Insulet Corporation: 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 PD

Hazard

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 from the source

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. Distribution: Worldwide Distribution: US nationwide, Canada, Europe, Australia, and the Middle East. Quantity: 248,288 US; 167,802 OUS Lot/code info: Part Number/UDI-DI 18239 : 10385082000009 PT 000030: 10385082000122 PT 000010: 10385082000139 PT 000011: 10385082000146 All Serial Numbers and Lots

UPC codes

10385082000009, 10385082000122, 10385082000139, 10385082000146

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.