Events

Device Recall Fisherbrand Sterile Swabs 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Fisher Scientific Co 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
    65822
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1955-2013
  • 사례 시작날짜
    2013-06-05
  • 사례 출판 날짜
    2013-08-12
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-10-20
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120307
  • 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, absorbent tipped, sterile - Product Code KXG
  • 원인
    The firm is recalling fisherbrand sterile swabs due to 4 customer complaints reporting the presence of non-pathogenic organisms in two lots. the finding was confirmed in lot 61513 and lot 8710 is also being recalled as a precautionary measure.
  • 조치
    Customers were notified by letter on June 18, 2013 and requested to discontinue use and return all affected product. The firm also asked that any additional affected customer base be contacted and notified of the recall if the lots had been further distributed. If you have any questions, contact Stericycle (reference "Event 4070") at 1-877-410-5558.

Device

Device Recall Fisherbrand Sterile Swabs
  • 모델명 / 제조번호(시리얼번호)
    Product code # 14-959-81, lot #61513, expiration date: 2014-08, and lot 8710, expiration date 2014-08.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide and the country of Canada.
  • 제품 설명
    Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab 100 pouches/boxes, 10 boxes/case. || Used in applying medications to or take specimens from a patient.
  • Manufacturer
    Fisher Scientific Co

Manufacturer

Fisher Scientific Co
  • 제조사 주소
    Fisher Scientific Co, 300 Industry Dr, Pittsburgh PA 15275-1001
  • 제조사 모회사 (2017)
    Thermo Fisher Scientific Inc
  • Source
    USFDA