BEUDAMED
    FDA Recall Terminated

    SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.

    Recall: Z-2738-2014 · Initiated September 3, 2014

    Recall

    Recall Number
    Z-2738-2014
    Event Number
    69122
    Firm
    Baxter Healthcare Corp.
    FEI Number
    1416980
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    September 3, 2014
    Posted
    October 1, 2014
    Terminated
    March 16, 2017
    Address
    25212 W. Illinois Route 120, Round Lake, IL, 60073-9799

    Description

    SPECTRUM Pump, Model No. 35700BAX. Intended to be used for the controlled administration of intravenous fluids.

    Reason

    One Service Technician may not have correctly serviced specific Sigma Spectrum Infusion Pumps according to established procedures during the time period of 5/5/2014 through 6/3/2014.

    Action

    Initial notification was initiated via telephone call by the Baxter Medina Service Center on 8/28/14 to all affected Sigma SPECTRUM Infusion Pump consignees. URGENT DEVICE CORRECTION Letters (dated 9/03/2014) were sent to the consignees via USPS first class mail on 9/03/14 formally informing them of the recall. The letters identified the affected product, the description of the issue, the hazard involved, as well as, the actions to be taken by customer. Customers are being instructed to immediately remove the pump from use and return the pump to Baxter for inspection. The firm will provide replacements. Customers are to contact Baxter Healthcare Medina at 800-356-3454 for technical questions regarding the letter.

    Distribution

    Worldwide Distribution -- USA and Canada.

    Quantity

    USA: 56 units, Canada: 2 units