Device Recall CaviWipes1 Extra Large 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Metrex Research, LLC. 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
    76318
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1402-2017
  • 사례 시작날짜
    2017-01-20
  • 사례 출판 날짜
    2017-03-03
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2017-09-01
  • 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
    Disinfectant, medical devices - Product Code LRJ
  • 원인
    Metrex is recalling the caviwipes extra large because they may have been contaminated during the packaging process.
  • 조치
    Metrex sent an Urgent Medical Device Recall letter dated January 20, 2017, to all affected customers to inform them that Metrex is recalling one lot of CaviWipes Extra Large because they may have been contaminated during the packaging process. Customers were informed that while handling sealed containers, a production worker sustained a minor finger cut which may have come in contact with the exterior surface of the container. Customers were instructed to contact Metrex Customer care at (800) 537-7123 to receive a RMA number. The RMA will allow for a quick return and replacement or credit. Customers were instructed to identify any customers that may have been shipped the affected product and contact their customers using the customer notification letter that Metrex issued. Metrex requests that those customers contact Metrex Customer Care at (800) 537-7123 and complete the attached acknowledgement form. For questions regarding this recall call 734-947-6700.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot No. 16-2340PA
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution to PA, FL, IL, MN, TX, AL, NY
  • 제품 설명
    CaviWipes1 Extra Large, Part No. 13-5150 || The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigned the product code LRJ (General Purpose Disinfectant) by the FDA and is classified as a Class I Medical Device. CaviWipes1 Extra Large is intended to be used to disinfect surfaces.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Metrex Research, LLC., 28210 Wick Rd, Romulus MI 48174-2639
  • 제조사 모회사 (2017)
  • Source
    USFDA