{
  "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,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "141788",
      "product_res_number": "Z-0390-2016",
      "event_date_initiated": "2015-10-21",
      "event_date_posted": "2015-12-04",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-07-12",
      "res_event_number": "72534",
      "product_code": "DXE",
      "k_numbers": [
        "K992368"
      ],
      "product_description": "LeMaitre NovaSil Silicone Single Lumen Embolectomy Catheter 2F, 60 cm, Model e1801-26.  Indicated for the removal of arterial emboli and thrombi.",
      "code_info": "Lot Number: NSE1658¿",
      "firm_fei_number": "1220948",
      "recalling_firm": "LeMaitre Vascular, Inc.",
      "address_1": "63 2nd Ave",
      "city": "Burlington",
      "state": "MA",
      "postal_code": "01803-4413",
      "additional_info_contact": "Salva Kozin\n781-221-2266 Ext. 108",
      "reason_for_recall": "Manufacturing issue that could cause a pinhole in the formed end of the packaging, which may lead to compromised sterility.",
      "root_cause_description": "Packaging process control",
      "action": "Consignees were notified of the recall on October 21, 2015 via letter. Consignees were asked to do the following: Identify all catheters with the affected LOT and model numbers in inventory; quarantine all unused catheters from the affected LOTs and record this action in the attached form; send the form via mail, email or fax to Customer Service who will then issue an RMA-number (Return Merchandise Authorization number) for the return shipment and replacement of the products;   pass this notice on to all those who need to be aware within your organization and to any organization to which the potentially affected devices have been transferred. For questions concerning this safety notice, please contact Salva Kozin, Quality Assurance Engineer, at 781-221-2266 ext. 183.",
      "product_quantity": "4315 total",
      "distribution_pattern": "Worldwide Distribution.  US nationwide including PUERTO RICO, and Australia, AUSTRIA, BELGIUM, COLOMBIA, COSTA RICA, Czech Republic, DENMARK, EGYPT, FRANCE, GERMANY, ICELAND, Italy, JAPAN, JORDAN, Latvia, LUXEMBOURG, MOROCCO, NETHERLANDS, Norway, Oman, PERU, PORTUGAL, Poland, Slovenia, Spain,  Switzerland,  Sweden, THAILAND,  United Kingdom, United Arab Emirates, and VIETNAM.",
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          "1000138054",
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        ],
        "device_name": "Catheter, Embolectomy",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5150",
        "device_class": "2"
      }
    }
  ]
}