Events

Amsco VPRO 1 and Amsco VPRO 1 Plus Low Temperature Sterilization Systems 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Steris Corporation 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
    59520
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-3041-2011
  • 사례 시작날짜
    2011-08-01
  • 사례 출판 날짜
    2011-08-19
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-03-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=102995
  • 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, chemical - Product Code MLR
  • 원인
    Steris learned that amsco¿ v-pro 1 and v-pro 1 plus low temperature sterilization systems users may experience premature wear of the vacuum pump and filtering assembly components. users may also experience incomplete aeration of the device's chamber following a failed leak test.
  • 조치
    Steris Corporation sent an URGENT VOLUNTARY FIELD CORRECTION NOTICE dated August 5, 2011, to all affected customers.The letter identified the product the problem and the action needed to be taken by the customer. A STERIS Service Representative will contact your facility to arrange for STERIS to upgrade your V-PRO System(s). You can continue to use your system prior to the installation of the system upgrades. In the interim period should you experience any alarms or aborted cycles, the load must be handled in accordance with the Amsco¿ V-PROTM 1 and V-PROTM 1Plus Low Temperature Sterilization Systems Operators Manual and your internal hospital procedures. For further information or if you have questions regarding this matter, please contact Field Service Dispatch at 1-800-333-8828.

Device

Amsco VPRO 1 and Amsco VPRO 1 Plus Low Temperature Sterilization Systems
  • 모델명 / 제조번호(시리얼번호)
    Model #MLR, V-PRO 1: S/N 033250701 through S/N 031571106; V-PRO 1 Plus: S/N 031800801 through S/N 031581115
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA (nationwide) including the states of: AK, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV & WY, and countries of: Australia, Bangladesh, Belgium, Belarus, Brazil, Canada, Chile, China, Colombia, Costa Rica, Denmark, Ecuador, Egypt, Finland, France, Germany, Hungary, India, Iraq, Ireland, Italy, Japan, Kuwait, Lebanon, Mexico, New Zealand, Oman, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, South Korea, Spain, Switzerland, Turkey, Vietnam, United Arab Emirates, and United Kingdom.
  • 제품 설명
    Amsco¿ V-PRO 1 and Amsco¿ V-PRO 1 Plus Low Temperature Sterilization Systems Model #MLR, Serial # 033250701 - 031581115. || The STERIS Amsco¿ V-PRO and V-PRO 1 Plus Low Temperature Sterilizer are self-contained stand alone devices, using vaporized hydrogen peroxide as the sterilant. The sterilizer is intended for use in the terminal sterilization of cleaned, rinsed, and dried, reusable metal and nonmetal medical devices used in healthcare facilities. The sterilization cycle operates at low pressure and temperatures, and is therefore suitable for processing medical devices sensitive to heat and moisture.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • 제조사 주소
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060
  • 제조사 모회사 (2017)
    Steris Plc
  • Source
    USFDA