BEUDAMED
    FDA Enforcement Class II Terminated

    Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax: +49 7222 932-1888 [email protected] www.maquet.com Used to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures

    Recall: Z-2210-2012 · Reported August 22, 2012

    Enforcement

    Recall Number
    Z-2210-2012
    Event ID
    62471
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Maquet Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 22, 2012
    Initiation Date
    May 29, 2012
    Classification Date
    August 15, 2012
    Termination Date
    April 3, 2014
    Address
    45 Barbour Pond Drive, Wayne, NJ, 07470, United States

    Description

    Maquet Getinge Group Pediatric Arterial Cannula Maquet Cardiopulmonary AG Kehler Strabe 31 76437 Rastatt Germany Phone +49 7222 932-0 Fax: +49 7222 932-1888 [email protected] www.maquet.com Used to introduce blood and sterile solution to the circulation system during extracorporeal circulation procedures

    Reason

    Certain pediatric arterial cannulas may have limited flexibility due to an increased length of the "hardened" cannula tip.

    Code Info

    510k023251 US Catalog Number 161412 Batch Number 92048923 Foreign Catalog number 161412 Batch number 92048923 Catalog number 161412 Batch number 92051578

    Distribution

    Worldwide Distribution - USA including MI, MN and Internationally

    Quantity

    20 devices US; 122 devices foreign