BEUDAMED
    FDA Enforcement Class II Terminated

    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC 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. Non-Valve lumens are indicated for central venous pressure monitoring.

    Recall: Z-0251-2018 · Reported December 20, 2017

    Enforcement

    Recall Number
    Z-0251-2018
    Event ID
    76570
    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 20, 2017
    Initiation Date
    November 28, 2016
    Classification Date
    December 13, 2017
    Termination Date
    June 12, 2019
    Address
    10 Glens Falls Tech Park, N/A, Glens Falls, NY, 12801-3864, United States

    Description

    Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved w/ Nit GW, UPN H965458950, Catalog No. 45-895 The Xcela with PASV, BioFlo PICC with ENDEXO Technology, and BioFlo PICC 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. Non-Valve lumens are indicated for central venous pressure monitoring.

    Reason

    Navilyst Medical, Inc. (NMI) the manufacturer of the Xcela PICC with PASV, BioFlo PICC with PASV and the BioFlo PICC, conducted this recall to the end user level based on information received from Greatbatch Medical, the manufacturer of the ViaPeel PTFE Peelable Introducer. Greatbatch Medical determined that the products listed in their 11/11/2016 Recall Notification have the potential for the handles to detach from the sheath during use. NMI has confirmed that the affected sheaths, Greatbatch Model Number 10890-006, had been included in packaged Xcela and BioFlo PICC Kits.

    Code Info

    Lot 4902618

    Distribution

    Worldwide Distribution: US (Nationwide) and countries of:; Canada, Great Britain, Netherlands, South Australia and Spain.

    Quantity

    4591 units in total