BEUDAMED
    FDA Enforcement Class II Terminated

    Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device.

    Recall: Z-2346-2012 · Reported September 19, 2012

    Enforcement

    Recall Number
    Z-2346-2012
    Event ID
    62909
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hospira, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 19, 2012
    Initiation Date
    August 2, 2012
    Classification Date
    September 10, 2012
    Termination Date
    May 8, 2014
    Address
    600 N Field Dr Bldg J45, N/A, Lake Forest, IL, 60045, United States

    Description

    Sterile Empty Vial and Injector (30mL PCA vial), Rx only, One/List No. 6021-03, Hospira, Inc., Lake Forest, IL 60045. For use with a compatible Hospira PCA pump set with injector and a compatible Hospira infusion device.

    Reason

    Reports of leaking during filling and administration.

    Code Info

    The letter was issued for all product presently in the field and product that will be released. Specific lot numbers were not indicated in the letter.

    Distribution

    Worldwide Distribution - USA including AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NE, NV, NH, NJ, NY, NC, NK, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, and WY and the countries of Canada, Costa Rica and the Virgin Islands.

    Quantity

    unknown