Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
Reported: November 13, 2019 Initiated: December 18, 2018 #Z-0347-2020
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.
Details
- Recalling Firm
- Insulet Corporation
- Units Affected
- 264
- Distribution
- US Nationwide.
- Location
- Billerica, MA
Frequently Asked Questions
What product was recalled? ▼
Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1. Recalled by Insulet Corporation. Units affected: 264.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 13, 2019. Severity: Moderate. Recall number: Z-0347-2020.
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