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U.S. Department of Health and Human Services

Class 2 Device Recall BD

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  Class 2 Device Recall BD see related information
Date Initiated by Firm December 23, 2016
Create Date May 01, 2017
Recall Status1 Terminated 3 on November 09, 2017
Recall Number Z-1897-2017
Recall Event ID 76294
510(K)Number K160651  
Product Classification Set, administration, intravascular - Product Code FPA
Product BD FlowSmart Set MiniMed Pro-set Rx Only
Distributed by Medtronic MiniMed Inc.
8006464633
8185765555

Legal Manufacturer

Becton, Dickinson and Company
USA

BD Medical-Diabetes Care
Becton Dickinson France SAS
Code Information 6203871 30-Jun-19 6203860 30-Jun-19 6207535 30-Jun-19 6211649 31-Jul-19 6207537 30-Jun-19 6211650 31-Jul-19 
Recalling Firm/
Manufacturer		 Becton Dickinson & Company
1 Becton Dr
Franklin Lakes NJ 07417-1815
For Additional Information Contact Ms. Leslie Robinson-Frye
201-847-6800
Manufacturer Reason
for Recall		 Patients are reporting high blood glucose (HBG) levels while using the MiniMed Pro-set and also noticed the catheter of the infusion set was bent/kinked.
FDA Determined
Cause 2		 Device Design
Action Becton Dickinson (BD) notified their sole customer Medtronic via e-mail on December 26, 2016. BD recommends that Medtronic notify their customers of the situation. For further questions, please call (201) 847-6800.
Quantity in Commerce 57,750 units
Distribution US Distribution to the state of : CA
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FPA and Original Applicant = BECTON, DICKINSON AND COMPANY
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