve, Pulmonary Valve & Conduit
FDA device recall Z-1524-2008 · posted 2008-09-01 · Terminated
Recall details
- Recalling firm
- CryoLife, Inc.
- Reason for recall
- Tissues taken from a donor whose blood culture was found positive for Serratia marcescens, was distributed.
- Action taken
- Hospitals were notified by letter on 3/24/2008. They were advised not to implanted the tissue and if implanted, they do not recommend explant unless medically necessary. A self addressed, stamped post card was included to confirm receipt of the notification. Serial number 8895391 was reported implanted. Serial number 8895131 was returned to CryoLife for destruction.
- Root cause
- Material/Component Contamination
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 tissue
- Distribution
- Hospitals in DE, TN
- Date initiated
- 2008-03-26
- Date posted
- 2008-09-01
- Date terminated
- 2010-01-12
- Location
- Kennesaw, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| HUMAN HEART VALVE, CRYOVALVE SG (K033484) | Cryolife, Inc. | 2008-02-07 |