{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "95387",
      "product_res_number": "Z-0600-2011",
      "event_date_initiated": "2010-11-01",
      "event_date_posted": "2010-12-10",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-02-13",
      "res_event_number": "57096",
      "product_code": "NZW",
      "k_numbers": [
        "K092491"
      ],
      "product_description": "Medefil Heparin I.V. Flush Syringe 10 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 10 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc. Glendale Heights, IL 60139.  The pre-filled syringes were packed as 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC# 64253-222-21, catalog # MIH-2221: 1 mL fill in 6 mL syringe; b) NDC# 64253-222-23, catalog # MIH-2223: 3 mL fill in 6 mL syringe; c) NDC# 64253-222-35, catalog # MIH-2235: 5 mL fill in 12 mL syringe",
      "code_info": "a) catalog # MIH-2221: Lot H10228, exp. date 04/12; b) catalog # MIH-2223: Lot H10262, exp. date 05/12; c) catalog # MIH-2235: Lot H10190, exp. date 03/12; Lot H10229, exp. date 04/12; Lot H10278, exp. date 06/12.",
      "firm_fei_number": "3001677091",
      "recalling_firm": "Medefil Incorporated",
      "address_1": "250 Windy Point Dr",
      "city": "Glendale Heights",
      "state": "IL",
      "postal_code": "60139-3805",
      "additional_info_contact": "Mr. Pradeep Aggarwal\n630-682-4600",
      "reason_for_recall": "The heparin lock flush solution was manufactured with contaminated Heparin Sodium USP Active Pharmaceutical Ingredient (API).",
      "root_cause_description": "Material/Component Contamination",
      "action": "Medefil faxed/emailed the direct accounts on 11/1/10, and sent the accounts a hard copy of the Urgent Product Recall letter, dated 11/1/2010, on 11/2/10.  The accounts were informed of Medefil's recall of 18 lots of Heparin I.V. Flush Syringes produced from the active pharmaceutical ingredient (API) Heparin Sodium, USP, lot 1035-0780, that has been recalled by the manufacturer, Scientific Protein Laboratories, due to the presence of a contaminant, Oversulfated Chondroitin Sulfate.  The accounts were instructed to stop use of the 18 lots of Heparin I.V. Flush Syringes immediately, place them under quarantine, and contact Medefil to arrange for the product to be returned. The accounts were requested to complete and return to Medefil the enclosed response form, indicating the quantity on hand of each recalled lot.  Any questions were directed to Pradeep Aggarwal, President at 630-682-4600.",
      "product_quantity": "583,500 syringes",
      "distribution_pattern": "Nationwide Distribution --- including states of Arizona, California, Florida, Illinois, Ohio, Louisiana, Massachusetts, Michigan, Minnesota, New York, Texas, and Virginia.",
      "openfda": {
        "k_number": [
          "K061497",
          "K092491",
          "K133446",
          "K090680",
          "K092938",
          "K163591",
          "K023740"
        ],
        "registration_number": [
          "1911916",
          "1423982",
          "3011689956",
          "3012421607",
          "1423507",
          "2027791",
          "3008518459",
          "2243072"
        ],
        "fei_number": [
          "1000122362",
          "3008002452",
          "1911916",
          "3011689956",
          "3012421607",
          "3001677091",
          "3008518459",
          "2243072"
        ],
        "device_name": "Heparin, Vascular Access Flush",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5200",
        "device_class": "2"
      }
    }
  ]
}