Events

Recall of Device Recall Inovel 3000 series Healthcare N95 Particulate Respirator and Surgical Mask

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
    34658
  • Event Risk Class
    Class 3
  • Event Number
    Z-0587-06
  • Event Initiated Date
    2006-02-20
  • Event Date Posted
    2006-03-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-01-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=44389
  • 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
    Mislabeling-a customer reported mislabeled product display boxes. review of complaint samples and inventory confirmed that some product display boxes are labeled with incorrect model/size number.
  • Action
    The recalling process will be initiated by 2/22/06. Distributors will be notified of the recall through a certified recall letter and they will in turn notify and recall product from their customers and return all affected product to Inovel.

Device

Device Recall Inovel 3000 series Healthcare N95 Particulate Respirator and Surgical Mask
  • Model / Serial
    Lot Number 051130-161
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide (CA, FL, ME, NY, OH, WI)
  • Product Description
    Particulate Respirator and Surgical Mask, Inovel 3000 series Healthcare N95 Model Number(s): 3002N95-M, Lot Number 051130-161.
  • Manufacturer
    Inovel LLC

Manufacturer

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