Events

Device Recall Hotline Administration Sets 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smiths Medical ASD, Inc. 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
    60516
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0422-2012
  • 사례 시작날짜
    2011-11-21
  • 사례 출판 날짜
    2012-01-11
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-08-07
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=105681
  • 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
    Warmer, thermal, infusion fluid - Product Code LGZ
  • 원인
    Disconnected/ loose luer connectors at the patient end of the triple lumen tubing of the hotllne disposable administration sets and level 1 d/di-60hl normothermic iv administration sets.
  • 조치
    Smiths Medical notified consignees by letter dated November 28, 2011 titled: Urgent Field Safety Notice. The letter identified the affected product, the problem, and the actions to be taken. Customers were instructed to inspect inventory and segregate unused affected product. Distributors were instructed to immediately stop distributing and quarantine all inventory. The letters included a Confirmation Form to be complete and return, by fax to 781-610-9859 or by email to hotlineconnectorrecall@smiths-medical.com. For questions consignees were instructed to contact Smiths Medical at 1781-763-9330.

Device

Device Recall Hotline Administration Sets
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 1961565 1967233 1967234 1967235 1967236 1967237 1967238 1967239 1967240 1973118 1973119 1982938 1982939 1983243 1983244 1983246 1989241 1989242 1989243 1989244 1989245 1995431 1995554 1995555 1995556 1995698 1995699 1995700 1995701 1995702 2007275 2007276 2007277 2007278 2019640 2019641 2019642 2019643 2019644 2025123 2025125 2025126 2025127 2025128 2025129 2025130 2025131 2025133 2025134 2025135 2033081 2033082 2033083 2033084 2033085 2033086 2042613 2042614 2042615 2042617 2042618 2049316 2049317 2049318 2049437 2049438 2055173 2055174 2055175 2055176 2059473 2059474 2059475 2064014 2064015 2064017 2064018 2068138 2068139 2068140 2068141 2068142 2077203 2077204 2077205 2077206 2077207 2083507 2083508 2084305 2090782 2090783 2093663 2093664 2095298 2095300 2101204 2101205 2101206 2101207 2101208
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution  (USA) (nationwide) - Argentina, Austria, Australia, Belgium, Bahrain, Bermuda, Canada, Chile, China, Columbia, Czech Republic, Germany, Denmark, Estonia, Egypt, Finland, France, Great Britain, Guernsey, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel India, Iceland, Italy, Japan, South Korea, Kazakhstan, Lebanon, Luxembourg, Mexico, Malaysia, New Caledonia, Netherlands, Norway, New Zealand, Panama, Poland, Portugal, Qatar, Singapore, Sweden, Slovak Republic, South Africa, Spain, Sri Lanka, Switzerland, Taiwan, and Vatican City State.
  • 제품 설명
    HOTLlNE¿ Disposable Administration Sets, Product Codes L-70 || Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE¿ Routine Flow Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of blood and I.V. solutions, at normothermic flow rates of 50 - 5,000 ml/hr.
  • Manufacturer
    Smiths Medical ASD, Inc.

Manufacturer

Smiths Medical ASD, Inc.
  • 제조사 주소
    Smiths Medical ASD, Inc., 160 Weymouth St, Rockland MA 02370-1136
  • Source
    USFDA