BEUDAMED
    FDA Recall 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 · Initiated June 21, 2016

    Recall

    Recall Number
    Z-2365-2016
    Event Number
    74581
    Firm
    Invacare Corporation
    FEI Number
    3002889431
    Product Code
    NFB
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 21, 2016
    Posted
    August 8, 2016
    Terminated
    February 7, 2017
    Address
    1 Invacare Way, Elyria, OH, 44035-4190

    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.

    Action

    lnvacare Corporation sent an Urgent Medical Device Recall letter dated June 27, 2016, to all affected consignees with return receipt to notify them of the recall. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees with questions were instructed to call 877-413-6008.

    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