Company: Insulet Corporation
Date of Enforcement Report: 6/10/2020
Class II

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.

Recall Number: Z-2164-2020

REASON

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 amount of IOB before suggesting a bolus amount.

RECALLING FIRM/MANUFACTURER

Insulet Corporation on 4/2/2020. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

400

DISTRIBUTION

International