Events

Recall of Device Recall dynarex brand Ear Loop Procedure Masks

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

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
    25310
  • Event Risk Class
    Class 2
  • Event Number
    Z-0572-03
  • Event Initiated Date
    2002-12-31
  • Event Date Posted
    2003-02-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25577
  • 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
    Mask, Surgical - Product Code FXX
  • Reason
    Product labeled as 'latex free' but recent tests indicate that it contains minute amounts of latex.

Device

Device Recall dynarex brand Ear Loop Procedure Masks
  • Model / Serial
    Reorder No. 2201, Lot Number 14929, Barcode # 16784 22012
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Medical/dental supply distributors nationwide and Puerto Rico, and 2 foreign accounts in the Bahamas.
  • Product Description
    Ear Loop Procedure Masks, For one time use only, Glass-Free, Reorder No. 2201, packed in a cardboard box (unit box). Manufactured for dynarex Corporation, Brewster, NY 10509. Made in China. || Product is labeled with a Latex-free symbol that states ''This product does not contain any natural rubber latex'' . || A total of 50 masks are in one unit box, and 12 boxes are placed into one shipping carton/case.
  • Manufacturer
    Dynarex Corporation

Manufacturer

Dynarex Corporation
  • Manufacturer Address
    Dynarex Corporation, 10 Glenshaw St, Orangeburg NY 10962
  • Source
    USFDA