Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

BD FlowSmart Set MiniMed Pro-set Rx Only Distributed by Medtronic Recalled by Becton Dickinson & Company Due to Patients are reporting high blood glucose (HBG) levels...

Date: December 23, 2016
Company: Becton Dickinson & Company
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Becton Dickinson & Company directly.

Affected Products

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

Quantity: 57,750 units

Why Was This 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.

Where Was This Sold?

This product was distributed to 1 state: CA

Affected (1 state)Not affected

About Becton Dickinson & Company

Becton Dickinson & Company has 169 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report