Events

Device Recall HUDSON RCI 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Teleflex Medical 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    71360
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-2367-2015
  • 사례 시작날짜
    2015-06-01
  • 사례 출판 날짜
    2015-08-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-04-16
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=137446
  • 비고 / 경고
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • 데이터 추가 비고
    Tube, tracheal/bronchial, differential ventilation (w/wo connector) - Product Code CBI
  • 원인
    The double swivel connector may crack or separate on the endobronchial tube.
  • 조치
    Teleflex Medical sent an Urgent Medical Device Recall Notification letter dated June 1, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were directed to contact any customers who had received the product included within the scope of this recall. Customers were directed to immediately discontinue use and quarantine any products with the referenced catalog numbers and lot numbers listed in the notification. Additionally, customers were asked to return any affected product together with a completed Recall Acknowledgement Form, for consolidation and return to Teleflex Medical. For questions contact your local sales representative or Customer Service at 1-866-246-6990.

Device

Device Recall HUDSON RCI
  • 모델명 / 제조번호(시리얼번호)
    Product Code: 5-16028, Lot numbers: 01L1300279, 01A1400574, 73D1400255, 73F1400448, 73J1400537, 73A1500341 and 73C1500431; Product Code: 5-16035, Lot numbers: 01J1300471, 01J1300472, 01K1300050, 01K1300073, 01K1300578, 01L1300382, 01L1300383, 01L1300557, 01M1300073, 01M1300312, 01A1400226, 01A1400432, 01B1400083, 01B1400356, 01B1400357, 01C1400260, 73D1400097, 73E1400504, 73F1400449, 73G1400387, 73G1400597, 73H1400033, 73H1400332, 73J1400259, 73J1400260, 73J1400261, 73K1400130, 73K1400131, 73K1400132, 73K1400225, 73K1400226, 73K1400227, 73L1400236, 73L1400382, 73L1400383, 73L1400384, 73L1400489, 73L1400583, 73L1400608, 73A1500481, 73A1500482, 73B1500077, 73B1500078, 73B1500353, 73B1500529, 73B1500530, 73B1500531, 73C1500256, 73C1500257, 73C1500581 and 73D1500099; Product Code: 5-16037, Lot numbers: 01K1300143, 01K1300144, 01K1300346, 01K1300347, 01K1300579, 01L1300081, 01L1300280, 01L1300281, 01L1300384, 01L1300558, 01M1300074, 01M1300117, 01M1300213, 01M1300313, 01A1400121, 01A1400194, 01A1400433, 01A1400575, 01B1400084, 01B1400115, 01B1400242, 01C1400087, 01C1400088, 01C1400285, 73D1400256, 73D1400627, 73E1400270, 73E1400366, 73F1400189, 73G1400053, 73G1400176, 73H1400034, 73H1400161, 73H140033, 73H1400442, 73J1400538, 73J1400547, 73K1400341, 73K1400342, 73K1400343, 73K1400462, 73L1400098, 73L1400234, 73L1400235, 73L1400584, 73L1400609, 73M1400071, 73M1400072, 73M1400073, 73M1400192, 73M1400193, 73A1500342, 73A1500343, 73A1500344, 73A1500590, 73A1500589, 73B1500076, 73B1500532, 73C1500110, 73C1500111, 73C1500531, 73C1500532, 73C1500582, 73D1500096, 73D1500097 and 73D1500098; Product Code: 5-16039, Lot numbers: 01K1300469, 01L1300082, 01L1300083, 01L1300559, 01M1300214, 01A1400227, 01A1400576, 01B1400243, 01B1400478, 73C1400067, 73D1400340, 73E1400114, 73F1400353, 73G1400256, 73G1400377, 73J1400398, 73J1400408, 73K1400463, 73L1400196, 73L1400097, 73M1400194, 73A1500483, 73A1500484, 73A1500591, 73A1500592, 73C1500112, 73C1500113, 73C1500258, 73C1500259, 01L1300385, 01A1400122, 01C1400261, 73E1400115, 73G1400388, 73J1400399, 73A1500204, 73B1500533, 73C1500583, 01L1300155 and 01A1400453; Product Code: 5-16041, Lot numbers: 73B1500256, 01C1400406, 73D1400497, 73F1400095, 73J1400116, 73J1400133, 73K1400464 and 73K1400465.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US (nationwide) and the countries of: The Bahamas, Belgium, Argentina, Canada, China, India, Japan, South Korea, Mexico, New Zealand and Vietnam.
  • 제품 설명
    HUDSON RCI, Sheridan Sher-I-BRONCH, Endobronchial Tube (Left sided), Sizes: 28 Fr., 35 Fr., 37 Fr., 39 Fr. and 41 Fr., Rx Only, Sterile. || Intended for use in thoracic surgery, bronchospirometry, for the administration of bronchial anesthesia and other uses commonly requiring bronchial intubation.
  • Manufacturer
    Teleflex Medical

Manufacturer

Teleflex Medical
  • 제조사 주소
    Teleflex Medical, 2917 Weck Dr, Research Triangle Park NC 27709-0186
  • 제조사 모회사 (2017)
    Teleflex Incorporated
  • Source
    USFDA