Pulmonary Hemi-Artery SG Used in heart surgery
- Company
- Cryolife Inc
- Recall Initiated
- November 22, 2013
- Posted
- January 23, 2014
- Terminated
- February 20, 2014
- Recall Number
- Z-0809-2014
- Quantity
- One
- Firm Location
- Kennesaw, GA
Reason for Recall
Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the administration of normal saline to the donor prior to death.
Distribution
US distribution in CA.
Lot / Code Info
Serial No. 10119759, Model SGPH00
Root Cause
Other
Action Taken
CryoLife sent an Urgent Human Tissue Recall letter dated November 22, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to contact CryoLife to arrange for the return of the affected product. If the affected product had been implanted or discarded, customers should provide information regarding the status of the affected product on the attached self-addressed postcard. Customers with questions were instructedto contact the Field Assurance Department at 800-438-8285. For questions regarding this recall call 770-419-3355.