Events

Device Recall 3M" SteriVac" Gas Sterilizer/Aerators 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
    67716
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1318-2014
  • 사례 시작날짜
    2014-03-17
  • 사례 출판 날짜
    2014-04-02
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-01-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126136
  • 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
    Recently, 3m received a single report of a potential exposure to ethylene oxide (eo) at a hospital installation involving 3m" steri-vac" gas sterilizers. the cause was traced to a rare situation involving a failure of the eo cartridge puncture assembly. this assembly was only in production during the period november 10, 2006 through december 14, 2007 and in service during the period february 7, 20.
  • 조치
    3M sent an "Urgent Medical Device Field Correction" letter dated March 6, 2014. The letter was sent to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. You are being notified because our records indicate you received a unit that contains the cartridge puncture assembly that is the subject of this field correction. 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. 3M's goal is to service the affected units with minimal disruption to your facility. Units manufactured outside of the dates November 10, 2006 to December 14, 2007 are not affected. .For Further Information contact 3M Health Care Service Line at 1-800-228-3957 or your local 3M representative.

Device

Device Recall 3M" SteriVac" Gas Sterilizer/Aerators
  • 모델명 / 제조번호(시리얼번호)
    Model SKU Starting S/N Ending S/N 5XL 70-2007-2303-2 721115 721309 5XL 70-2007-2304-0 820174 820201 5XL 70-2007-2575-5 780066 780102 8XL 70-2006-8493-7 350136 350268 8XL 70-2006-8498-5 450016 450027  4XL 523122, 522205, 522502, 522287, 522655.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA (nationwide) Distribution including the states of AL, AZ, CA,CO, FL, GA, HI, IL, IN, IA, KS, KY, MD, MA, MI, MN, MS, NE, NJ, NY, NC, ND, OH, OK,OA, SC, TX, WA, WV and WI. and the countries of COLOMBIA, VENEZUELA, UAE, THAILAND, GERMANY, CHINA, KOREA, CANADA, JAPAN, RUSSIA, INDIA, POLAND, PERU, AUSTRIA, ISRAEL, INDONESIA, SPAIN, CHILE, MALAYSIA, SWITZERLAND, EL SALVADOR, ECUADOR, LEBANON, MEXICO, ARGENTINA, BULGARIA, TAIWAN, TURKEY,ROMANIA, GUATEMALA and NEW ZEALAND.
  • 제품 설명
    3M" Steri-Vac" Gas Sterilizer/Aerators, Model #'s 4XL,5XL, 8XL || The 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