Device product
Pulmonary Hemi-Artery SG Used in heart surgery
Z-0809-2014
Product summary
- Firm
- CryoLife, Inc.
- Event
- Event 67182
- Status
- Terminated
- Classification
- Class II
- Quantity
- One
- Official record key
device-enforcement:Z-0809-2014
Official wording
Reason: 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.
Code information: Serial No. 10119759, Model SGPH00
Distribution pattern: US distribution in CA.
Derived failure modes
-
Unknown
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.