{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
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    }
  },
  "results": [
    {
      "cfres_id": "114384",
      "product_res_number": "Z-0411-2013",
      "event_date_initiated": "2012-10-17",
      "event_date_posted": "2012-11-20",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-04-09",
      "res_event_number": "63629",
      "product_code": "ETD",
      "product_description": "PARPARELLA-TYPE VENT TUBE, 1.02 MM,  SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC.,\n\nTympanostomy tube",
      "code_info": "JC470075",
      "firm_fei_number": "3003790304",
      "recalling_firm": "Gyrus Acmi, Incorporated",
      "address_1": "136 Turnpike Road",
      "city": "Southborough",
      "state": "MA",
      "postal_code": "01772-2118",
      "additional_info_contact": "Terrence E. Sullivan\n508-804-2739",
      "reason_for_recall": "One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.",
      "root_cause_description": "Material/Component Contamination",
      "action": "The firm, Olympus, sent an \"URGENT: Medical Device Recall\" letter dated October 15, 2012 to their consignees/customers. The letter describes the product, problem and actions to be taken.  The customers were instructed to inspect their stock to confirm if any of the affected lot of product remains in their possession; immediately cease any further use of any affected product; remove it from their stockroom and quarantine it until it is shipped back to Gyrus ACMI, Inc.; call their Gyrus ACMI customer service representative (800-773-4301) to obtain a Returned Goods Authorization and promptly return any affected product to Gyrus ACMI, Inc., 2925 Appling Rd, Bartlett, TN 38133., and complete and return the RECALL REPLY FORM to Attn: Regulatory Affairs via fax to: (508) 804-2624, even if there is no affected stock left at your facility.\n\nIf you have any questions, contact  the customer service at 800-773-4301.",
      "product_quantity": "10 boxes/60 units",
      "distribution_pattern": "Worldwide distribution: USA state of Kansas and country of Korea.",
      "openfda": {
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          "K830228",
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          "K781259",
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        ],
        "device_name": "Tube, Tympanostomy",
        "medical_specialty_description": "Ear, Nose, Throat",
        "regulation_number": "874.3880",
        "device_class": "2",
        "registration_number": [
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