BEUDAMED
    FDA Recall 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 · Initiated October 8, 2015

    Recall

    Recall Number
    Z-0272-2016
    Event Number
    72449
    Firm
    Precision Medical, Inc.
    FEI Number
    2523148
    Product Code
    CAN
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    October 8, 2015
    Posted
    November 13, 2015
    Terminated
    October 27, 2016
    Address
    300 Held Dr, Northampton, PA, 18067-1150

    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).

    Action

    The firm sent "Attention Field Corrective Action" letters, dated Oct 8, 2015, to customers. The letter identified the affected device and explained the reason for the recall. The letter provided instructions on how to check the regulator; and asked customers to call the number provided for a replacement if a regulator is labeled incorrectly.

    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