BEUDAMED
    FDA Enforcement Class II Terminated

    Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.

    Recall: Z-0272-2016 · Reported November 25, 2015

    Enforcement

    Recall Number
    Z-0272-2016
    Event ID
    72449
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Precision Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 25, 2015
    Initiation Date
    October 8, 2015
    Classification Date
    November 13, 2015
    Termination Date
    October 27, 2016
    Address
    300 Held Dr, N/A, Northampton, PA, 18067-1150, United States

    Description

    Easy Dial Oxygen Regulator, 168708D and 168715D. Eight liter from .0.25 to 8 liters, 15 liter from 0.5 liter to 15 liters of oxygen per minute.

    Reason

    These lots of Oxygen Dial Regulators could have the settings label off by one position. When the indicator arrow points to OFF position, the regulator is actually on the half liter setting (0.50), for the 15 liter. For the 8 liter, instead of being in the OFF position, the regulator will be in the quarter liter setting (0.25).

    Code Info

    Lot numbers 072215 and 072315.

    Distribution

    Distributed in the US to the states of PA, MA, MO, MT, ID, MI, MN, ND, KY, NY, NC, CA, AL, AZ, LA, OH, TX, GA, IN, and OK.

    Quantity

    315