Events

Recall of Device Recall BD

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Becton Dickinson & Company.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76294
  • Event Risk Class
    Class 2
  • Event Number
    Z-1897-2017
  • Event Initiated Date
    2016-12-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-11-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152719
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Set, administration, intravascular - Product Code FPA
  • Reason
    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.
  • 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.

Device

Device Recall BD
  • Model / Serial
    6203871 30-Jun-19 6203860 30-Jun-19 6207535 30-Jun-19 6211649 31-Jul-19 6207537 30-Jun-19 6211650 31-Jul-19
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the state of : CA
  • 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
  • Manufacturer
    Becton Dickinson & Company

Manufacturer

Becton Dickinson & Company
  • Manufacturer Address
    Becton Dickinson & Company, 1 Becton Dr, Franklin Lakes NJ 07417-1815
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA