BEUDAMED
    FDA Recall 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 · Initiated October 31, 2013

    Recall

    Recall Number
    Z-1482-2014
    Event Number
    67591
    Firm
    Hospira Inc.
    FEI Number
    3013319212
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    October 31, 2013
    Posted
    May 1, 2014
    Terminated
    August 16, 2017
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579

    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.

    Action

    URGENT MEDICAL DEVICE CORRECTION letters, dated October 31, 2013, were sent to all direct accounts. The letters identified the affected product, as well as the reason for recall, risk to health, and instructions for device users. Users are to inspect each Hospira/Abbott Acclaim Encore infusion pump for door handle cracks prior to programming a therapy by following the provided instructions. The letter also included instructions for recipients to ensure that all potential users in the facility are made aware of the safety notification and the recommended actions; and complete the attached reply form and return it to the fax number or e-mail address on the form. Customers are to contact Stericycle at 866-891-0586 (Monday - Friday, 8:00 AM - 5:00 PM ET) to obtain additional reply forms if needed. If the devices were further distributed, those customers should be notified and asked to contact Stericycle at 866-891-0586 (Monday - Friday, 8:00 AM - 5:00 PM ET) to receive a reply form. The letter reminds customers that Hospira is retiring the Acclaim Encore infusion pump and will no longer support them as of December 31, 2014.

    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