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U.S. Department of Health and Human Services

Class 2 Device Recall WELCON TM BRAND

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  Class 2 Device Recall WELCON TM BRAND see related information
Date Initiated by Firm September 02, 2011
Date Posted January 11, 2012
Recall Status1 Terminated 3 on October 26, 2012
Recall Number Z-0497-2012
Recall Event ID 60412
510(K)Number K830359  
Product Classification Catheter, urological - Product Code KOD
Product WELCON TM BRAND REORDER NO. 7304 (STERILE) FOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com

FOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe
Code Information Assembly ID 7304U. Lot Numbers: 901103, 902290, 903276, 909391, 911333, 1002120, 1003395, 1005314, 1009373. Pack Lot #s: 34453, 34743, 34915, 35853, 36302, 36614, 36763, 37162, 37673.  
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 2		 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 792 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 and Original Applicant = WELCON, INC.
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