BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 81...
FDA Recall #Z-1897-2017 — Class II — December 23, 2016
Product Description
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
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.
Recalling Firm
Becton Dickinson & Company — Franklin Lakes, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
57,750 units
Distribution
US Distribution to the state of : CA
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated