Events

Device Recall LMA Esophageal Intubation Detector (EID), Catalog Number EID100 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 LMA North America 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
    62337
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2022-2012
  • 사례 시작날짜
    2012-05-23
  • 사례 출판 날짜
    2012-07-17
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-12-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110279
  • 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 (w/wo connector) - Product Code BTR
  • 원인
    The recall was initiated because lmana has received a complaint that the esophageal intubation detector (eid100) has a potential to create a false positive if used on a patient during confirmation of intubation.
  • 조치
    LMA North America Inc. sent a recall letter dated May 23, 2012, for US customers, and May 24, 2012, for International customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to fill out the bottom portion of the recall letter and promptly fax it back to LMA North America at (858) 622-4130. If customers have units of EID100 from the affected lots remaining in stock, customers were instructed to arrange for immediate return by contacting LMANA's customer service department at (800) 788-7999, menu selection #2. For further questions please contact Customer Service Representative at (800) 788-7999.

Device

Device Recall LMA Esophageal Intubation Detector (EID), Catalog Number EID100
  • 모델명 / 제조번호(시리얼번호)
    2009 Lot # 90923A, 91222A. 2010 Lot# 00327A, 00518A, 00623A, 00831B, 01013A, 01103A, 01214A.  2011 Lot# 10110A, 10301B, 10423A, 10530A, 10602A, 10703A, 10804A, 11004A. 2012 Lot# 120104, 120414.
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) and the countries of Canada, United Kingdom, ZA, and Australia.
  • 제품 설명
    LMA Esophageal Intubation Detector (EID), Catalog Number EID100 || The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment
  • Manufacturer
    LMA North America Inc

Manufacturer

LMA North America Inc
  • 제조사 주소
    LMA North America Inc, 4660 La Jolla Village Dr Ste 900, San Diego CA 92122-4608
  • 제조사 모회사 (2017)
    Lma North America, Incorporated
  • Source
    USFDA