BEUDAMED
    FDA Recall Terminated

    Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure Limited Check Valve, 3 Ultrasite Injection Sites, Backcheck Valve, and Spin-Lock Connector, Catalog # 352520. For use with the Horizon NXT Pump, and OutLook Safety Infusion System.

    Recall: Z-1428-2009 · Initiated March 27, 2009

    Recall

    Recall Number
    Z-1428-2009
    Event Number
    51869
    Firm
    B. Braun Medical, Inc.
    FEI Number
    2523676
    Product Code
    FPA
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    March 27, 2009
    Posted
    June 5, 2009
    Terminated
    December 15, 2009
    Address
    901 Marcon Boulevard, Allentown, PA, 18109-9512

    Description

    Ultrasite IV Set for Outlook Safety Infusion System with Universal Spike, Pressure Limited Check Valve, 3 Ultrasite Injection Sites, Backcheck Valve, and Spin-Lock Connector, Catalog # 352520. For use with the Horizon NXT Pump, and OutLook Safety Infusion System.

    Reason

    Device defect is occlusion/no flow.

    Action

    An Urgent - Medical Device Recall notice was issued via US Postal Service Certified Mail with registered return receipt mail or FedEx to all customer/distributors in receipt of affected product on 3/27/09. Direct customers received letters addressed to Materials Management that informed them of this recall and provided instructions for disposition of affected product in their inventory. Distributors received the direct customer recall letter along with a cover letter outlining their responsibilities to execute the recall and notify their customers as requested. Distributors are to immediately discontinue further distribution of the affected product, determine their customers' inventory, and have their customers return the product to them. The attached "Product Removal Acknowledgement" should be used to indicate the specifics of the combined distributor and customer inventories. The Customer Support Department should be contacted to arrange for return. A Customer Support Representative will provide instructions for handling the affected product and assist with replacement product.

    Distribution

    Worldwide Distribution -- USA and Canada.

    Quantity

    13,008 units