Device Recall Jet Ventilation Catheter (transtracheal) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 VBM 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
    58807
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2676-2011
  • 사례 시작날짜
    2011-05-09
  • 사례 출판 날짜
    2011-06-28
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2012-03-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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, tracheostomy (w/wo connector) - Product Code BTO
  • 원인
    Product labeled with incorrectly as being appropriate for use in adults when the intended population for use of the product is children and infants.
  • 조치
    VBM Medical Inc sent an "URGENT FIELD SAFETY NOTICE" dated May 9, 2011, to all affected customers. The letter identified the product, the problem, and the action needed to be taken by the customer. The reference and lot numbers, details of the error, along with the incorrect and correct box label, and instructions to the customers to discard the box with the incorrect label or send the complete product back to VBM Medical Inc. for re-packaging. For any further or detailed questions, please contact VBM Medical Inc. at (317) 776-1800. On 7/12/11 upon receiving the recall classification letter, the firm sent out an additional letter to its direct accounts informing them of the recall's classification and reiterating the instructions listed above.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot number 28326
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA ( nationwide ) including the country Montreal QC
  • 제품 설명
    Jet-Ventilator Catheter for Adults, 14G, STERILE, NO LATEX, REF 30-02-918-1, VBM Medizintechnik GmbH, Einsteinstrasse 1 7212 Sul z a.N. Germany || Allows a safe and atraumatic transtracheal access for oxygenation/ventilation with a manual jet ventilator or an automatic high frequency jet ventilator.
  • Manufacturer

Manufacturer

  • 제조사 주소
    VBM Medical Inc., 524 Herriman Ct, Noblesville IN 46060-4363
  • 제조사 모회사 (2017)
  • Source
    USFDA