CryoValve, Pulmonary Valve & Conduit SG
FDA device recall Z-1591-05 · posted 2005-09-28 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- This recall was initiated as part of the firm's retrospection review of tissues associated with complaints of alleged recipient infection.
- Action taken
- Consignees were notified by telephone and letter on 04/19/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 tissue
- Distribution
- MO, TX and Sidney Australia
- Date initiated
- 2004-04-19
- Date posted
- 2005-09-28
- Date terminated
- 2008-01-07
- Location
- Kennesaw, GA
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