BEUDAMED
    FDA Recall Terminated

    Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the intravenous administration of medications.

    Recall: Z-1600-2013 · Initiated June 7, 2013

    Recall

    Recall Number
    Z-1600-2013
    Event Number
    65365
    Firm
    Baxter Healthcare Corp. Route
    FEI Number
    1416980
    Product Code
    MEB
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    June 7, 2013
    Posted
    June 27, 2013
    Terminated
    June 4, 2014
    Address
    120 And Wilson Rd, Round Lake, IL, 60073-9799

    Description

    Brand Name: Infusor SV and LV Elastomeric Infusion Devices. 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.

    Action

    An Urgent Product Recall notification was sent to all affected consignees on 06/13/2013. The letter states the affected products, problem description, hazard involved and actions to be taken by customer/user, with contact information. The letter was accompanied by a Customer Reply Form and a table of Affected Product List. The recall notification instructs customers to segregate affected product and contact Baxter for instructions for return of product.

    Distribution

    Distributed Nationwide and in Puerto Rico.

    Quantity

    3,255,096 total