Insulet Corporation Recall 90987
Description: 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM U100, mmol/L PT-000030: Assembly, DASH PDM, Canada Remote Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump (Pod) *The part numbers above may be incorporated into higher level assemblies such as DASH Starter Kits.
Insulet Corporation Recall 90987 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0154-2023 |
| Event ID | 90987 |
| Event Description | 18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011: Assembly, Dash Final PDM U100, mmol/L PT-000030: Assembly, DASH PDM, Canada Remote Controller (Personal Diabetes Manager or PDM) associated with Insulin Pump (Pod) *The part numbers above may be incorporated into higher level assemblies such as DASH Starter Kits. |
| Product Type | Devices |
| Distribution | Worldwide Distribution: US nationwide, Canada, Europe, Australia, and the Middle East. |
| Quantity | 248,288 US; 167,802 OUS |
| Recall Reason | The firm has become aware of PDM battery issues, including battery swelling, fluid leaking from the battery, and extreme overheating, which may pose a fire hazard. The firm has received a complaint alleging fire as a result of thermal energy from a DASH PDM. |
| Device Classification | 20221123 |
| Device Code Info | Part Number/UDI-DI 18239 : 10385082000009 PT 000030: 10385082000122 PT 000010: 10385082000139 PT 000011: 10385082000146 All Serial Numbers and Lots |
| Center Classification Date | 20221115 |
| Recall Initiation Date | 20221017 |
| Recalling Firm | Insulet Corporation |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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