{
  "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": "2026-09-17",
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      "cfres_id": "193260",
      "product_res_number": "Z-1132-2022",
      "event_date_initiated": "2022-04-22",
      "event_date_created": "2022-05-25",
      "recall_status": "Open, Classified",
      "res_event_number": "90059",
      "product_code": "MCZ",
      "product_description": "Surgical Suture Kit",
      "code_info": "Part Number: ZZ-0958; Primary DI Number: M752ZZ09580; Lot Numbers: 213639474, 212957814, 212675717",
      "firm_fei_number": "1450943",
      "recalling_firm": "Stradis Healthcare",
      "address_1": "3600 Burwood Dr",
      "city": "Waukegan",
      "state": "IL",
      "postal_code": "60085-8399",
      "additional_info_contact": "Phil Toblin\n847-596-7740",
      "reason_for_recall": "There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.",
      "root_cause_description": "Under Investigation by firm",
      "action": "The firm, Stradis Health, initiated an \"URGENT: MEDICAL DEVICE RECALL\" on 04/22/2022 via email. The letter instructs the consignee to examine your inventory and immediately quarantine any affected product; contact Stradis Customer Service to arrange or return, shipment of the recalled product along with a full refund, credit or product substitute. Stradis Customer Service can be reached at 1-800-886-7257 or by email at cs@stradishealthcare.com. Notify their customer within 48 hours and the customers should contact the firm to arrange for a return. The firm is also requesting that the consignees return an acknowledgement form. \n\nIf you have any questions regarding this notification, please do not hesitate to contact us at 1-800-886-7257.",
      "product_quantity": "7340 units",
      "distribution_pattern": "US Distribution to NC.",
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        "device_name": "Suture Removal Kit",
        "medical_specialty_description": "General, Plastic Surgery",
        "regulation_number": "878.4800",
        "device_class": "1"
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