Events

Recall of Device Recall WELCON

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
    58021
  • Event Risk Class
    Class 2
  • Event Number
    Z-2251-2011
  • Event Initiated Date
    2011-01-20
  • Event Date Posted
    2011-05-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-10-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=98170
  • 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
    Tray, catheterization, sterile urethral, with or without catheter - Product Code FCM
  • Reason
    The irrigation procedure trays contain triad group alcohol prep pads recalled by triad group because they have the potential to be contaminated with an objectionable organism.
  • Action
    The firm, Nurse Assist Incorporated, sent a letter dated January 20, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory immediately; quarantine the product; identify their customers and notify them at once about the product recall (Nurse Assist will provide bright labels to affix to your affected inventory); provide their customers with labels as well, and complete and return the attached RECALL ACKNOWLEGEMENT form via fax to: 817-231-1500 or mail to: Nurse Assist, Inc., 3400 Northern Cross Blvd., Forth Worth, TX 76137. Only the product and lots identified on the attached list are affected. If you have any questions or to request labels, please call Nurse Assist Customer Service Monday through Friday, from 8:00 am to 5:00 pm Central Time at 1-800-649-6800.

Device

Device Recall WELCON
  • Model / Serial
    Lot codes: 812083, 901041, 904254, 907192, 908039, 911228, 912190, 1003293, 1004168, and 1005018
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
  • Product Description
    Case Label: REORDER NO. 6101 STERILE WELCON BRAND Standard Irrigation Tray Clear-Vu Bulb Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com || Product Label: REORDER NO. 6101 STERILE UNLESS OPENED OR DAMAGED nurse assist incorporated A6031, R1 WELCON BRAND SINGLE USE Standard Irrigation Tray With Clear-Vu Bulb Syringe 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com LatexFree CONTENTS: 1200 mL Graduated Drain Tray 500 mL Graduate Bulb Syringe Waterproof Underpad Prep Pad Protective Cap || Intended use: The trays are irrigation trays for catheters
  • 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