BEUDAMED
    FDA Enforcement Class II Terminated

    Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer.

    Recall: Z-1679-2017 · Reported April 5, 2017

    Enforcement

    Recall Number
    Z-1679-2017
    Event ID
    76760
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Molded Products Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 5, 2017
    Initiation Date
    January 20, 2015
    Classification Date
    March 24, 2017
    Termination Date
    March 30, 2017
    Address
    1112 Chatburn Ave, Harlan, IA, 51537-2007, United States

    Description

    Non-Sterile Double DIN to DIN "Y" Connector, Product Usage: Extension for connecting hemodialysis blood tubing to the hemodialyzer.

    Reason

    A customer relayed a complaint of a leaking dialysis tubing connector.

    Code Info

    40013

    Distribution

    Product was distributed to Ontario, Canada.

    Quantity

    400 pieces