BEUDAMED
    FDA Recall 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 · Initiated August 2, 2012

    Recall

    Recall Number
    Z-2346-2012
    Event Number
    62909
    Firm
    Hospira, Inc.
    FEI Number
    3013319212
    Product Code
    MEA
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 2, 2012
    Posted
    September 10, 2012
    Terminated
    May 8, 2014
    Address
    600 N Field Dr, Bldg J45, Lake Forest, IL, 60045

    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.

    Action

    Hospira sent an Urgent Device Field Correction letter dated August 3, 2012, to all affected customers. The letter identifed the product, the probem, and the action to be taken by the customer. Customers were instructed to first consider the use of Prefilled Morphine PCA Vials wherever possible. In some instances, the treating physician may require an alternative to morphine. Customers may continue using the affected product by following the instructions provided in the Correction Letter. Customers were asked to complete the attached Reply Form and fax it to 1-888-879-8144. For questions regarding this recall call 877-946-7747.

    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