Drug recall
Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
FDA recall event 82003 · Class II · Insulet Corporation
Key facts
| Event ID | 82003 |
|---|---|
| Recall numbers | Z-0347-2020 |
| Recalling firm | Insulet Corporation |
| Product type | Devices |
| Products | Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history. |
| Initiation date | Dec 18, 2018 |
| Report date | Nov 13, 2019 |
| Termination date | May 13, 2020 |
| City | Billerica |
| State | MA |
| Country | United States |
| FEI number | 3004464228 |
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: