{
  "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,
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  "results": [
    {
      "cfres_id": "95830",
      "product_res_number": "Z-0569-2011",
      "event_date_initiated": "2010-11-15",
      "event_date_posted": "2010-12-09",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-12-04",
      "res_event_number": "57315",
      "product_code": "NGT",
      "k_numbers": [
        "K032438"
      ],
      "product_description": "MONOJECT Prefill Heparin Lock Flush Syringe\n100 Unit Heparin, 5 ml in 12 ml syringe\nItem code 8881590125",
      "code_info": "Lot # 9082104, 9082114, 9082154, 9092164",
      "firm_fei_number": "1282497",
      "recalling_firm": "Covidien LP",
      "address_1": "15 Hampshire St",
      "city": "Mansfield",
      "state": "MA",
      "postal_code": "02048-1113",
      "additional_info_contact": "508-261-8000",
      "reason_for_recall": "The heparin sodium USP used to manufacture was produced with crude heparin containing Over-Sulfated Chondroitin Sulfate.",
      "root_cause_description": "Material/Component Contamination",
      "action": "COVIDEN sent an URGENT PRODUCT RECALL letter dated November 12, 2010, to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.  Customers were instructed to examine their inventory and in-use stock to determine if they had any units of the affected product and quarantine the product immediately.   Distributors were instructed to notify their customers immediately of the URGENT PRODUCT RECALL letter.  Customers were to fill out the enclosed response form and return it by fax  to (203) 822-6009 or email to adfeedback@coviden.com following the instructions on the form. \nFor questions customers were to contact Customer Service at 1-800-962-9888",
      "product_quantity": "1,539,540",
      "distribution_pattern": "Nationwide Distribution including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, LA, KS, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, WV and Bermuda",
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        "device_name": "Saline, Vascular Access Flush",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5200",
        "device_class": "2"
      }
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}