Events

Recall of ComfortGel Nasal Mask

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Respironics, 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
    27436
  • Event Risk Class
    Class 1
  • Event Number
    Z-0178-04
  • Event Date Posted
    2003-12-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-03-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=29870
  • 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
    Ventilator, Non-Continuous (Respirator) - Product Code BZD
  • Reason
    Product does not contain built in exhalation port.
  • Action
    The recalling firm telephoned the direct accounts to inform them of the problem and the need to return the product.

Device

ComfortGel Nasal Mask
  • Model / Serial
    Part number 1009041; Lot numbers 030612, 030418, 030417, 030415, 030409, 030321, 030320, 030316, 030312, 030311, 030310, 030306, 030305, 030303, and 030228.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The products were shipped to sleep centers nationwide and in Canada.
  • Product Description
    ComfortGel Nasal Mask size small
  • Manufacturer
    Respironics, Inc.

Manufacturer

Respironics, Inc.
  • Manufacturer Address
    Respironics, Inc., 1001 Murry Ridge Lane, Murrysville PA 15668
  • Source
    USFDA