Events

Recall of Remington Medical

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Remington Medical Inc..

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
    51962
  • Event Risk Class
    Class 2
  • Event Number
    Z-1417-2009
  • Event Initiated Date
    2009-04-06
  • Event Date Posted
    2009-05-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-05-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81760
  • 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
    Needle, aspiration and injection, reusable - Product Code GDM
  • Reason
    Incorrect needle (franseen needle, fnm-1806) was packaged as a chiba needle marked.
  • Action
    The distributor was notified on Monday, April 6, 2009 via telephone by the QA Manager and a return authorization was issued. A notification letter dated April 13, 2009 was issued via certified mail to the affected customers. The letter described the affected product, reason for recall and actions for customers. Customers were also instructed to conduct recall to user level. For questions or additional information, contact Remington Medical, Inc. by calling 800-989-0057, extension 123.

Device

Remington Medical
  • Model / Serial
    Lot Number 083665.
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution -- KY and NC.
  • Product Description
    CHIBA NEEDLE MARKED, Model CNM-1806, Size: 18 GA x 15 CM, Qty: 10 each, Remington Medical, Inc., Alpharetta, GA 30005. || The device is used as a General Purpose Aspiration and Injection Needle.
  • Manufacturer
    Remington Medical Inc.

Manufacturer

Remington Medical Inc.
  • Manufacturer Address
    Remington Medical Inc., 6830 Meadowridge Ct., Alpharetta GA 30005
  • Manufacturer Parent Company (2017)
    Remington Medical, Inc.
  • Source
    USFDA