BEUDAMED
    FDA Enforcement Class II Terminated

    ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.

    Recall: Z-0561-2015 · Reported December 17, 2014

    Enforcement

    Recall Number
    Z-0561-2015
    Event ID
    69666
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Pfm Medical Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 17, 2014
    Initiation Date
    October 20, 2014
    Classification Date
    December 9, 2014
    Termination Date
    April 23, 2015
    Address
    1815 Aston Ave Ste 106, N/A, Carlsbad, CA, 92008-7340, United States

    Description

    ASEPT Pleural Drainage System, Pleural Drainage Catheter Kit, Ref No. P09080001, M7001 Product Usage: The pfm medical ASEPT Pleural Drainage System is a tunneled, long term catheter used to drain accumulated fluid from the pleural cavity in order to relieve symptoms associated with pleural effusions.

    Reason

    PFM Medical is recalling catheters and other medical devices because they may exceed USP limits for bacterial endotoxin.

    Code Info

    Lot No. 1307-024, 1302-031, 1210-015

    Distribution

    Worldwide Distribution - US Nationwide in the states of MA, NC, UT, PA, TX, OH, LA and worldwide to: Germany and Malaysia.

    Quantity

    120 units