{
  "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": "2026-09-05",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "219763",
      "product_res_number": "Z-2873-2026",
      "event_date_initiated": "2026-07-06",
      "event_date_posted": "2026-08-11",
      "recall_status": "Open, Classified",
      "res_event_number": "98777",
      "product_code": "NGT",
      "k_numbers": [
        "K082689",
        "K103740"
      ],
      "product_description": "Brand Name: Elevaris/Spectra Medical Devices\nProduct Name: Sodium Chloride Injection, 0.9%, USP 10mL  Ampule\nModel/Catalog Number: AMPUL10MLK.  \n Sodium Chloride Flush for IV tubing systems and indwelling intravascular access devices.",
      "code_info": "Lot Code: Product codes: 1510-1 (individual ampule) / 1510-2 (carton)  \n\nLots:  AB3005, AB3006, AB3007, AB3008, AB3009, AB3010, AB4001, AB4002, AB4003, AB4004, AB4005\nAB4006, AB5001, AB5002, AB5003, AB5004, AB5005,AB5006, AB5007, AB5008\n\nNo individual UDI, as this product is used only within convenience kits.",
      "firm_fei_number": "3000204727",
      "recalling_firm": "Spectra Medical Devices, Llc",
      "address_1": "299 Ballardvale St",
      "address_2": "Ste 1",
      "city": "Wilmington",
      "state": "MA",
      "postal_code": "01887-1066",
      "additional_info_contact": "Kathy Dassler\nUS-978-6570889",
      "reason_for_recall": "Manufacturing firm, Huons, was cited for issues regarding product quality and sterility assurance. If the product sterility is compromised, patients may be exposed to microorganisms, endotoxins, or foreign matter. This may trigger inflammatory responses, infections, micro-clots, and organ failure.",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "On July 6, 2026, firm sent letters titled, \"Urgent: Medical Device Recall\" to customers.\n\nCustomers were instructed to examine their stock for affected product and discard or return any unused Sodium Chloride Flush ampules from the identified lot numbers.\n\nFor affected products already in distribution, customers should instruct downstream customers to discard or return unused product.\n\nCustomers were also instructed to use extra vigilance in detecting and reporting potential patient health concerns that may be related to this product.",
      "product_quantity": "TBD",
      "distribution_pattern": "Distributed in the United States to medical device kit packers in six (6) states - CA, FL, NC, OK, TX, VA.",
      "openfda": {
        "k_number": [
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          "K213522",
          "K250884",
          "K020999",
          "K230756",
          "K231754",
          "K032438",
          "K192414",
          "K231363",
          "K171109",
          "K042061",
          "K153481",
          "K091583",
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          "K223584",
          "K101270",
          "K150143",
          "K082837",
          "K113555",
          "K121050",
          "K173348",
          "K214080",
          "K111034",
          "K191378",
          "K142620",
          "K011283",
          "K231724",
          "K090882",
          "K231161",
          "K103740",
          "K133685",
          "K161552",
          "K082689",
          "K233623",
          "K183473",
          "K141311",
          "K201286",
          "K121262",
          "K120836",
          "K020996"
        ],
        "registration_number": [
          "1423982",
          "1054241",
          "3007163376",
          "1047843",
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          "3005806438",
          "9616657",
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        ],
        "fei_number": [
          "3005698992",
          "3003040625",
          "1047843",
          "3004080548",
          "3007163376",
          "1043214",
          "1000151124",
          "1000112968",
          "3008002452",
          "3005669815",
          "3005934752",
          "3009848807",
          "3036113190",
          "2518902",
          "3043709866",
          "3025432964",
          "1000112877",
          "3012494290",
          "3001677091",
          "3010882708",
          "3020460367",
          "2243072",
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          "3002682307",
          "3036706541",
          "3000215273",
          "1000122362",
          "3002907620",
          "3017509841",
          "3016413378",
          "3016972038",
          "1526711",
          "3002695476",
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          "3010405396",
          "3015060216",
          "3034669683",
          "3010407203",
          "3003737899",
          "3011508621",
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          "3004756837",
          "3038181770",
          "3001236277",
          "3014421917",
          "3000204727",
          "3008518459",
          "3016707060",
          "3036757319",
          "1911916",
          "3005806438",
          "3007590959"
        ],
        "device_name": "Saline, Vascular Access Flush",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5200",
        "device_class": "2"
      }
    }
  ]
}