Device product
Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)
Z-0111-2018
Product summary
- Firm
- Medtronic Inc.
- Event
- Event 78125
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,842 units
- Official record key
device-enforcement:Z-0111-2018
Official wording
Reason: Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
Code information: Lot Numbers: 6211649, 6207537
Distribution pattern: Worldwide
Derived failure modes
-
Unknown
Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.