CryoValve, Alt Pulmonary Valve
FDA device recall Z-0211-06 · posted 2005-11-30 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- Previously released tissues no longer meet CryoLife's enhanced suitability release criteria because donors possessed a positive post processing microbiological culture of 'potentially pathogenic' organisms.
- Action taken
- Consignees were notified by letter starting 11/17/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 unit
- Distribution
- AR, AZ, CA, CT, DC, FL, IL, LA, MN, NC, NH, NV, NY, TN, TX, UT, and Germany.
- Date initiated
- 2003-11-19
- Date posted
- 2005-11-30
- Date terminated
- 2009-07-02
- Location
- Kennesaw, GA
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