Events

Recall of Device Recall Porex Nostril Retainers

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Porex Surgical, 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
    36172
  • Event Risk Class
    Class 3
  • Event Number
    Z-1515-06
  • Event Initiated Date
    2006-07-11
  • Event Date Posted
    2006-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-02-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=48124
  • 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
    Nostril retainers - Product Code LYA
  • Reason
    Device contains a trace amount of amine via introduction through an intermediate supplied by a third party raw material.
  • Action
    Consignees were contacted by phone for product return and with a follow up in letter dated 07/12/2006.

Device

Device Recall Porex Nostril Retainers
  • Model / Serial
    Catalog number 7241-Lot number B002E05N
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide distribution ---- including states of AZ, CA, CT, DC, FL, NC, PA, WI and country of Germany. AZ, CA, CT, DC, FL, NC, PA, WI and Germany
  • Product Description
    Porex Nostril Retainers, CAT #7241, Size 4, Porex Surgical Inc., 15 Dart Road, Newnan, GA 30265 USA.
  • Manufacturer
    Porex Surgical, Inc.

Manufacturer

Porex Surgical, Inc.
  • Manufacturer Address
    Porex Surgical, Inc., 15 Dart Rd, Newnan GA 30265-1017
  • Source
    USFDA