BEUDAMED
    FDA Enforcement Class II Terminated

    Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications.

    Recall: Z-1602-2013 · Reported July 3, 2013

    Enforcement

    Recall Number
    Z-1602-2013
    Event ID
    65365
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 3, 2013
    Initiation Date
    June 7, 2013
    Classification Date
    June 27, 2013
    Termination Date
    June 4, 2014
    Address
    Route 120 And Wilson Rd, Round Lake, IL, 60073-9799, United States

    Description

    Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications.

    Reason

    Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.

    Code Info

    Product Codes: 2C1154KP, 2C1155KP, 2C9960KP, 2C9961KP Lot Numbers: 10F030 10F066 10H043 10H104 10K027 10K099 10M090 10G028 10J059 10M019 10M089 10F058 10G069 10G042 10J048 10M026 Expiration Date: 06/30/13

    Distribution

    Distributed Nationwide and in Puerto Rico.

    Quantity

    3,255,096 total