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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic MiniMed(TM) Proset(TM)

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  Class 2 Device Recall Medtronic MiniMed(TM) Proset(TM) see related information
Date Initiated by Firm September 10, 2017
Create Date November 18, 2017
Recall Status1 Open3, Classified
Recall Number Z-0111-2018
Recall Event ID 78125
510(K)Number K160651  
Product Classification Tubing, fluid delivery - Product Code FPK
Product Medtronic MiniMed(TM) Pro-set(TM) (MMT-280, 281)
Code Information Lot Numbers: 6211649, 6207537 
Recalling Firm/
Medtronic Inc.
18000 Devonshire St
Northridge CA 91325-1219
For Additional Information Contact Medtronic
Manufacturer Reason
for Recall
Medtronic MiniMed(TM) Infusion Sets have the potential for over-delivery of Insulin.
FDA Determined
Cause 2
Component design/selection
Action The firm initiated its recall on 09/11/2017 by issuing a public notice, following with letters and emails. The firm also employed the use of Facebook and Twitter as well as posting on its website. The recall notice directs the customer to visit https://checklots.medtronicdiabetes.com for information on the lot numbers. Persons with additional questions may call Medtronic at 1.888.204.7616.
Quantity in Commerce 5,842 units
Distribution Worldwide
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FPK and Original Applicant = BECTON, DICKINSON AND COMPANY