Recall Z-1561-2011
CryoLife, Inc. · initiated February 17, 2011
Product
Pulmonary Hemi-Artery SG Used in heart surgery
Codes / lots: Serial No. 9528019 - Model SGPH00
Reason for recall
Staphylococcus aureus (not methicillin resistant) identified in companion tissue.
FDA-determined cause: Other
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.
Details
- Recall number
- Z-1561-2011
- Initiated
- February 17, 2011
- Posted by FDA
- March 4, 2011
- Terminated
- April 24, 2012
- Product code
- DXZ – Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Quantity
- One
- Distribution
- Nationwide Distribution including AZ & NV
- Recalling firm
- CryoLife, Inc., Kennesaw, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1560-2011 | Pulmonary Valve & Conduit SG Used in heart surgeryStaphylococcus aureus (not methicillin resistant) identified in companion tissue. | 02/17/2011Terminated |