Heart-valve, allograft
FDA device recall Z-1187-03 · posted 2003-08-28 · Terminated
Recall details
- Recalling firm
- Cryolife Inc
- Reason for recall
- Donor of aortic valve had procurement cultures that were positive for E-coli.
- Action taken
- A CryoLife representative contacted the consignee by telephone on 2/4/2002 to inform her of the recall action. The graft was returned to CryoLife and destroyed on/about 2/11/2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- MIE
- Quantity affected
- 1 unit
- Distribution
- Allograft was distrbuted to one medical facility in CA. No government or foreign accounts involved.
- Date initiated
- 2003-02-04
- Date posted
- 2003-08-28
- Date terminated
- 2003-08-28
- Location
- Kennesaw, GA
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