Z-0111-2018 Class II Ongoing
FDA device recall Z-0111-2018 was initiated by Medtronic Inc. on September 10, 2017 and is designated Class II. Reason for recall: Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin. The recall status is ongoing. Affected quantity: 5,842 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2017
- Initiation Date
- September 10, 2017
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,842 units
Product Description
Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)
Reason for Recall
Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
Distribution Pattern
Worldwide
Code Information
Lot Numbers: 6211649, 6207537