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U.S. Department of Health and Human Services

Class 2 Device Recall Welcon

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  Class 2 Device Recall Welcon see related information
Date Initiated by Firm January 20, 2011
Date Posted May 25, 2011
Recall Status1 Terminated 3 on October 25, 2012
Recall Number Z-2255-2011
Recall Event ID 58021
Product Classification Tray, catheterization, sterile urethral, with or without catheter - Product Code FCM
Product REORDER NO. 6111 STERILE WELCON BRAND 60cc BULB SYRINGE With Sterile Water 20 ea/Box nurse assist incorporated 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com

Intended use: The trays are irrigation trays for catheters
Code Information Lot Code:
Recalling Firm/
Manufacturer		 Nurse Assist, Inc
3400 Northern Cross Blvd
Fort Worth TX 76137-3600
For Additional Information Contact
817-231-1300 Ext. 14
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.
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.
Distribution Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai 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.
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