BEUDAMED
    FDA Recall Terminated

    The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinician programmed and/or hospital defined medication limits.

    Recall: Z-1518-2015 · Initiated February 27, 2013

    Recall

    Recall Number
    Z-1518-2015
    Event Number
    64225
    Firm
    Hospira Inc.
    FEI Number
    3013319212
    Product Code
    MEA
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 27, 2013
    Posted
    April 23, 2015
    Terminated
    November 7, 2016
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579

    Description

    The LifeCare PCA infusion system with Hospira MedNet software allows clinicians, or patients, to (self) Administer analgesia within clinician programmed and/or hospital defined medication limits.

    Reason

    The infusion pump has a clear plastic door that, due to its design, allows for excessive flexing. This in turn permits unauthorized access to the vial of medication.

    Action

    Hospira will contract with Stericycle Inc., in Indianapolis, IN to send letters and a reply form to Hospira customers. Receipt of the letters will be confirmed by the UPS tracking. Customers will be requested to return a reply form to Stericycle indicating the number of pumps on hand and that they have received the letter and notified the users. For questions regarding this recall call 800-441-4100.

    Distribution

    Worldwide Distribution - US including AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, District of Columbia, Puerto Rico, American Virgin Islands; and Internationally to Canada.

    Quantity

    38,882