Z-2165-2020 Class II Terminated
FDA device recall Z-2165-2020 was initiated by Insulet Corporation on Apr 2, 2020 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Sep 14, 2021). Affected quantity: 1773.
Recall details
- Product Type
- Devices
- Report Date
- Jun 10, 2020
- Initiation Date
- Apr 2, 2020
- Termination Date
- Sep 14, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1773
Product description
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 for recall
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.
Distribution pattern
The products were distributed to the following foreign countries: Italy, Netherlands, UK.
Code information
UDI: PT000011 10385082000146; Lot Numbers: L000200, L000201, L000203, L000209, L000210
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2165-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026