FDA recall Z-0108-2018

Product

Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)

Reason for recall

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

Distribution

Worldwide

Key facts

Status

Ongoing

Initiation date

2017-09-10

Report date

2017-11-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Northridge, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0108-2018