FDA-Device2019-11-13Class II
Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
Insulet Corporation
Hazard
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.
Sold states
US Nationwide.
Affected count
264
Manufactured in
600 Technology Park Dr Ste 200, N/A, Billerica, MA, United States
Products
Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0347-2020Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief