Reported Nov 13, 2019 · Terminated

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

Insulet Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Insulet Corporation · 600 Technology Park Dr Ste 200 · Billerica, MA · 01821-4150

Is this the product you have?

  • Omnipod DASH Insulin Management System
  • Product Catalog Number 18239 M/DPDM USA1 D001 MG USA1
Lot codes and dates
    • Lot Numbers L000120
    • L000121
    • L000122
    • L000123
    • L000124
    • L000131
    • L000132
    • L000133
    • L000135
    • L000136
Amount recalled
264

Where it was sold

  • 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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated May 13, 2020 · Data as of Sep 19, 5:25 PM UTC

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