Events

Recall of Paradigm Link -- Blood Glucose Monitor.

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
    34292
  • Event Risk Class
    Class 2
  • Event Number
    Z-0562-06
  • Event Initiated Date
    2006-01-05
  • Event Date Posted
    2006-02-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-09-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43539
  • 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
    System, Test, Blood Glucose, Over The Counter - Product Code NBW
  • Reason
    Bd blood glucose monitors may inadvertently switch the unit of measure from mg/dl to mmol/l or vice versa during battery insertion or when a meter is dropped.
  • Action
    Recall notifications letters began mailing on 1/5/2006 to distributors, retailers, and DME providers. Healthcare professionals and consumers mailings will be during the week of 1/9/2006

Device

Paradigm Link -- Blood Glucose Monitor.
  • Model / Serial
    All lots under the following Catalog Numbers:  322200; 322201; 322202; 322203; 322204; 322205; 322206; 322207.
  • Product Classification
    Clinical Chemistry and Clinical Toxicology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The firm distributes their blood glucose monitors Nationwide to distributors, retailers, durable Medical Equipment providers, Healthcare Professionals, and consumers. Foreign accounts include locations in Canada and Germany. There is one VA account.
  • Product Description
    Paradigm Link -- Blood Glucose Monitor.
  • 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