Events

Device Recall Drger Breathing Bag 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Draeger Medical, 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
    67808
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1452-2014
  • 사례 시작날짜
    2014-03-25
  • 사례 출판 날짜
    2014-04-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-10-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126375
  • 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
    Set, tubing and support, ventilator (w harness) - Product Code BZO
  • 원인
    Reusable latex breathing bags with various part numbers and sold as part of test lung and reusable anaesthesia sets were recalled when draeger became aware of an incident where a user suffered an acute allergic reaction after using a dr¿ger latex test lung. the user did not suffer permanent injury. the breathing bag that belongs to the test lung and other latex breathing bags are labelled nr. a.
  • 조치
    A recall notification letter, dated March 2014, was sent to wholesale distributors and end users.

Device

Device Recall Drger Breathing Bag
  • 모델명 / 제조번호(시리얼번호)
    Reusable latex breathing bags with part numbers 2165686, 2165953, 2165694, as part of test lung part number 8403201, and reusable anaesthesia sets part numbers M33681 and M27542.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    USA Nationwide Distribution in the states of: MI, SC, CO, OH, NE, WI, NC, SD, AZ, TX, MA, WA, PA, KY, MN, GA, OK, NY, IN, VA, UT, MT, ME,FL, CA, MD, MO, IA, TN, MD, WV, IL,NJ, CT, and AR.
  • 제품 설명
    Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthesia sets. || Product Usage: The breathing bag is a component of the anesthesia set (breathing circuit) that is intended to is the conduit for administering medical gases to a patient during ventilation. It provides both an inspiratory and expiratory route. 2. The test lung is an apparatus that contains a breathing bag and and connector. It is connected to the output of a ventilator and is used as part of the device/system check out.
  • Manufacturer
    Draeger Medical, Inc.

Manufacturer

Draeger Medical, Inc.
  • 제조사 주소
    Draeger Medical, Inc., 3135 Quarry Rd, Telford PA 18969-1042
  • 제조사 모회사 (2017)
    Stefan Dräger GmbH
  • Source
    USFDA