Recall Z-0107-2018— Medtronic Inc.

Name: FDA recall Z-0107-2018
Creator: U.S. Food and Drug Administration
Published: 2017-09-10

Class II · Ongoing

Class II FDA medical device recall by Medtronic Inc., initiated 2017-09-10. It names one FDA 510(k) clearance: K160648. Product: Medtronic MiniMed(TM) Quick-set(TM) (MMT-394, 394T, 399, 399T, 387, 387T, 398, 398T, 397, 397T, 386, 386T, 396, 396T). Reason: Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin..

Recalling firm: Medtronic Inc.
Classification: Class II
Status: Ongoing
Initiated: 2017-09-10
Firm location: Northridge, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K160648 — MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S·cleared 2016-08-10

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.