BEUDAMED
    FDA Enforcement Class II 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 · Reported March 27, 2013

    Enforcement

    Recall Number
    Z-0969-2013
    Event ID
    64471
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Molded Products Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 27, 2013
    Initiation Date
    June 19, 2012
    Classification Date
    March 18, 2013
    Termination Date
    August 14, 2013
    Address
    1112 Chatburn Ave, N/A, Harlan, IA, 51537-2007, United States

    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.

    Code Info

    Lot numbers: 80106 and 80106b

    Distribution

    Distributed to one customer in Michigan.

    Quantity

    1200 sets