{
  "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": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "193222",
      "product_res_number": "Z-1108-2022",
      "event_date_initiated": "2022-04-01",
      "event_date_created": "2022-05-17",
      "recall_status": "Open, Classified",
      "res_event_number": "90042",
      "product_code": "MQK",
      "k_numbers": [
        "K162833"
      ],
      "product_description": "VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001\n\nThe VitriGuard device is a cryopreservation storage device composed of a stick and cap.",
      "code_info": "GTIN for UDI on Pouch: 00888937014792 GTIN for UDI on Box: 20888937014796  Lot 264453",
      "firm_fei_number": "1216677",
      "recalling_firm": "CooperSurgical, Inc.",
      "address_1": "95 Corporate Dr",
      "city": "Trumbull",
      "state": "CT",
      "postal_code": "06611-1350",
      "additional_info_contact": "Customer Service\n203-601-9818",
      "reason_for_recall": "Products in this lot may have compromised barrier seals, introducing a risk to sterility.",
      "root_cause_description": "Process control",
      "action": "On April 1, 2022, the firm distributed URGENT Medical Device Safety Notices to affected customers. Customers were informed of the potential breach to the sterile barrier of the affected lot. Customers should discontinue use of the affected lot and quarantine the product for return to CooperSurgical.\n\nIf you have additional questions, please contact a CooperSurgical Product Surveillance representative at 203.601.5200 Ext. 3300 or email the firm at recall@coopersurgical.com.",
      "product_quantity": "2,340 (US only)",
      "distribution_pattern": "Domestic distribution to AZ, CA, FL, IL, MI, MO, NY, OR, TX, and WV. No foreign distribution.",
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        "device_name": "Labware, Assisted Reproduction",
        "medical_specialty_description": "Obstetrics/Gynecology",
        "regulation_number": "884.6160",
        "device_class": "2"
      }
    }
  ]
}