{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Hertford",
      "state": "N/A",
      "country": "United Kingdom",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "64535",
      "recalling_firm": "Del Mar Reynolds Medical, Ltd.",
      "address_1": "1-2 Harforde Ct., Foxholes",
      "address_2": "Business Park",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide Distribution - USA Nationwide including the states of New Mexico, North Carolina and the countries of Argentina, China, Mexico, and Taiwan.",
      "recall_number": "Z-0968-2013",
      "product_description": "Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber.        Anesthesia workstation for use in the hospital environment and locations not requiring portability.",
      "product_quantity": "108 total (17 units in the US and 91 units outside the US)",
      "reason_for_recall": "A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient.",
      "recall_initiation_date": "20130115",
      "center_classification_date": "20130320",
      "termination_date": "20130514",
      "report_date": "20130327",
      "code_info": "serial numbers:    ABSO-004448, ABSO-004458, ABSO-004459, ABSO-004460, ABSO-004461, ABSO-004462, ABSO-004463, ABSO-004465, ABSO-004466, ABSO-004467, ABSO-004468, ABSO-004469, ABSO-004470, ABSO-004471, ABSO-004472, ABSO-004473, ABSO-004474, ABSO-004475, ABSO-004476, ABSO-004477, ABSO-004478, ABSO-004479, ABSO-004480, ABSO-004481, ABSO-004482, ABSO-004483, ABSO-004487, ABSO-004488, ABSO-004489, ABSO-004490, ABSO-004491, ABSO-004492, ABSO-004493, ABSO-004494, ABSO-004495, ABSO-004497, ABSO-004499, ABSO-004500, ABSO-004503, ABSO-004504, ABSO-004505, ABSO-004506, ABSO-004507, ABSO-004508, ABSO-004510, ABSO-004511, ABSO-004512, ABSO-004513, ABSO-004526, ABSO-004528, ABSO-004529, ABSO-004530, ABSO-004531, ABSO-004532, ABSO-004533, ABSO-004534, ABSO-004535, ABSO-004536, ABSO-004537, ABSO-004538, ABSO-004539, ABSO-004540, ABSO-004541, ABSO-004542, ABSO-004543, ABSO-004544, ABSO-004545, ABSO-004564, ABSO-004566, ABSO-004567, ABSO-004568, ABSO-004569, ABSO-005883, ABSO-005884, ABSO-005885, ABSO-005886, ABSO-005887, ABSO-005945, ABSO-005947, ABSO-005948, ABSO-005949, ABSO-005950, ABSO-100023, ABSO-100024, ABSO-100038, ABSO-100039, ABSO-100040, ABSO-100041, ABSO-100042, ABSO-100043, ABSO-100070, ABSO-100071, ABSO-100072, ABSO-100073, ABSO-100074, ABSO-100075, ABSO-100076, ABSO-100077, ABSO-100078, ABSO-100079, ABSO-100080, ABSO-100081, ABSO-100082, ABSO-100083, ABSO-100084, ABSO-100085, ABSO-100086, and ABSO-100087.     Firm added ABSO 004581 - which was inSpacelaabs inventory, in transit to a Field Service Engineer, at the time the recall was initiated.  the nonconforming absorber has been replaced with a conforming part and this absober serial number was added to the US Spacelabs Recall tracking.    Five incorrect serialnumbers were included in the original serial numbers provided to FDA.  This was a result of a data entry error.  An updated US and Rest of the World customer/Serial number was provided to FDA 3/25/2013.  The correction to the Rest of the World report is as follows:  Incorrect SN Reported to FDA Correct, Nonconforming SN  ABSO 005883                         ABSO-004514  ABSO 005884                         ABSO-004515  ABSO 005885                         ABSO-004516  ABSO 005886                         ABSO-004517  ABSO 005887                         ABSO-004518"
    }
  ]
}