BEUDAMED
    FDA Recall Terminated

    Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.

    Recall: Z-0113-2015 · Initiated August 28, 2014

    Recall

    Recall Number
    Z-0113-2015
    Event Number
    69204
    Firm
    Vygon Corporation
    FEI Number
    2245270
    Product Code
    FOZ
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    August 28, 2014
    Posted
    October 22, 2014
    Terminated
    March 30, 2015
    Address
    2750 Morris Rd, Ste A200, Lansdale, PA, 19446-6083

    Description

    Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.

    Reason

    Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector.

    Action

    Vygon sent an Urgent Medical Device Recall letter dated August 28, 2014, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their stock for the affected product and immediately cease distribution, and quarantine all affected product immediately. Count and document the affected inventory on the "Recall Acknowledgement and Inventory Return Form. Customers were asked to fax or email the form to Vygon including customer contact information. Vygon customer service will contact the customer and issue a Return Merchandise Authorization number. Customers were instructed to return the product as well as the original signed Recall Acknowledgement and Inventory Return Form using the instructions from Customer Service involving product pick-up. All inventory will be credited at no cost to the customer. For questions regarding this recall call 800-473-5414.

    Distribution

    Worldwide Distribution - US including CA and Internationally to CA.

    Quantity

    42250