Insulet Corporation recalls Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - Product Usage:…

Recall date

April 2, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2164-2020

FDA classification

Class II

Brand / firm

Insulet Corporation

Sold / distributed

The products were distributed to the following foreign countries: Italy, Netherlands, UK.

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.