Events

Recall of Device Recall Safco Supergrade Earloop Masks

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Safco Dental Supply Co. 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
    26382
  • Event Risk Class
    Class 2
  • Event Number
    Z-0944-03
  • Event Initiated Date
    2003-06-03
  • Event Date Posted
    2003-06-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27591
  • 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
    The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration.
  • Action
    Recalled by letter dated 5/30/03, informing the dentists that the earloop masks were mislabled with the wrong particle filtration efficiency. Correction labels were included with the letter for the dentists to field correct the boxes of masks in their office inventory.

Device

Device Recall Safco Supergrade Earloop Masks
  • Model / Serial
    all lots of product code 372-8114 (blue) and 372-8125 (pink)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide
  • Product Description
    Supergrade Earloop Masks, surgical mask; 50 masks per box; Distributed by Safco Dental Supply Co., Northbrook, IL 60062
  • Manufacturer
    Safco Dental Supply Co. Inc.

Manufacturer

Safco Dental Supply Co. Inc.
  • Manufacturer Address
    Safco Dental Supply Co. Inc., 2121 Shermer, Northbrook IL 60062
  • Source
    USFDA