Company: Insulet Corporation
Date of Enforcement Report: 11/13/2019
Class II

PRODUCT

Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1

• Recall Number: Z-0347-2020

REASON

There is a potential for a communication interruption following a bolus command that may result in inaccurate information presented in insulin on board (IOB), last bolus field or bolus history.

RECALLING FIRM/MANUFACTURER

Insulet Corporation on 12/18/2018. Voluntary:  Firm Initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE

264

DISTRIBUTION

Nationwide