Class 2 Device Recall WELCON TM BRAND

• Date Initiated by Firm: September 02, 2011
• Date Posted: January 11, 2012
• Recall Status: Terminated on October 26, 2012
• Recall Number: Z-0499-2012
• Recall Event ID: 60412
• 510(K)Number: K830359
• Product Classification: Catheter, urological - Product Code KOD
• Product: WELCON TM BRAND REORDER NO. 7401 (STERILE) URETHRAL CATHETER KIT With 3 Compartment Plastic Pouch. LOT 25 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com URETHRAL CATHETER KIT With 3 Compartment Plastic Pouch
• Code Information: Assembly ID 7401U. Lot Numbers: 812079, 902097, 902277, 903269, 906271, 908068, 908308, 910048, 912364, 1002116, 1003113, 1003387, 1010134. Pack Lot #s: 34545, 34915, 34743, 34915, 35317, 35560, 35683, 35853/35995, 36302, 36614, 36763, 36763, 36763.
• Recalling Firm/ Manufacturer: Nurse Assist, Inc; 3400 Northern Cross Blvd; Fort Worth TX 76137-3600
• For Additional Information Contact: William Kanewske; 800-649-6800
• Manufacturer Reason for Recall: 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.
• FDA Determined Cause: Component design/selection
• 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.
• Quantity in Commerce: 1765 cases
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Canada and Saudi Arabia.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = KOD