Recall Z-0347-2020— Insulet Corporation
Class II · Terminated
Class II FDA medical device recall by Insulet Corporation, initiated 2018-12-18, terminated 2020-05-13. It names one FDA 510(k) clearance: K180045. Product: Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1. 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
- Insulet Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-12-18
- Terminated
- 2020-05-13
- Firm location
- Billerica, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.