Events

Recall of Device Recall Mask adult, elastic strap style, PercentO2 Lock air entrainment system

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Salter Laboratories, Division of Regulatory Affairs.

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
    58454
  • Event Risk Class
    Class 2
  • Event Number
    Z-0112-2012
  • Event Initiated Date
    2011-03-25
  • Event Date Posted
    2011-10-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-10-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99391
  • 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, oxygen, low concentration, venturi - Product Code BYF
  • Reason
    A small number of oxygen mask components were found to have 100% obstructed airways rendering them incapable of delivering oxygen to patients undergoing respiration therapy.
  • Action
    The firm, Salter Labs, called all their customers on March 25, 2011 and asked that they hold all affected product. In addition, the firm sent an "URGENT PRODUCT RECALL" letter dated April 4, 2011 and a follow-up letter dated April 7, 2011 via e-mail and certified mail to all customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory, return any affected lots listed, contact Salter Customer Service at 1-800-235-4203 to arrange for return of affected product and complete and return the Customer Reply Form via 661-854-6816 or toll free 1-800-628-4690. Should you have any questions, please contact Salter Labs at 1-800-235-4203.

Device

Device Recall Mask adult, elastic strap style, PercentO2 Lock air entrainment system
  • Model / Serial
    Lot 022611; Product code: L150-7-50
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries of: Belgium, Canada, Colombia and Iceland.
  • Product Description
    Mask adult, elastic strap style, Percent-O2 Lock air entrainment system, w/7' tube (Linde) - 50/cs; || Salter Labs, Arvin, CA 93203 || Intended usage: respiratory therapy.
  • Manufacturer
    Salter Laboratories, Division of Regulatory Affairs

Manufacturer

Salter Laboratories, Division of Regulatory Affairs
  • Manufacturer Address
    Salter Laboratories, Division of Regulatory Affairs, 100 Sycamore Rd, Arvin CA 93203-2300
  • Source
    USFDA