{
  "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,
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  "results": [
    {
      "cfres_id": "171120",
      "product_res_number": "Z-1027-2019",
      "event_date_initiated": "2019-02-04",
      "event_date_created": "2019-03-19",
      "recall_status": "Open, Classified",
      "res_event_number": "82197",
      "product_code": "GAL",
      "k_numbers": [
        "K001299"
      ],
      "product_description": "Plain and Chromic Gut Absorbable Surgical Sutures, sterile. 12 sutures per box.\n\nProduct Usage:\nPlain Gut Sutures are indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neural tissues.",
      "code_info": "Product Code (lot code): 822PG-HUF (170927-52, 180611-59); 822PG-DAR (171205-52); 810PG-1 (180924-51); 822PG-1 (180924-53)",
      "firm_fei_number": "3012164473",
      "recalling_firm": "CP Medical Inc",
      "address_1": "1775 Corporate Dr Ste 150 1775 Corporate Dr",
      "address_2": "Ste 150",
      "city": "Norcross",
      "state": "GA",
      "postal_code": "30093-2960",
      "reason_for_recall": "Potential compromise of product sterility after routine monitoring for Endotoxins showed an out of limit test result.",
      "root_cause_description": "Under Investigation by firm",
      "action": "CP Medical initially notified consignees via telephone call on about 02/01/2019.  Consignees were gain notified via \"URGENT: Recall Notice\" via email on about 02/04/2019 and followed up with the same letter sent via FedEx on about 02/20/2019.  \n\nInstructions included to immediately discontinue selling or using the affected product, return any affected product back to CP Medical, notify customers if the affected product was further distributed, and complete and return the \"Recall Checklist.\"  \n\nA request for a Returns Goods Authorization (RGA) and questions can be directed to Customer Service at 800-950-2763 and CP-CustomerService@cpmedical.com",
      "product_quantity": "1,905 boxes (22,860 sutures total)",
      "distribution_pattern": "Worldwide Distribution - US Nationwide to IA, IL, NY, SC.  \n\nDistributed internationally to Canada.",
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        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4830",
        "device_class": "2",
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