{
  "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,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "184568",
      "product_res_number": "Z-0753-2021",
      "event_date_initiated": "2020-11-11",
      "event_date_created": "2020-12-30",
      "recall_status": "Terminated",
      "event_date_terminated": "2022-08-09",
      "res_event_number": "86800",
      "product_code": "OFP",
      "product_description": "Smoothbore breathing system with exhalation port 22 mm Device REF #: B0062001 Custom Anasthesia Breathing Systems; Multipac Anasthesia Breathing Systems - Product Usage: intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and   Y-piece.",
      "code_info": "Model Number: B0062001 Lot Numbers: 4200283 and 4200286 UDI Codes: (01)00081647202239(10)4200286 (01)00081647202239(10)4200283",
      "firm_fei_number": "1000120301",
      "recalling_firm": "Intersurgical Inc",
      "address_1": "6757 Kinne St",
      "city": "East Syracuse",
      "state": "NY",
      "postal_code": "13057-1215",
      "additional_info_contact": "Marissa Hovey\n800-828-9633",
      "reason_for_recall": "The device was assembled with the incorrect exhalation port which can cause gas leakage.",
      "root_cause_description": "Process control",
      "action": "Recall Strategy and Instruction:\n1.  Immediately discontinue use and quarantine any stock with the product/lot number described  above in this recall notification.\n2.  If you have distributed any of these products, please immediately contact your customers, advise them of the recall situation and have them return their outstanding recalled stock to you.\n3.  Complete the Customer Product Recall Acknowledgement Form\n   a.  Return the completed form via email to Intersurgical Inc. at \n        mhovey@intersurgicalinc.com.\n   b.  The subject line should contain Intersurgical Recall: Company name\n   c.   Please note: If you do not have the recalled product in stock, please check \n         the appropriate box on the Customer Product Recall Acknowledgement \n         Form.\n4.  Once we receive your Customer Product Recall Acknowledgement Form, \n     Intersurgical Customer Support will issue a Return Goods Authorization \n     (RGA) Number for the amount of product you have  on-hand to return.\n   a.  Intersurgical will credit your account when the product is received.\n\nIntersurgical is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact Customer Support at 800-828-9633 or email at support@intersurgicalinc.com.\n\nDistribution:\nDistribution began 09/02/2020\nDistributed: 200 pieces",
      "product_quantity": "200 devices",
      "distribution_pattern": "All of the devices were shipped to the same distributor (McKesson).",
      "openfda": {
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          "3004122598",
          "3034669683",
          "3045816902",
          "3013510193",
          "3006534321",
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        ],
        "device_name": "Anesthesia Breathing Circuit Kit (Adult & Pediatric)",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5240",
        "device_class": "1"
      }
    }
  ]
}