BEUDAMED
    FDA Enforcement Class II Terminated

    Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton. The lnvacare Precise Rx" Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow.

    Recall: Z-2365-2016 · Reported August 17, 2016

    Enforcement

    Recall Number
    Z-2365-2016
    Event ID
    74581
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Invacare Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 17, 2016
    Initiation Date
    June 21, 2016
    Classification Date
    August 8, 2016
    Termination Date
    February 7, 2017
    Address
    1 Invacare Way, Elyria, OH, 44035-4190, United States

    Description

    Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton. The lnvacare Precise Rx" Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow.

    Reason

    The rear gradation scale was screen printed upside down on the flowmeter gauge.

    Code Info

    Serial numbers for Model IRCPF16AW: 16CF024370, 16CF024373, 16CF024376, 16CF024379, 16CF024382,16CF024368,16CF024369, 16CF024371,16CF024372, 16CF024374,16CF024375, 16CF024377,16CF024378, 16CF024380,16CF024381, 16CF037743.

    Distribution

    Worldwide Distribution - US to CA, CO, CT, FL, GA, IA, ID, IL,IN,KS,KY,LA,MA,MD,MI,MS,MT,NC,NE,NJ,NM,NY,OH,PA,SC, TN,TX,UT,VA,WA and Internationally to Canada, Germany and New Zealand.

    Quantity

    395 units