BEUDAMED
    FDA Recall Terminated

    Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device Device Listing: D020871 Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate.

    Recall: Z-1609-2013 · Initiated June 7, 2013

    Recall

    Recall Number
    Z-1609-2013
    Event Number
    65364
    Firm
    Baxter Healthcare Corp. Route
    FEI Number
    1416980
    Product Code
    MEB
    Status
    Terminated
    Root Cause
    Device Design
    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: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device Device Listing: D020871 Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients requiring slow, continuous intravenous, intra-arterial, subcutaneous, or epidural administration of medications at a constant flow rate.

    Reason

    Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer.

    Action

    Baxter sent an Urgent Produd Recall notification letter dated June 13, 2013, to all affected consignees via USPS. The letter was accompanied by a Customer Reply Form and Affected Product List (table). The letter stated affected products, problem description, risk to health (or health risks), actions to be taken by customers/users and contact information. The recall notification instructs customers to segregate affected product from current inventory and contact Baxter for instructions to return affected product. Customers with questions were instructed to call Baxter at 1-800-437-5176, For questions regarding this recall call 847-270-5556.

    Distribution

    Worldwide Distribution - USA (nationwide), Puerto Rico, and Internationally to Brazil, Colombia, Panama, Mexico, Singapore Japan, Australia, New Zealand, Hong Kong, India, Thailand, Taiwan, and Korea.

    Quantity

    601,230 total