BEUDAMED
    FDA Enforcement Class II Terminated

    Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, part number: 380-0916-01.

    Recall: Z-2093-2017 · Reported May 24, 2017

    Enforcement

    Recall Number
    Z-2093-2017
    Event ID
    77019
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Del Mar Reynolds Medical, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 24, 2017
    Initiation Date
    April 14, 2017
    Classification Date
    May 16, 2017
    Termination Date
    October 16, 2017
    Address
    1 2 Harforde Court John Tate Road, Business Park, Hertford, N/A, United Kingdom

    Description

    Spacelabs Healthcare Arkon Anesthesia Delivery System is intended for use in the hospital environment and operating room. Absorber Adapter Assembly Service Kit, part number: 050-9045-00. Absorber Adapter Assembly, part number: 650-1648-01. Arkon Absorber Canister Carrier, part number: 380-0916-01.

    Reason

    Reports of the Canister Carrier breaking during absorbent exchange or during anesthesia machine transit, causing a leak in the breathing circuit, which could cause hypoventilation in the patient.

    Code Info

    *********the serial numbers and part numbers of units distributed in the US ********* Absorber Adapter Assembly Service Kit part number: 050-9045-00. Devices serial numbers: ARKN-000395, ARKN-000396, ARKN-000397, ARKN-000398, ARKN-000399, ARKN-000400, ARKN-000401, ARKN-000402, ARKN-000403, ARKN-000404, ARKN-000405, ARKN-000406, ARKN-000407, ARKN-000408, ARKN-000409, ARKN-000410, ARKN-000411, ARKN-000412, and ARKN-000413. *********the serial numbers of units distributed international ************************** ARKN-000375, ARKN-000414, ARKN-000415, ARKN-000416, ARKN-000417, ARKN-000418, ARKN-000419, ARKN-000420, ARKN-000421, ARKN-000422, and ARKN-000423.

    Distribution

    US distribution in FL, LA, MS, NC, NC, SC and WY and Internationally to Panama and United Kingdom.

    Quantity

    62 total (US= 19 devices and 32 kits; International = 11 devices)