{
  "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": "2026-08-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "48256",
      "product_res_number": "Z-0158-2007",
      "event_date_initiated": "2006-09-01",
      "event_date_posted": "2006-11-07",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-12-19",
      "res_event_number": "36252",
      "product_code": "DTQ",
      "k_numbers": [
        "K943803"
      ],
      "product_description": "Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank",
      "code_info": "Article # 923391 The affected HL-20 base units include S/Ns 100001 through 100240.  Hand cranks shipped between the dates of 8/15/05 to 8/14/06 have the potential to be defective.  Serial #s100155, 1025, 1026, 1032, 1331, 1332, 100011, 100015, 100016, 100017, 1272, 1417, 1480, 1500, 1653, 14031054, 14031055, 14031059, 14041074, 14041874, 100012, 100013, J14041874, 1584, 100108, 100109, 14041074, JOSTRA, 100009, 100010, 100130, 100131, 1625, 1626, 1627, 1628, 1629, 100135, 100136, 100137, 14031040, 14031068, 100188, 1019, 1020, 1021, 1295, 100021, 100022, 100116, 14031051, 14031052, 1507, 1508, 1509, 100017, 100219, 100220, 100221, 100222,  100223, 100224, 100225, 100226, 100227, 100228.",
      "firm_fei_number": "3008355164",
      "recalling_firm": "MAQUET Inc.",
      "address_1": "1140 US Highway 22",
      "city": "Bridgewater",
      "state": "NJ",
      "postal_code": "08807-2958",
      "additional_info_contact": "Jamie Yieh\n908-947-2311",
      "reason_for_recall": "The hand crank necessary for the emergency manual operation of the pump is too wide diametrically to fit into the holes which they were designed to fill.",
      "root_cause_description": "Other",
      "action": "The firm sent a safety alert letter on 9/13/06 to all US customers by Federal Express Return Receipt.",
      "product_quantity": "132 or less in US. Firm officials stated that 66 base units in US 8/1/05 to 8/14/06 - each units comes with 2 hand cranks.",
      "distribution_pattern": "worldwide",
      "openfda": {
        "k_number": [
          "K090006",
          "K173834",
          "K813034",
          "K770002",
          "K822068",
          "K080832",
          "K102726",
          "K842138",
          "K915183",
          "K052555",
          "K002118",
          "K221895",
          "K093882",
          "K092463",
          "K091007",
          "K060053",
          "K190282",
          "K851614",
          "K202125",
          "K030141",
          "K070213",
          "K163531",
          "K172220",
          "K942582",
          "K062396",
          "K022947",
          "K002116",
          "K153376",
          "K801097",
          "K943803",
          "K870976",
          "K851615",
          "K863541",
          "K871131",
          "K950990",
          "K071318",
          "K232291",
          "K982014",
          "K103762",
          "K863960",
          "K772001",
          "K131041",
          "K964017",
          "K861388",
          "K011088",
          "K133598",
          "K210130",
          "K020571",
          "K021694",
          "K151349",
          "K221373",
          "K862973"
        ],
        "registration_number": [
          "3011554160",
          "3005941719",
          "8010762",
          "1828100",
          "3019807891",
          "2184009",
          "9680841",
          "1218444",
          "3002807090",
          "2916596",
          "3001589655",
          "3010703925",
          "3009507273",
          "3007427881",
          "3006073153",
          "9611109",
          "3010163695",
          "3042990265"
        ],
        "fei_number": [
          "3006003617",
          "3011554160",
          "3005426550",
          "3009649876",
          "1828100",
          "3019807891",
          "3002808267",
          "1218444",
          "3002807111",
          "1000116158",
          "2916596",
          "3001589655",
          "3010703925",
          "3006073153",
          "3009507273",
          "3007427881",
          "3010163695",
          "3042990265"
        ],
        "device_name": "Console, Heart-Lung Machine, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4220",
        "device_class": "2"
      }
    }
  ]
}