Events

Device Recall Introes Pocket Bougie 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Brathwaites Oliver 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
    75148
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0067-2017
  • 사례 시작날짜
    2016-08-19
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149464
  • 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
    Stylet, tracheal tube - Product Code BSR
  • 원인
    The introes pocket bougie an endotracheal tube introducer size 14 fr (4.7mm) x 60 cm may break during intubation.
  • 조치
    On August 19, 2016 the firm sent a MEDICAL DEVICE RECALL NOTICE & CORRECTIVE ACTION letter to affected customers. The letter described the reason for the recall and necessary actions to be taken by the consignees. These included: BOMImed is requesting bougies with lot# 101615 to be returned for evaluation due a potential manufacturing concern. Complete the included Medical Device Recall Customer Letter and follow the instructions to obtain a Return Material Authorization number and applicable shipping instructions to return the affected products. BOMImed Regulatory department also requires the below Customer Confirmation section to be completed and return to regulatory@bomimed.com to confirm this notification was received.

Device

Device Recall Introes Pocket Bougie
  • 모델명 / 제조번호(시리얼번호)
    Model OL-E12102, lot# 101615.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    U.S. Consignee located in the following states: IL, WI, WE, OR, NY, UT, IN, NE, PA, MO, OH, AZ, MA, CT and NC.*** Foreign Consignee: Canada.
  • 제품 설명
    The Introes Pocket Bougie is an endotracheal tube introducer. The device is an endotracheal tube introducer and it is used as a guide during intubation. Anesthesiology.
  • Manufacturer
    Brathwaites Oliver Medical

Manufacturer

Brathwaites Oliver Medical
  • 제조사 주소
    Brathwaites Oliver Medical, 96 Terracon Place, Winnipeg Canada Manitoba
  • Source
    USFDA