Recall Z-2165-2020— Insulet Corporation
Class II · Terminated
Class II FDA medical device recall by Insulet Corporation, initiated 2020-04-02, terminated 2021-09-14. It names one FDA 510(k) clearance: K192659. 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..
- Recalling firm
- Insulet Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-02
- Terminated
- 2021-09-14
- Firm location
- Acton, 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 (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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.