FDA-Device2017-11-29Class II

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

Medtronic Inc.
Hazard

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

Sold states
Worldwide
Affected count
3,971,030 units
Manufactured in
18000 Devonshire St, N/A, Northridge, CA, United States
Products
Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T)

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0107-2018

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