BEUDAMED
    FDA Recall Terminated

    Case Label: REF UT1001 Irrigation Tray with 60 cc Bulb Syringe Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Tray Label: Cysto-Care Coloplast Irrigation Tray with 60 cc Bulb Syringe Contents 1200 cc graduated drain tray 500 cc graduated container 60 cc bulb syringe Waterproof underpad Alcohol wipe For Rx Only Sterile unless packaged is damaged or opened. Latex Free REF: UT1001 Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Assembled in USA Intended use: The trays are irrigation trays for catheters

    Recall: Z-2259-2011 · Initiated January 20, 2011

    Recall

    Recall Number
    Z-2259-2011
    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: REF UT1001 Irrigation Tray with 60 cc Bulb Syringe Qty: 20 For Rx Only Sterile unless package is damaged or opened. Latex Free Manufactured for: Coloplast A/S 3050 Denmark STERILE EO Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 Tray Label: Cysto-Care Coloplast Irrigation Tray with 60 cc Bulb Syringe Contents 1200 cc graduated drain tray 500 cc graduated container 60 cc bulb syringe Waterproof underpad Alcohol wipe For Rx Only Sterile unless packaged is damaged or opened. Latex Free REF: UT1001 Manufactured for: Coloplast A/S 3050 Denmark Distributed by: Coloplast Corp. Minneapolis, MN 55411 USA 1-800-328-3863 STERILE EO Assembled in USA 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

    3120 cases