BEUDAMED
    FDA Recall Terminated

    Case Label: REORDER NO. 7204 (STERILE) CSR WRAP WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe nurse assist incorporated 20 ex/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7204 SINGLE USE/STERILE UNLESS OPENED OR DAMAGED Accorde Foley Catheter Tray with 30ml Prefilled Syringe CONTENTS: CSR wrap Underpad Gloves Fenestrated drape Forceps PVP Solution Rayon balls in prep cup Specimen container and label Lube jelly Graduated tray 30ml Prefilled Syringe Another cost effective product from Welcon, Inc. Providence, RI 02909 Intended use: The trays are urological catheter trays.

    Recall: Z-2269-2011 · Initiated January 20, 2011

    Recall

    Recall Number
    Z-2269-2011
    Event Number
    58021
    Firm
    Nurse Assist, Inc
    FEI Number
    3002695476
    Product Code
    KOD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 20, 2011
    Posted
    May 25, 2011
    Terminated
    October 25, 2012
    Address
    3400 Northern Cross Blvd, Fort Worth, TX, 76137-3600

    Description

    Case Label: REORDER NO. 7204 (STERILE) CSR WRAP WELCON BRAND FOLEY CATHETER TRAY w/o Catheter w/30ml. Prefilled Syringe nurse assist incorporated 20 ex/Box 800-649-6800 3400 Northern Cross Blvd. Fort Worth, TX 76137 www.nurseassist.com Tray Label: REORDER NO. 7204 SINGLE USE/STERILE UNLESS OPENED OR DAMAGED Accorde Foley Catheter Tray with 30ml Prefilled Syringe CONTENTS: CSR wrap Underpad Gloves Fenestrated drape Forceps PVP Solution Rayon balls in prep cup Specimen container and label Lube jelly Graduated tray 30ml Prefilled Syringe Another cost effective product from Welcon, Inc. Providence, RI 02909 Intended use: The trays are urological catheter trays.

    Reason

    The trays contain Triad Group Sterile Lubricating Jelly packs recalled by Triad Group because of the possibility of inadequate sterilization.

    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.

    Quantity

    96 cases