FDA Device recall Z-2165-2020
Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for sub…
- FDA Device
- Class II
- terminated
- Published 2020-06-10
On 2020-06-10 the FDA classified a Class II recall of Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for sub… by Insulet, citing after the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2165-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-02 |
| Published | 2020-06-10 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Insulet |
| Distribution | n/a |
Product
Omnipod DASH Insulin Management System (mmol/L configuration), Catalog Number PT000011 M/D: INT1D001MM - Product Usage: is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin.
Reason
After the device has been in use for about 2 months, data processing in the PDM can be slowed such that the Bolus Calculator fails to accurately subtract the correct amout of IOB before suggesting a bolus amount.
Identifiers
| code_info | UDI: PT000011 10385082000146; Lot Numbers: L000200, L000201, L000203, L000209, L000210 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2165-2020%22
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