Events

ProSpore 4 mL 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Mesa Laboratories Inc 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
    76101
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1104-2017
  • 사례 시작날짜
    2016-04-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-01-26
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=152157
  • 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
    Indicator, biological sterilization process - Product Code FRC
  • 원인
    Product resistance has fallen outside of label claim within expiry.
  • 조치
    MesaLabs sent an Urgent Notification letter dated April 4. 2016 to customers. Follow-up emails were sent to verify receipt. The letter identified the affected product, problem and actions to be taken. For questions contact MesaLabs technical support team via email at bi-support@mesalabs.com or call at 303-987-8000 ext. 10042.

Device

ProSpore 4 mL
  • 모델명 / 제조번호(시리얼번호)
    Lot # 637, exp. date 12/2016
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Product was distributed to: AL, AR, CA, FL, IA, MO, NE, NC, NY, OH, and WA. The product was also distributed internationally, including Mexico and Canada. There was no goverment or military distribution.
  • 제품 설명
    ProSpore 4 mL Ampoule Biological indicator for steam sterilization, contains Geobacillus stearothermophilus, Catalog Number: PS-6-50, contains 50 Ampoules/Box. || Product Usage: || Biological indicator for steam sterilization at 121 deg C intended for use by a health care provider to accompany products being sterilized through steam sterilization procedure and to monitor adequacy of sterilization.
  • Manufacturer
    Mesa Laboratories Inc

Manufacturer

Mesa Laboratories Inc
  • 제조사 주소
    Mesa Laboratories Inc, PO Box 27261, 8607 Park Dr, Omaha NE 68127-3623
  • 제조사 모회사 (2017)
    Mesa Laboratories Inc
  • Source
    USFDA