BEUDAMED
    FDA Enforcement Class II Terminated

    BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.

    Recall: Z-0076-2019 · Reported October 17, 2018

    Enforcement

    Recall Number
    Z-0076-2019
    Event ID
    80913
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Angiodynamics Inc. (Navilyst Medical Inc.)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 17, 2018
    Initiation Date
    July 24, 2018
    Classification Date
    October 5, 2018
    Termination Date
    May 17, 2019
    Address
    10 Glens Falls Tech Park, Glens Falls, NY, 12801-3864, United States

    Description

    BioFlo Port with ENDEXO and PASV Technology-AngioDynamics BIOFLO 8F SINGLE PLASTIC NON-FILLED; VALVED PG UPN: H965440210 Catalog Number: 44-021 Box of 1 Port - Product Usage - Long-term access to the central venous system for administration of fluids including but not limited to hydration fluids, chemotherapy, analgesics, nutritional therapy and blood products. The device is also indicated for blood specimen withdrawal.

    Reason

    BioFlo Ports was partially manufactured with the incorrect sterile port assembly. The actual sterile port assembly used was, 8F SL Xcela Plus Titanium Valved Non-Filled, when it should have been, 8F SL BioFlo Plastic Valved Non-Filled

    Code Info

    Lot Number: 5363172

    Distribution

    US Nationwide in the state of IN.

    Quantity

    1 box