Z-0347-2020 Class II Terminated
FDA device recall Z-0347-2020 was initiated by Insulet Corporation on December 18, 2018 and is designated Class II. 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. The recall status is terminated (terminated May 13, 2020). Affected quantity: 264.
Recall Details
- Product Type
- Devices
- Report Date
- November 13, 2019
- Initiation Date
- December 18, 2018
- Termination Date
- May 13, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 264
Product Description
Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
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.
Distribution Pattern
US Nationwide.
Code Information
Lot Numbers L000120, L000121, L000122, L000123, L000124, L000131, L000132, L000133, L000135, L000136