BEUDAMED
    FDA Enforcement Class II Terminated

    ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with Anspach Systems

    Recall: Z-1897-2014 · Reported July 2, 2014

    Enforcement

    Recall Number
    Z-1897-2014
    Event ID
    64247
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    The Anspach Effort, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 2, 2014
    Initiation Date
    November 28, 2012
    Classification Date
    June 25, 2014
    Termination Date
    August 7, 2014
    Address
    4500 Riverside Drive, N/A, Palm Beach Gardens, FL, 33410-4235, United States

    Description

    ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with Anspach Systems

    Reason

    The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

    Code Info

    Part Number: 98-0039, 98-0040, 98-0050, 98-0057; Serial Numbers: C06301529106, 200058302, 200058301, 200057701, 200057702, 200058402, 200058401, 200057802, 200057801, C05301514406, C06301529102, C8301529004, C08301529002, C06301529102, C08301529007, C08301529006, C08301529002, 200058301. 200069302, 200069301, D31200076202, D31200076203, D31200076204, D31200076201, D31200079014, D31200079007, D31200079015, D31200079012, D31200079010, D31200079016, D31200079001, D31200079004, D31200079008, D31200079003, D31200079009, D31200079002, D31200079006, D31200079011, D31200079017, D31200079013.

    Distribution

    Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

    Quantity

    45