BEUDAMED
    FDA Recall Terminated

    Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.

    Recall: Z-2661-2014 · Initiated September 4, 2014

    Recall

    Recall Number
    Z-2661-2014
    Event Number
    69182
    Firm
    Teleflex Medical
    FEI Number
    3005747797
    Product Code
    KOD
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    September 4, 2014
    Posted
    September 18, 2014
    Terminated
    February 22, 2017
    Address
    2917 Weck Dr, Research Triangle Park, NC, 27709-0186

    Description

    Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.

    Reason

    Misbranding: Although the product labeling identifies the catheters as "soft rubber," the Natural Rubber Latex caution statement was not printed on the product label.

    Action

    Consignees were notified via letter on/about 09/04/2014. Subsequently, consignees were notified of the expanded recall on 01/13/2015.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Bahrain, Belgrad, Canada, Croatia, Cypress, Czeck Republic, Denmark, Finland, Germany, Great Britain, Hungary, Ireland, Italy, Libya, Netherlands, Norway, Romania, Russia, Saudi Arabia, Slavonia, Slovakia, Spain, Switzerland, Turkey, Portugal and Zambia.

    Quantity

    193,363 ea. + 1,140 units (total 194,503 units)