BEUDAMED
    FDA Recall Terminated

    Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.

    Recall: Z-0969-2013 · Initiated June 19, 2012

    Recall

    Recall Number
    Z-0969-2013
    Event Number
    64471
    Firm
    Molded Products Inc
    FEI Number
    1000138417
    Product Code
    KOC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 19, 2012
    Posted
    March 18, 2013
    Terminated
    August 14, 2013
    Address
    1112 Chatburn Ave, Harlan, IA, 51537-2007

    Description

    Sterile Access & Return Line Set, 36" Length, Part # UM-872-36. Intended for use with medically prescribed hemodialysis blood tubing.

    Reason

    The recalled product leaks at the connection site.

    Action

    The firm's one customer was notified of the recall by phone call on 5/8/2012. The customer returned the affected product once the replacement product was received.

    Distribution

    Distributed to one customer in Michigan.

    Quantity

    1200 sets