FDA Device recall Z-0809-2014
Pulmonary Hemi-Artery SG Used in heart surgery
- FDA Device
- Class II
- terminated
- Published 2014-01-29
On 2014-01-29 the FDA classified a Class II recall of Pulmonary Hemi-Artery SG Used in heart surgery by Cryolife, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0809-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-22 |
| Published | 2014-01-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Cryolife |
| Distribution | CA |
Product
Pulmonary Hemi-Artery SG Used in heart surgery
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.
Identifiers
| code_info | Serial No. 10119759, Model SGPH00 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0809-2014%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.