BEUDAMED
    FDA Enforcement Class II Terminated

    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-14. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    Recall: Z-0098-2013 · Reported October 31, 2012

    Enforcement

    Recall Number
    Z-0098-2013
    Event ID
    63276
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Westmed Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 31, 2012
    Initiation Date
    January 18, 2011
    Classification Date
    October 20, 2012
    Termination Date
    October 22, 2012
    Address
    5580 S Nogales Hwy Ste 170, N/A, Tucson, AZ, 85706-3333, United States

    Description

    Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 1 cc, 25 g x 5/8" A Needle, 25U Balanced Heparin, part number: 3173-14. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations.

    Reason

    Westmed is recalling Westmed ABG convenience kits containing TRIAD brand alcohol pads because TRIAD is recalling TRIAD brand alcohol pads due to potential contaminants.

    Code Info

    Lot Numbers: 38638, 38940, 39139, 39318, 39418, 39480, 39744, 39947, 43620, 43893, 45730, 46483, 46658, 46799, 47927, 48073,

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada, El Salvador, United Arab Emirates, Holland, Costa Rica and Lebanon.

    Quantity

    1,259,200 units total