{
  "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",
    "results": {
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      "cfres_id": "198019",
      "product_res_number": "Z-1199-2023",
      "event_date_initiated": "2022-12-20",
      "event_date_posted": "2023-03-01",
      "recall_status": "Open, Classified",
      "res_event_number": "91488",
      "product_code": "HOZ",
      "k_numbers": [
        "K920354"
      ],
      "product_description": "Ultracell Wick with 80cc Collection Bag, 20/box",
      "code_info": "Catalog #40430, Lot Numbers 21M3820 and 21L3403\n\nUDI/DI: 30886158012123",
      "firm_fei_number": "1211998",
      "recalling_firm": "Beaver Visitec International, Inc.",
      "address_1": "500 Totten Pond Rd 10 City Point",
      "city": "Waltham",
      "state": "MA",
      "postal_code": "02451-1916",
      "additional_info_contact": "Ms. Aminah Crawford\n781-906-7950",
      "reason_for_recall": "Device packaging may contain open seals, compromising product sterility.",
      "root_cause_description": "Process control",
      "action": "A consignee letter was issued to impacted customers on January 18, 2023. The communication advises consignees to immediately examine inventory and quarantine product from impacted lots. If further distribution has occurred, a sub-recall should be initiated. A completed copy of the Business Response Form shall be completed and returned to beavervisitec8978@sedgwick.com.",
      "product_quantity": "4640 units in total",
      "distribution_pattern": "US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI\n\nOUS distribution to Canada, Japan, and South Africa",
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        "device_name": "Sponge, Ophthalmic",
        "medical_specialty_description": "Ophthalmic",
        "regulation_number": "886.4790",
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}