Z-2164-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 10, 2020
- Initiation Date
- April 2, 2020
- Termination Date
- September 14, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 400
Product Description
Omnipod DASH Insulin Management System (mg/dL configuration), Catalog Number PT000010 M/D: INT1D001MG - 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: PT - 000010 - 10385082000139; Lot Numbers: L000202