Events

SteriVac 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 3M Company - Health Care Business 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
    63214
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0022-2013
  • 사례 시작날짜
    2012-09-13
  • 사례 출판 날짜
    2012-10-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-01-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=113036
  • 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
    Sterilizer ethylene-oxide gas - Product Code FLF
  • 원인
    3m determined that the electrical grounding mechanism for the steri-vac 5xl and 8xl gas sterilizer/aerator did not meet all of the requirements of the standard in that the electrical wiring, which is insulated and contained within the sealed door should have a stronger connection to the protective electrical grounding mechansim.
  • 조치
    3m Healthcare Service Center sent a Urgent Medical Device Field Correction letter dated September 19. 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 3M will contact you to schedule an appointment for a field correction on any unit in the range of serial numbers provided in the table. 3Ms goal is to service the affected units with minimal disruption to your facility. We apologize for any inconvenience this field correction may cause. Please be assured that 3M is committed to the highest level of safety and customer service and we are proud of our longstanding safety record for 3M" Steri-Vac" Gas Sterilizers. For Further Information If you have any questions, please contact the 3M Health Care Service Line at 1-800-688-5888 or your local 3M representative. .

Device

SteriVac
  • 모델명 / 제조번호(시리얼번호)
    Model 5XL 1-door, serial numbers from 721799 - 722166.  Model 5XL 2-door, serial numbers from 820248 - 820285.  Model 8XL 1-door, serial numbers from 350608 - 350887. Model 8XL 2-door, serial numbers from 450073 - 450105
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) including the states of AL, CO, CT, GA, IN, KY, MA, MI, MN, MO, MS, NJ, OH, PA, SC, TN, VA, WA and WI., and the countries of Argentina, Barbados, Chile, China, Colombia, Costa Rica, Ecuador, Germany, India, Indonesia, Japan, Korea, Kuwait, Lebanon, Malaysia, Mexico, Morocco, Pakistan, Paraguay, Peru, Philippines, Poland, Republic of Guinea, Russia, South Africa, Taiwan, Thailand, Trinidad, UAE, Venezuela, Vietnam and Zimbabwe.
  • 제품 설명
    3M Steri-Vac Gas Sterilizer/Aerator models 5XL and 8XL. || 3M Steri-Vac Gas Sterilizer/Aerator is a compact unit designed to sterilize heat- and/or moisture-sensitive devices. This gas sterilizer/aerator is intended for indoor use only.
  • Manufacturer
    3M Company - Health Care Business

Manufacturer

3M Company - Health Care Business
  • 제조사 주소
    3M Company - Health Care Business, 3M Center 2510 Conway Ave , B# 275-5-W-6, Saint Paul MN 55144
  • 제조사 모회사 (2017)
    3m Company
  • Source
    USFDA