BEUDAMED
    FDA Enforcement Class II Terminated

    Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications.

    Recall: Z-1603-2013 · Reported July 3, 2013

    Enforcement

    Recall Number
    Z-1603-2013
    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: Intermate Infusion Pump. 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: 2C1064K Lot Codes: 10F007 10F077 10H075 10J097 10K076 10K112 10M062 Expiration Date: 06/30/13

    Distribution

    Distributed Nationwide and in Puerto Rico.

    Quantity

    3,255,096 total