BEUDAMED
    FDA Recall Terminated

    REF UT7030 Catheter Insertion Tray 30cc Pre-Filled Syringe with PVP Swabs 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 Distribue par: Coloplast Canada Corporation 3300 Ridgeway Drive Unit 12 Mississauga, Ontario Canada L5L 5Z9 1-905-820-7588 Catheter Insertion Tray 30cc Pre-Filled Syringe with PVP Swabs

    Recall: Z-0503-2012 · Initiated September 2, 2011

    Recall

    Recall Number
    Z-0503-2012
    Event Number
    60412
    Firm
    Nurse Assist, Inc
    FEI Number
    3002695476
    Product Code
    KOD
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    September 2, 2011
    Posted
    January 11, 2012
    Terminated
    October 26, 2012
    Address
    3400 Northern Cross Blvd, Fort Worth, TX, 76137-3600

    Description

    REF UT7030 Catheter Insertion Tray 30cc Pre-Filled Syringe with PVP Swabs 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 Distribue par: Coloplast Canada Corporation 3300 Ridgeway Drive Unit 12 Mississauga, Ontario Canada L5L 5Z9 1-905-820-7588 Catheter Insertion Tray 30cc Pre-Filled Syringe with PVP Swabs

    Reason

    Nurse Assist, Inc. received a recall notice from the Triad Group. This recall has been initiated due to a recall of the PVP Solution Packs manufactured by the Triad Group that are contained in certain procedure trays.

    Action

    Nurse Assist sent a recall notice dated September 2, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory immediately and quarantine the affected product. Customers were also instructed to identify their customers and notify them at once of the product recall. Customers were instructed to complete and return the enclosed response form as soon as possible. For those distributors that choose to destroy the affected product they must use the attached Notice of Destruction to report the specifics of the destroyed product. and contact Nurse Assist Customer Service for a RGA # prior to destruction. For any questions call Nurse Assist Customer Service at 1-800-649-6800.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Canada and Saudi Arabia.

    Quantity

    4312 CASES