Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
FDA Recall #Z-0347-2020 — Class II — December 18, 2018
Product Description
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.
Recalling Firm
Insulet Corporation — Billerica, MA
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
264
Distribution
US Nationwide.
Code Information
Lot Numbers L000120, L000121, L000122, L000123, L000124, L000131, L000132, L000133, L000135, L000136
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated