BEUDAMED
    FDA Enforcement Class II Terminated

    Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used with the Pharm-Assist Dispensing Pump. Used for drug reconstitution and/or fluid transfer

    Recall: Z-2070-2014 · Reported July 23, 2014

    Enforcement

    Recall Number
    Z-2070-2014
    Event ID
    68573
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Excelsior Medical Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 23, 2014
    Initiation Date
    June 5, 2014
    Classification Date
    July 16, 2014
    Termination Date
    August 19, 2015
    Address
    1933 Heck Ave, N/A, Neptune, NJ, 07753, United States

    Description

    Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Triple Lead Tubing Set. To be used with the Pharm-Assist Dispensing Pump. Used for drug reconstitution and/or fluid transfer

    Reason

    There is a potential for a leak. A molding defect in the connector that joins the three leads to the main flow line may allow fluid to escape or air to enter the fluid path during transfer of fluids from one container to another.

    Code Info

    Product Code PA03 - Lot Nos.: 03030813, 03050813 and 03091213 Product Code BX03, Lot Nos.: 64031513, 64073113, 64081313, 64090513

    Distribution

    Worldwide Distribution - USA (nationwide) and Canada.

    Quantity

    4250 tubing sets (PA03 - 78 cases; BX03 - 92 cases (each case contains 25 tubing sets))