Drug recall
DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use…
FDA recall event 71193 · Class II · DeRoyal Industries Inc
Key facts
| Event ID | 71193 |
|---|---|
| Recall numbers | Z-1642-2015 |
| Recalling firm | DeRoyal Industries Inc |
| Product type | Devices |
| Products | DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use. |
| Initiation date | Apr 17, 2015 |
| Report date | May 27, 2015 |
| Termination date | Dec 29, 2015 |
| City | Powell |
| State | TN |
| Country | United States |
| FEI number | 1043214 |
At a glance
- 1–9 Products in this recall
- 1–9 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: