FluroEthyl. 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Gebauer Company 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
    49463
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0218-2009
  • 사례 시작날짜
    2008-09-03
  • 사례 출판 날짜
    2008-11-12
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2010-10-13
  • 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
    Topical (vapocoolant) refrigerant. - Product Code MLY
  • 원인
    Some units of fluro-ethyl containing the defective valve which could malfunction and spray refrigerant out from the side of the valve in addition to or instead of spraying in the normal inverted position from the product's actuator. the product can also leak coolant from the side of the valve onto the fingers of the user.
  • 조치
    A recall notification letter (Recall Notice) (dated 9/3/2008) was issued on 9/16/2008 to customers. The notice instructs customers to check their inventory for any remaining recall product and if found, return the product to the Gebauer Company. The letter also advises distributors to notify their customers and follow instructions as noted above, i.e. customers inventory their stock for recalled product and if found, return to the Gauber Company. For questions or additional information, contact Gebauer Company at 216-581-3030 (ext. 120) or 800-321-9348.

Device

  • 모델명 / 제조번호(시리얼번호)
    Model Number: P/N 0386-0002-20. Lot Numbers: 7010, 7011, and 7012.
  • 의료기기 분류등급
  • 의료기기 등급
    Unclassified
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Gebauer's Fluro-Ethyl¿ Nonflammable Topical Anesthetic Skin Refrigerant (Aerosol Can) P/N 0386-0020-20. The product consists of a can, a valve and an actuator. || Gebauer's Fluro-Ethyl¿ is a vapocoolant (skin refrigerant), topical anesthetic intended to control the pain associated with minor surgical procedures, dermabrasion and injection. It is also effective in providing temporary relief from the pain associated with minor sports injuries.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Gebauer Company, 4444 E 153rd St, Cleveland OH 44128
  • Source
    USFDA