Device Recall Teleflex MEDICAL LMA(TM) MADgic(TM) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Teleflex Medical Europe Ltd 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
    79643
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1628-2018
  • 사례 시작날짜
    2018-03-19
  • 사례 상황
    Open, Classified
  • 사례 국가
  • 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
    Applicator (laryngo-tracheal), topical anesthesia - Product Code CCT
  • 원인
    Teleflex medical is recalling the affected product because there may be missing or incomplete information on the package label.
  • 조치
    The recall notice was disseminated by letter on 03/19/2018. The letter stated the following: "1. If you have affected stock, immediately discontinue use and quarantine any products with the product code and lot number listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter."

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot Number 161212
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    TX
  • 제품 설명
    Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region
  • Manufacturer

Manufacturer

  • 제조사 주소
    Teleflex Medical Europe Ltd, Ida Business Park, Athlone Ireland
  • 제조사 모회사 (2017)
  • Source
    USFDA