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Class 2 Device Recall Welcon |
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Date Initiated by Firm |
January 20, 2011 |
Date Posted |
May 25, 2011 |
Recall Status1 |
Terminated 3 on October 25, 2012 |
Recall Number |
Z-2257-2011 |
Recall Event ID |
58021 |
Product Classification |
Tray, catheterization, sterile urethral, with or without catheter - Product Code FCM
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Product |
Case Label: REORDER NO. 6121 STERILE WELCON BRAND 2-Piece 60cc BULB SYRINGE With Sterile Saline 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 6121 STERILE UNLESS OPENED OR DAMAGED nurse assist incorporated A6010, R1 WELCON BRAND SINGLE USE Bulb Irrigation Tray With 100 mL Sterile Saline 0.9% 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CONTENTS: 1200 mL Graduated Drain Tray 100 mL Sterile Saline 0.9% 60cc Bulb Syringe Protective Cap Prep Pad Waterproof Underpad
Intended use: The trays are irrigation trays for catheters |
Code Information |
Lot Code: 902288 and 1003392 |
Recalling Firm/ Manufacturer |
Nurse Assist, Inc 3400 Northern Cross Blvd Fort Worth TX 76137-3600
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For Additional Information Contact |
817-231-1300 Ext. 14
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Manufacturer Reason for Recall |
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.
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FDA Determined Cause 2 |
Other |
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. |
Quantity in Commerce |
80 cases |
Distribution |
Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia. |
Total Product Life Cycle |
TPLC Device Report
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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.
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