{
  "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": "219985",
      "product_res_number": "Z-2262-2026",
      "event_date_initiated": "2026-04-22",
      "event_date_posted": "2026-05-29",
      "recall_status": "Open, Classified",
      "res_event_number": "98852",
      "product_code": "NEP",
      "k_numbers": [
        "K002705"
      ],
      "product_description": "Brand Name: Exacta Mix\nProduct Name: Vented Micro-Volume Inlet\nModel/Catalog Number: H938175\n \nProduct Description: Tubing sets with push-on connector on one end (to attach to the Fluid Selector Valve) and a spike or other appropriate connector on the opposite end to attach the source container.",
      "code_info": "Lot Code: Lot numbers: 804084, 804088, and 804089\nUDI Number: 00085412475806",
      "firm_fei_number": "1417572",
      "recalling_firm": "Baxter Healthcare Corporation",
      "address_1": "1 Baxter Pkwy",
      "city": "Deerfield",
      "state": "IL",
      "postal_code": "60015-4625",
      "additional_info_contact": "Center for One Baxter\n1-847-9484770",
      "reason_for_recall": "Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow efficiency, incomplete or slower transfers of ingredients, or system alarms. This issue may lead to clinical effects such as\nelectrolyte imbalance, metabolic instability, delayed recovery, etc.",
      "root_cause_description": "Under Investigation by firm",
      "action": "On April 22, 2026, the firm began notifying consignees via letters titled URGENT PRODUCT RECALL. Customers were instructed to locate impacted product. Customers may choose to inspect impacted inlets and continue to use those with the correct 3-micron filter, or they may choose to discard impacted inlet lots without inspection and product will be replaced.",
      "product_quantity": "105675",
      "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maine, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia. The countries of Taiwan and Uruguay.",
      "openfda": {
        "registration_number": [
          "3012205369",
          "3003704957",
          "3010291427",
          "3033536319",
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        ],
        "fei_number": [
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          "3003704957",
          "3010291427",
          "1000306431",
          "3033536319",
          "3013557562",
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          "3010659131",
          "3002710954",
          "1526863",
          "3003094851",
          "3002669612",
          "3008514120",
          "3013561817",
          "3044994889",
          "3011292417",
          "3014579161",
          "3002807257",
          "2521402",
          "1416980",
          "3008808123",
          "3002807111",
          "3002806588",
          "1000632857",
          "3007880912",
          "3013764800",
          "3010421104",
          "3006571738",
          "3000215205"
        ],
        "device_name": "System/Device, Pharmacy Compounding",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5440",
        "device_class": "2"
      }
    }
  ]
}