Pulmonary Hemi-Artery SG Used in heart surgery — Class II medical device recall Z-0809-2014
Terminated recall by CryoLife, Inc., reported 2014-01-29, distributed in CA. Serological testing for the donor was performed with a blood sample that may have been hemodiluted due to the
| Recall number | Z-0809-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CryoLife, Inc., Kennesaw, GA, United States |
| Recall initiated | 2013-11-22 |
| Classified | 2014-01-23 |
| Reported by FDA | 2014-01-29 |
| Terminated | 2014-02-20 |
| Distributed | CA |
| Serial numbers | 10119759 |
| Model numbers | GPH00 |
Product
Pulmonary Hemi-Artery SG Used in heart surgery
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.
Machine access
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Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.