BEUDAMED
    FDA Enforcement Class II Terminated

    Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications.

    Recall: Z-1606-2013 · Reported July 3, 2013

    Enforcement

    Recall Number
    Z-1606-2013
    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: Basal/Bolus Infusor. 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: 2C1955KJP, 2C1976KJ Lot Codes: 08K006 08M038 08N001 09C021 09E028 09F078 09H080 09J046 09M052 09N030 09N048 10A043 108023 10E054 10H055 10J031 10K050 10M085 10N026 09H033 10B028 10B081 10E004 10J106 Expiration Dates: 06/30/15, 12/31/14, 12/31/15, 06/30/14, 12/31/14

    Distribution

    Distributed Nationwide and in Puerto Rico.

    Quantity

    3,255,096 total