Reported Jun 10, 2020 · Terminated
Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage:…
Insulet Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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?
- Omnipod DASH Insulin Management System (mg/dL configuration)
- Catalog Number PT000010 M/DINT1D001MG -
- Product Usageis intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin
- Lot codes and dates
- UDIPT - 000010 - 10385082000139
- Lot NumbersL000202
- Amount recalled
- 400
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Why it was recalled
After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before suggesting a bolus amount.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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