FDA recall Z-0107-2018

Product

Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

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-0107-2018