Recalls / —
—#158700
Product
Medtronic MiniMed(TM) Sure-T(TM) (MMT-862, 862T, 864, 864T, 866, 866T, 874, 874T, 876, 876T, 884, 886, 886T)
- FDA product code
- FPA — Set, Administration, Intravascular
- Device class
- Class 2
- Medical specialty
- General Hospital
- 510(k) numbers
- K160648
- Affected lot / code info
- 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
Why it was recalled
Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
Root cause (FDA determination)
Component design/selection
Action the firm took
The firm initiated its recall on 09/11/2017 by issuing a public notice, following with letters and emails. The firm also employed the use of Facebook and Twitter as well as posting on its website. The recall notice directs the customer to visit https://checklots.medtronicdiabetes.com for information on the lot numbers. Persons with additional questions may call Medtronic at 1.888.204.7616.
Recalling firm
- Firm
- Medtronic Inc.
- Address
- 18000 Devonshire St, Northridge, California 91325-1219
Distribution
- Distribution pattern
- Worldwide
Timeline
- Recall initiated
- 2017-09-10
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #158700. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.