medical Class II Updated 2020-06-10

Insulet Corporation recalls Omnipod DASH Insulin Management System (mmol/L configuratio

Recalled Product

Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.

Hazard / Issue

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.

Issued by

FDA

Distribution: The products were distributed to the following foreign countries: Italy, Netherlands, UK.
Lot/Code Info: UDI: PT000011 10385082000146; Lot Numbers: L000200, L000201, L000203, L000209, L000210
View official government recall

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