BEUDAMED
    FDA Enforcement Class II Terminated

    Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use in attaining long term vascular access for hemodialysis and apheresis in adult patients.

    Recall: Z-2592-2014 · Reported September 10, 2014

    Enforcement

    Recall Number
    Z-2592-2014
    Event ID
    68993
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medical Components, Inc dba MedComp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 10, 2014
    Initiation Date
    August 4, 2014
    Classification Date
    September 4, 2014
    Termination Date
    December 10, 2014
    Address
    1499 Delp Dr, Harleysville, PA, 19438, United States

    Description

    Split Cath III Trays, 16F x 28CM Product Usage: The Split Cath III is indicated for use in attaining long term vascular access for hemodialysis and apheresis in adult patients.

    Reason

    The Split Cath III Trays were incorrectly labeled as 16F x 32CM Split Cath III instead of 28CM.

    Code Info

    TRAY #55216-3; Lot numbers: MBTX960, exp. 10/2016; MBVA850, exp. 10/2016; MBVD080, exp. 01/2017; MBVG680, exp. 01/2017; MBVL020, exp. 01/2017.

    Distribution

    USA Nationwide Distribution

    Quantity

    110