Recall Z-0347-2020 ยท LZG Pump, Infusion, Insulin
Insulet Corporation
Omnipod DASH Insulin Management System, Product Catalog Number 18239 M/D: PDM USA1 D001 MG USA1
| Date | Dec 18, 2018 |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | Urgent Medical Device Correction letters dated 12/18/18 were sent to customers. |
| Quantity | 264 |
| Distribution | US Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180045 | Omnipod DASH Insulin Management System Insulet Corporation, Jun 1, 2018 |