{
  "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,
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    }
  },
  "results": [
    {
      "cfres_id": "191272",
      "product_res_number": "Z-0570-2022",
      "event_date_initiated": "2022-01-07",
      "event_date_created": "2022-02-08",
      "recall_status": "Open, Classified",
      "res_event_number": "89327",
      "product_code": "KDJ",
      "k_numbers": [
        "K152675"
      ],
      "product_description": "Baxter MiniCap Extended Life PD Transfer Set (Easy-Lock), 5C4449",
      "code_info": "All lot numbers within expiry",
      "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\n800-422-9837",
      "reason_for_recall": "Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.",
      "root_cause_description": "Other",
      "action": "Baxter disseminated a Urgent Medical Device Correction letter on 7 January 2022 to peritoneal dialysis centers and will follow with notice to the patients on 12 January 2022.  The notices warned that the use of cleaning products and solvents may \ncause damage (for example, leaking or cracking), if they come into direct contact with the transfer set.  Baxter will be updating the Instructions for Use (IFU) to include a warning against the use of these cleaning products and solvents.  For general questions regarding this communication, contact Baxter Corporate Product Surveillance at 800-437-5176.",
      "product_quantity": "23,940 units",
      "distribution_pattern": "Worldwide",
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        "device_name": "Set, Administration, For Peritoneal Dialysis, Disposable",
        "medical_specialty_description": "Gastroenterology, Urology",
        "regulation_number": "876.5630",
        "device_class": "2"
      }
    }
  ]
}