Reported Nov 23, 2022 · Terminated
18239: ASM Omnipod Dash PDM, insulin delivery system. PT-000010: Assembly, Dash Final PDM U100, mg/dL PT-000011:…
Insulet Corporation
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Insulet Corporation · 100 Nagog Park · Acton, MA · 01720-3440
Is this the product you have?
- 18239: ASM Omnipod Dash PDM, insulin delivery system
- PT-000010Assembly, Dash Final PDM U100
- mg/dL PT-000011Assembly, Dash Final PDM U100
- mmol/L PT-000030Assembly, 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
- Lot codes and dates
- Part Number/UDI-DI 1823910385082000009
- PT 00003010385082000122
- PT 00001010385082000139
- PT 00001110385082000146 All Serial Numbers and Lots
- Amount recalled
- 248,288 US; 167,802 OUS
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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