Pulmonary Hemi-Artery SG Used in heart surgery
FDA device recall Z-1561-2011 · posted 2011-03-04 · Terminated
Recall details
- Recalling firm
- CryoLife, Inc.
- Reason for recall
- Staphylococcus aureus (not methicillin resistant) identified in companion tissue.
- Action taken
- CryoLife Inc. issued a letter to the physician on February 17, 2011, advising him of the results of the testing performed on a companion cardiac allograft. The letter did not recommend explant of the allograft or special antimicrobial treatment of the patient unless medically necessary. The physician was asked to complete and return the enclosed, stamped, self-addressed postcard affirming the receipt of the notification. For any questions the physician was advised to call 770-419-3355.
- Root cause
- Other
- Status
- Terminated
- Product code
- DXZ
- Quantity affected
- One
- Distribution
- Nationwide Distribution including AZ & NV
- Date initiated
- 2011-02-17
- Date posted
- 2011-03-04
- Date terminated
- 2012-04-24
- Location
- Kennesaw, GA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CRYOPATCH SG PULMONARY HUMAN CARDIAC PATCH (K101866) | Cryolife, Inc. | 2010-07-23 |