FDA-Device2017-11-29Class II
Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
Medtronic Inc.
Hazard
Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
Sold states
Worldwide
Affected count
1,898,570 units
Manufactured in
18000 Devonshire St, N/A, Northridge, CA, United States
Products
Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0108-2018Don't want to check this manually?
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