Case Label: REORDER NO. 7302 (STERILE) WELCON BRAND URETHRAL CATHETER TRAY w/Red Rubber Catheter Caution: Contains Natural Latex nurse assist incorporated 20 ea/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com MADE IN U.S.A. Tray Label: REORDER NO. 7302 STERILE UNLESS OPENED OR DAMAGED nurse assist incorporated A6002, R1 SINGLE USE WELCON BRAND Disposable Urethral Catheterization Tray With 14 Fr Red Rubber Catheter Including PVP Swabsticks 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com CONTENTS: Underpad Vinyl Gloves Fenestrated Drape Screw Top Specimen Container Lube Jelly 1200 mL Graduated Tray 14 Fr Red Rubber Catheter PVP Swabsticks Intended use: The trays are urological catheter trays.
FDA Recall Z-2272-2011 · Posted 2011-05-25
Advertisement
Recalling FirmNurse Assist, Inc
Recall StatusTerminated
Product CodeKOD
Date Initiated2011-01-20
Date Terminated2012-10-25
Product Quantity1,754
Reason for Recall
The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement