FDA recall Z-0347-2020

Product

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

Reason for recall

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.

Distribution

US Nationwide.

Key facts

Status

Terminated

Initiation date

2018-12-18

Report date

2019-11-13

Termination date

2020-05-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Billerica, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0347-2020