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