BEUDAMED
    FDA Enforcement Class II Terminated

    BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media

    Recall: Z-0710-2017 · Reported December 14, 2016

    Enforcement

    Recall Number
    Z-0710-2017
    Event ID
    75322
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Angiodynamics Inc. (Navilyst Medical Inc.)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 14, 2016
    Initiation Date
    August 29, 2016
    Classification Date
    December 5, 2016
    Termination Date
    June 15, 2018
    Address
    10 Glens Falls Tech Park, N/A, Glens Falls, NY, 12801-3864, United States

    Description

    BioFlo PICC with ENDEXO and PASV Valve Technology Maximal Barrier Nursing Kit - UPN # H965750191/Catalog No:75-019 The BioFlo PICCs with ENDEXO and PASV Valve Technology are indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, nutrients; the sampling of blood; and for power injection of contrast media

    Reason

    Medline Industries, Inc. supplies Navilyst with sterile package gloves included in the tandem packing of the Maximal Barrier Nursing Kits. Medline has determined that specific lots of the gloves supplied to Navilyst contain an incorrect expiration date. Navilyst has confirmed that Medlines affected sterile gloves (Medline Part Number MSG1075/MSG3075) have been included in a limited number of kits.

    Code Info

    Batch/Lot: 5018263, 5020646, 5046472, 5051539

    Distribution

    Nationwide Distribution including AZ, CA, FL, GA, HI, IL< IN< KS, LA, MI, MN, MO, ND, NM, OH, OR, PA, TN, TX, WA & the District of Columbia.

    Quantity

    200 packages (boxes of 5)