Events

Recall of WELCON TM BRAND

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Nurse Assist, 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
    60412
  • Event Risk Class
    Class 2
  • Event Number
    Z-0494-2012
  • Event Initiated Date
    2011-09-02
  • Event Date Posted
    2012-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=106001
  • 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
    Catheter, urological - Product Code KOD
  • Reason
    Nurse assist, inc. received a recall notice from the triad group. this recall has been initiated due to a recall of the pvp solution packs manufactured by the triad group that are contained in certain procedure trays.
  • Action
    Nurse Assist sent a recall notice dated September 2, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately and quarantine the affected product. Customers were also instructed to identify their customers and notify them at once of the product recall. Customers were instructed to complete and return the enclosed response form as soon as possible. For those distributors that choose to destroy the affected product they must use the attached Notice of Destruction to report the specifics of the destroyed product. and contact Nurse Assist Customer Service for a RGA # prior to destruction. For any questions call Nurse Assist Customer Service at 1-800-649-6800.

Device

WELCON TM BRAND
  • Model / Serial
    Assembly ID 7301U. Lot Numbers: 902289, 903275, 904256, 906199, 908220, 909287, 911230, 1001029, 1001321, 1002313, 1004171, 1005313, 1006205, 1007080, 1008316, 1009277. Pack Lot #s: 34743, 34915, 35207, 35317, 35683, 35853/35995, 36146, 36467, 36467, 36614/36763, 36903, 37026, 37162, 37400, 37400/37655, 37673.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and the countries of Canada and Saudi Arabia.
  • Product Description
    WELCON TM BRAND REORDER NO. 7301 (STERILE) URETHRAL CATHETER TRAY w/ Plastic Catheter 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com || Urethral Catheter Tray with Plastic Catheter
  • Manufacturer
    Nurse Assist, Inc

Manufacturer

Nurse Assist, Inc
  • Manufacturer Address
    Nurse Assist, Inc, 3400 Northern Cross Blvd, Fort Worth TX 76137-3600
  • Manufacturer Parent Company (2017)
    Nurse Assist Inc.
  • Source
    USFDA