Events

Recall of ReliOn

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
    30390
  • Event Risk Class
    Class 3
  • Event Number
    Z-0569-05
  • Event Initiated Date
    2004-10-22
  • Event Date Posted
    2005-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=35785
  • 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
    Syringe, Piston - Product Code FMF
  • Reason
    Syringes labeled as 5/16 inch product (30 ga) actually contained the 1/2 inch product (28 ga).
  • Action
    BD has sent letters to the distributor McKesson Inc and the retailer Wal-Mart Inc.

Device

ReliOn
  • Model / Serial
    Batch # 4083690
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The syringes were sent to McKesson Corp, 120 Senlac Drive, Carrollton, TX 75006 who then sold them to Wal-Mart Corp, 702 SW 8th Street, Bentonville, AR 72716. There are no other customers.
  • Product Description
    ReliOn Insulin Syringe 0.5cc 30 Gauge 5/16 inch (8mm) Needle (U-100 Insulin). NDC 81306-0515-23.
  • 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