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Insulet Corporation recalls Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage:
Recalled June 10, 2020 · FDA recall Z-2164-2020 · Insulet
Hazard
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. · FDA Class II
Units
400
Sold at
The products were distributed to the following foreign countries: Italy, Netherlands, UK.
Description
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.
Product
Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Manufacturer(s)
Insulet Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →