Recall – Insulin management system communication interruption

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

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62304, FDA, and Emerging Standards for Medical Device and HealthIT
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Dates:  February 4-6, 2020
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QSS Software Validation
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Location: Boston, MA, USA
Dates:  June 2-4, 2020
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Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.