Events

Device Recall MATResponder Tourniquet 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Pyng Medical Corporation 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
    72096
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0228-2016
  • 사례 시작날짜
    2015-08-31
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-07-05
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=139859
  • 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
    Tourniquet, nonpneumatic - Product Code GAX
  • 원인
    Once tested, it is required that the tourniquet be returned to its ready position then placed in its packaging. each tourniquet was tested for functionality, but in some cases, the tourniquet was not returned to its ready position prior to packaging.
  • 조치
    PYNG Medical sent Recall Notification letters dated August 28, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed: Please immediately cease use of the MATResponder and MATCombat tourniquet lots specified above. Inform all of your teams to cease use of or distribution of these lots. Please immediately place all MATResponder Tourniquets and MATCombat Tourniquets that you have in inventory into a quarantined location. For further questions please call (604) 303-7964. .

Device

Device Recall MATResponder Tourniquet
  • 모델명 / 제조번호(시리얼번호)
    MATR: lot numbers; SL115802 (Exp 07/2024), SL12136 (Exp 08/2024), SL121360 (Exp 12/2024), SL114711 (Exp 01/2024) MATC - lot numbers : SL12131 (Exp 07/2024), SL121312 (Exp 08/2024), SL113171 (Exp 10/2023).
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Distribution and to the countries of : Colombia, France, Canada, Italy, Germany, Finland, United Kingdom, Australia, The Netherlands, Japan, Hungary, Indonesia, Israel, Mexico, Poland and Spain.
  • 제품 설명
    MATResponder Tourniquet; Catalog number MATR: UPC 78353 00008; || MATCombat Tourniquet, Catalog number MATC; UPC 78353 00010; || MATResponder Tourniquet and MATCombat Tourniquet are essentially the same product with different color schemes || manual nonpneumatic tourniquet devices. The device provides for emergency blood flow occlusion to the limbs
  • Manufacturer
    Pyng Medical Corporation

Manufacturer

Pyng Medical Corporation
  • 제조사 주소
    Pyng Medical Corporation, 210-13480 Crestwood Pl, Richmond Canada
  • 제조사 모회사 (2017)
    Teleflex Incorporated
  • Source
    USFDA