Device Recall Tpiece Nebulizer with inline connectors 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Salter Labs 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
    73130
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0796-2016
  • 사례 시작날짜
    2016-01-05
  • 사례 출판 날짜
    2016-02-10
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2016-04-21
  • 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
    Nebulizer (direct patient interface) - Product Code CAF
  • 원인
    Reports that the t-piece does not fit on the nebulizer.
  • 조치
    A customer letter dated 1/13/16 was sent to all customers who purchased the T-piece Nebulizer with in-line connectors because of reports that the T-piece does not fit on the nebulizer. The letter informs the customers that there has been no reports of interruption or delay in therapy. Customers are instructed to contact Salter Labs Customer Service at 1-800-421-0024 to arrange for the return of the product and replacement inventory. Customers are instructed to acknowledge receipt of the communication by completing the attached reply form and faxing it to the number indicated on the attached form. Customers are instructed to contact Salter Labs Customer Support at 800-421-0024 or your local Salter Labs representative to document any issues that you have encountered or to request replacement inventory.

Device

  • 모델명 / 제조번호(시리얼번호)
    Lot No. 083115, 090715, and 122815
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed in the states of TX, NY, PA, TN, SC, and OH, and in China.
  • 제품 설명
    T-piece Nebulizer with in-line connectors, Part number 8915-7-50. Single patient use, non-sterile prescription device designed for use in a hospital or home care environment.
  • Manufacturer

Manufacturer