Z-0423-2023 Class II Ongoing
FDA device recall Z-0423-2023 was initiated by Insulet Corporation on November 14, 2022 and is designated Class II. Reason for recall: The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and charging cable are melting, deforming, or discoloring due to heat generated by increased resi… The recall status is ongoing. Affected quantity: 129,086.
Recall Details
- Product Type
- Devices
- Report Date
- December 14, 2022
- Initiation Date
- November 14, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 129,086
Product Description
Omnipod 5 Automated Insulin Delivery System Product catalog numbers: PT-000409: ASM, Omnipod 5, PDM, Programmed PT-000428: Adaptor, Charging, Noetic Nuu N5004L, Horizon PDM, US PT-000429: Cable, Charging, Omnipod 5, Horizon PDM
Reason for Recall
The firm has become aware of an issue with the Omnipod 5 Controller where the Controller charging port and charging cable are melting, deforming, or discoloring due to heat generated by increased resistance in the Controller port. The excess heat may cause minor burns if touched, and the Omnipod 5 Controller may fail to charge, requiring the user to switch to their backup insulin plan.
Distribution Pattern
Domestic distribution nationwide.
Code Information
ALL serial numbers/ controller lots are currently in scope of this recall