BEUDAMED
    FDA Enforcement Class I Terminated

    Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.

    Recall: Z-1482-2014 · Reported May 7, 2014

    Enforcement

    Recall Number
    Z-1482-2014
    Event ID
    67591
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hospira Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 7, 2014
    Initiation Date
    October 31, 2013
    Classification Date
    May 1, 2014
    Termination Date
    August 16, 2017
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579, United States

    Description

    Abbott Acclaim Infusion Pump Designed to deliver parenteral infusions including whole blood or red blood cell components and enteral fluids using a wide variety of standard administration sets and fluid containers.

    Reason

    Hospira has received customer reports of broken door assemblies on the Hospira/Abbott Acclaim Encore infusion pumps. If the door assembly breaks, it may prevent the door from closing properly and unrestricted flow may occur. If the door cannot be closed, the pump cannot be used which can result in a delay in therapy.

    Code Info

    List Number: 12032; Serial Numbers: 12322921, 12323859, 12322780, 12322801, 12322810, 12322812, 12322878, 12322880, 12322887, 12322896, 12322903, 12322904, 12322911, 12322917, 12322936, 12322939, 12323867, 12322916, 12323056, 12321139, 12324767, 12324854, 12324802, 12322873, 12324375, 1231453, 1231610.

    Distribution

    Nationwide Distribution -- AK, AL, AR, AZ, CA, CO, CR, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.

    Quantity

    13,218 infusion pumps total