BEUDAMED
    FDA Recall Terminated

    Latex Free*** REF B1000P Belly Bag Urine Collection Bag with Sample Port***1000 ml LOT***Sterile EO*** Single use only, Manufactured and Distributed by***Rusch Inc., 245 Meadowbrook Parkway, Duluth, GA 30096***Quantity 10****

    Recall: Z-0648-05 · Initiated May 13, 2004

    Recall

    Recall Number
    Z-0648-05
    Event Number
    31009
    Firm
    Teleflex Medical, Inc.
    FEI Number
    2429473
    Product Code
    KNX
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 13, 2004
    Posted
    March 23, 2005
    Terminated
    August 31, 2009
    Address
    2450 Meadowbrook Pkwy, Duluth, GA, 30096-4635

    Description

    Latex Free*** REF B1000P Belly Bag Urine Collection Bag with Sample Port***1000 ml LOT***Sterile EO*** Single use only, Manufactured and Distributed by***Rusch Inc., 245 Meadowbrook Parkway, Duluth, GA 30096***Quantity 10****

    Reason

    Firm received complaints of leaking urine collection bags.

    Action

    Consignees were notified by letter on 5/13/2004. A follow up letter was sent on 11/22/2004.

    Distribution

    Nationwide, Australia, Japan and the UK

    Quantity

    1227 bags