BEUDAMED
    FDA Recall Terminated

    Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.

    Recall: Z-2395-2012 · Initiated August 28, 2012

    Recall

    Recall Number
    Z-2395-2012
    Event Number
    63078
    Firm
    Hospira Inc.
    FEI Number
    3013319212
    Product Code
    KPE
    Status
    Terminated
    Root Cause
    Material/Component Contamination
    Initiated
    August 28, 2012
    Posted
    September 17, 2012
    Terminated
    September 18, 2013
    Address
    275 N Field Dr, Lake Forest, IL, 60045-2579

    Description

    Empty Evacuated Container 250 mL and 1000 mL. Empty Evacuated containers are used for mixing compatible medications or blood collections.

    Reason

    Embedded iron oxide glass defect which may have the potential to break off into the solution.

    Action

    Hospira sent an "URGENT DEVICE RECALL" dated August 28, 2012 to all affected customers. The letter identified the product, problem,and actions to be taken by the customers. The letter included an Urgent Device Recall Reply Form for customers to complete and return via fax to 1-888-237-5582. Contact Hospira Customer Care at 1-877-946-7747 for questions regarding this recall.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Saudi Arabia, Canada and Barbados.

    Quantity

    191,094 units