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Terminated

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

FDA Recall Z-0347-2020 · Posted None

Recalling FirmInsulet Corporation
Recall StatusTerminated
Product CodeLZG
Date Initiated2018-12-18
Date Terminated2020-05-13
Product Quantity264

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.

Firm Action

Urgent Medical Device Correction letters dated 12/18/18 were sent to customers.

Root Cause

Software design

Distribution Pattern

US Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K180045Omnipod DASH Insulin Management SystemInsulet Corporation · 2018-06-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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