Drug recall
Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin…
FDA recall event 69293 · Class II · Animas Corporation
Key facts
| Event ID | 69293 |
|---|---|
| Recall numbers | Z-0136-2015 |
| Recalling firm | Animas Corporation |
| Product type | Devices |
| Products | Animas Vibe Insulin Infusion Pump. This product is indicated for continuous subcutaneous infusion of insulin for the treatment of diabetes and has a continuous glucose monitoring feature. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Animas determined that the Hebrew language translation in the Vibe Insulin Infusion Pump was incorrect and could lead to potential patient confusion. In addition, one line of Hebrew text was omitted… |
| Initiation date | Jun 10, 2014 |
| Report date | Nov 5, 2014 |
| Termination date | Sep 2, 2015 |
| City | West Chester |
| State | PA |
| Country | United States |
| FEI number | 3002920072 |
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: