Drug recall
IVEA Product Part Number 16100 Model 500A
FDA recall event 78019 · Class II · Firefly Medical, Inc.
Key facts
| Event ID | 78019 |
|---|---|
| Recall numbers | Z-3239-2017 |
| Recalling firm | Firefly Medical, Inc. |
| Product type | Devices |
| Products | IVEA Product Part Number 16100 Model 500A |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The dowel pins (P/N 16082) that fit in the left and right leg pivot castings (P/Ns 16049/16056) can rotate and gradually maneuver out of the leg casting after several hundred deployment and folding… |
| Initiation date | Aug 24, 2017 |
| Report date | Oct 11, 2017 |
| Termination date | Nov 1, 2019 |
| City | Fort Collins |
| State | CO |
| Country | United States |
| FEI number | 3011390406 |
At a glance
- 1–9 Products in this recall
- None 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: