Drug recall
Pulmonary Hemi-Artery SG Used in heart surgery
FDA recall event 67182 · Class II · CryoLife, Inc.
Key facts
| Event ID | 67182 |
|---|---|
| Recall numbers | Z-0809-2014 |
| Recalling firm | CryoLife, Inc. |
| Product type | Devices |
| Products | Pulmonary Hemi-Artery SG Used in heart surgery |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Nov 22, 2013 |
| Report date | Jan 29, 2014 |
| Termination date | Feb 20, 2014 |
| City | Kennesaw |
| State | GA |
| Country | United States |
| FEI number | 3001451326 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: