Medical device recalls Moderate risk

Becton Dickinson & Company recalls BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic MiniMed Inc. 8006464633 8185765555 Legal Manufacturer…

Recall date
December 23, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1897-2017
FDA classification
Class II
Brand / firm
Becton Dickinson & Company
Sold / distributed
US Distribution to the state of : CA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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

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