Events

Recall of Genairex

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

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
    56564
  • Event Risk Class
    Class 3
  • Event Number
    Z-2427-2010
  • Event Initiated Date
    2010-08-16
  • Event Date Posted
    2010-09-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-01-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=93983
  • 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
    Bag, Stomal - Product Code GDS
  • Reason
    The product may contain the mold aspergillus ssp.
  • Action
    Biomed Laboratories, Inc. of Garland, TX is conducting a recall of the Reliamed Odor Eliminator Drops, Securi-T Ostomy Deodorant, and the Safe n' Simple (Sn'S) Ostomy Appliance Deodorant. Lots being recalled were distributed between June 9, 2009 though June 28, 2010. Biomed will work with their 3 consignees to inform sub-distributors and down to any firm that keeps the product in stock to have the product removed from further distribution and returned. If there are any questions or concerns, please contact Biomed Laboratories, Inc. at (972) 282-8008 or email them at biomedlabs.net.

Device

Genairex
  • Model / Serial
    Securi-T Ostomy Deodorant, 8 oz  Part # 108000, UPS Code 81164000810 Lots: E10051
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    OH, FL, MI
  • Product Description
    Genairex Securi-T Ostomy Deodorant || (8 oz, 1 oz package sizes)
  • Manufacturer
    BioMed Laboratories

Manufacturer

BioMed Laboratories
  • Manufacturer Address
    BioMed Laboratories, 2414 Executive Dr # 102, Garland TX 75041-6123
  • Manufacturer Parent Company (2017)
    BioMed Laboratories
  • Source
    USFDA