Events

Recall of Ear/Ulcer Bulb Syringe

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medegen Medical Products, 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
    26196
  • Event Risk Class
    Class 2
  • Event Number
    Z-0860-03
  • Event Initiated Date
    2003-04-30
  • Event Date Posted
    2003-05-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-11-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=27244
  • 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
    Syringe, Ent - Product Code KCP
  • Reason
    Finished products were not sterilized.
  • Action
    Medegen has notified all direct accounts by certified mail on 4/30/03.

Device

Ear/Ulcer Bulb Syringe
  • Model / Serial
    Catalog # 4173, Lot number 038594A1.
  • Product Classification
    Ear, Nose, and Throat Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide domestic distribution. Foreign distribution to Canada and Saudia Arabia. No government and military consignees.
  • Product Description
    GENT-L-KARE Sterile 3OZ. EAR/ULCER BULB SYRINGE SINGLE USE
  • Manufacturer
    Medegen Medical Products, LLC

Manufacturer

Medegen Medical Products, LLC
  • Manufacturer Address
    Medegen Medical Products, LLC, 11060 Irma Drive, Northglenn CO 80233
  • Source
    USFDA