Z-0109-2018 Class II Ongoing

Recalled by Medtronic Inc. — Northridge, CA

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
2,163,610 units

Product Description

Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T)

Reason for Recall

Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.

Distribution Pattern

Worldwide

Code Information

Lot Numbers: 5188321 5190185 5190186 5184968 5185467 5185468 5185469 5185470 5188322 5188323 5188324 5188325 5188326 5188327 5188328 5189476 5189477 5189478 5189521 5189522 5190187 5190188 5190189 5191046 5191047 5191355 5192532 5183060 5183061 5187300 5187301 5187556 5187557 5189051 5193052 5188329 5188330 5189053 5189054 5194937 5185690 5187558 5191357 5187559