Drug recall
CryoPatch SG Pulmonary Hemi-Artery Patch
FDA recall event 82380 · Class II · CryoLife, Inc.
Key facts
| Event ID | 82380 |
|---|---|
| Recall numbers | Z-1219-2019 |
| Recalling firm | CryoLife, Inc. |
| Product type | Devices |
| Products | CryoPatch SG Pulmonary Hemi-Artery Patch |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae. |
| Initiation date | Nov 21, 2016 |
| Report date | May 1, 2019 |
| Termination date | Sep 24, 2019 |
| 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: