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Recall Observatory FDA recall evidence

Device product

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

Z-0347-2020

December 18, 2018

Class II

Product summary

Firm
Insulet Corporation
Event
Event 82003
Status
Terminated
Classification
Class II
Quantity
264
Official record key
device-enforcement:Z-0347-2020

Official wording

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.

Code information: Lot Numbers L000120, L000121, L000122, L000123, L000124, L000131, L000132, L000133, L000135, L000136

Distribution pattern: US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.