BEUDAMED
    FDA Recall Terminated

    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

    Recall: Z-2257-2011 · Initiated January 20, 2011

    Recall

    Recall Number
    Z-2257-2011
    Event Number
    58021
    Firm
    Nurse Assist, Inc
    FEI Number
    3002695476
    Product Code
    FCM
    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. 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

    Reason

    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.

    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

    80 cases