PlainRecalls
FDA Devices Critical Class I Terminated

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.

Reported: November 23, 2022 Initiated: October 17, 2022 #Z-0154-2023

Product 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.

Reason for Recall

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.

Details

Recalling Firm
Insulet Corporation
Units Affected
248,288 US; 167,802 OUS
Distribution
Worldwide Distribution: US nationwide, Canada, Europe, Australia, and the Middle East.
Location
Acton, MA

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Insulet Corporation. Units affected: 248,288 US; 167,802 OUS.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 23, 2022. Severity: Critical. Recall number: Z-0154-2023.

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