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

Recall date

December 18, 2018

Source

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

Recall number

Z-0347-2020

FDA classification

Class II

Brand / firm

Insulet Corporation

Sold / distributed

US Nationwide.

Why it was recalled

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.

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, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1