BEUDAMED
    FDA Enforcement Class II Terminated

    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801

    Recall: Z-0030-2015 · Reported October 15, 2014

    Enforcement

    Recall Number
    Z-0030-2015
    Event ID
    69085
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Navilyst Medical, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 15, 2014
    Initiation Date
    August 25, 2014
    Classification Date
    October 6, 2014
    Termination Date
    March 10, 2017
    Address
    10 Glens Falls Technical Park, Glens Falls, NY, 12801, United States

    Description

    PICC Convenience Kit with Accessories, BioFlo PICC with ENDEXO and PASV Valve Technology, 4F-55 cm SINGLE LUMEN, UPN Product No. H96560M1841541, REF/Catalog No. 60M184154, STERILE --- Navilyst Medical, Inc. 10 Glens Falls Technical Park Glens Falls, NY 12801

    Reason

    NMI was notified by the manufacturer of the 10 ml BD PosiFlush SF Saline Flush Syringes, that it had initiated a recall on specific lots of the syringes as some syringe unit packages exhibited open seals which may impact package integrity and potentially affect product sterility. Based on the notification, NMI is recalling specific PICC Kits that contain the affected 10 ml BD PosiFlush SF Saline Flush Syringes.

    Code Info

    Batch/Lot No. 4763165 (exp. 31-May-15)

    Distribution

    Nationwide Distribution

    Quantity

    3 units/pouches