{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 104
    }
  },
  "results": [
    {
      "cfres_id": "29332",
      "product_res_number": "Z-0027-04",
      "event_date_initiated": "2003-08-28",
      "event_date_posted": "2003-10-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-05-23",
      "res_event_number": "27163",
      "product_code": "LNW",
      "product_description": "Lactate Disposable Membrane Caps\nProduct Number: 0018108400",
      "code_info": "US Distribution Lot Numbers: N307, Exp. 1/30/04                       N30601,  Exp 12/30/03 International Distribution: N30301\tExp 9/30/03 N30501\tEXp 11/30/03 N306\tExp  12/30/03 N30604\tExp 12/30/03 N308\tExp  2/28/04",
      "firm_fei_number": "1217183",
      "recalling_firm": "Instrumentation Laboratory Co.",
      "address_1": "113 Hartwell Avenue",
      "city": "Lexington",
      "state": "MA",
      "postal_code": "02173",
      "additional_info_contact": "Carol Marble\n781-861-4467",
      "reason_for_recall": "Lactate Disposable Membrane Caps linearity was determined to be significantly biased and could potentially cause erroneous patient results above 6.0 mmol/L.",
      "root_cause_description": "Other",
      "action": "Instrumentation Laboratories notified  two (2) U.S. direct customers on August 28, 2003 by telephone, regarding Lot N30601. Follow-up phoning emphasizing significance of linearity problem (and additional involved lot  N307 - for 1 affected customer) performed on September 3, 2003. Phone call followed with faxback acknowledging notification and disposition of remaining product lot(s).  IL service also dispatched to customer sites on September 4, 2003.\nInternational Distributor Notices sent to IL Europe and IL Mexico on September 4, 2003. Product Information Bulletins circulated on September 3, 2003, to IL personnel worldwide.",
      "product_quantity": "287 boxes",
      "distribution_pattern": "IL, NY\nInternational: Italy, Mexico",
      "openfda": {
        "k_number": [
          "K960648",
          "K012230",
          "K032161",
          "K850858"
        ],
        "registration_number": [
          "",
          "3032109",
          "3008517993",
          "3043127647",
          "3013077867",
          "3005630901",
          "3018126397",
          "3009585529",
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          "3010852191",
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          "3038206980",
          "3020956494"
        ],
        "fei_number": [
          "",
          "3008517993",
          "3043127647",
          "3003333011",
          "3013077867",
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          "3012725363",
          "3025041446",
          "3010852191",
          "3008987086",
          "3038206980",
          "3020956494"
        ],
        "device_name": "Paper, Obstetric Ph",
        "medical_specialty_description": "Clinical Chemistry",
        "regulation_number": "862.1550",
        "device_class": "1"
      }
    }
  ]
}