Events

Recall of Device Recall INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR

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

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
    52170
  • Event Risk Class
    Class 3
  • Event Number
    Z-1576-2009
  • Event Initiated Date
    2008-07-23
  • Event Date Posted
    2009-07-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-07-17
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82392
  • 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
    Respirator, surgical - Product Code MSH
  • Reason
    Display boxes labeled as frn95-mlez, medium/large size respirators were inadvertently mixed with display boxes labeled for frn95-sez small size respirators.
  • Action
    The recalling process was initiated on July 23, 2007. The affected distributor was notified of the recall through a certified recall letter with an attached Customer Response card. The distributor was instructed to notify and obtain recall product from their customers and return all affected product to Inovel. Direct questions about the recall to Inovel at 1-866-546-6835.

Device

Device Recall INOVEL HEALTH CARE N95 PARTICULATE RESPIRATOR
  • Model / Serial
    Lot Number: 060713-244.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US (Illinois only).
  • Product Description
    Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010.
  • Manufacturer
    Inovel LLC

Manufacturer

Inovel LLC
  • Manufacturer Address
    Inovel LLC, 10111 Jefferson Blvd, Culver City CA 90232-3509
  • Source
    USFDA