Events

Advanced Sterilization Products 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Advanced Sterilization Products 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
    33513
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0197-06
  • 사례 시작날짜
    2005-09-16
  • 사례 출판 날짜
    2005-11-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-11-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41983
  • 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
    The sterrad 100 and the sterrad 100s vaporizer plates are prone to displacement allowing micro-droplets of h2o2 to contact the load. if the vaporizer plate is dislodged, there is an increased chance for operators to have contact with h2o2 resulting in transient burns during the removal of the load.
  • 조치
    The recall strategy consists of supplying each customer of the STERRAD 100 and the STERRAD 1OOS with: a notification letter of the field action (mailed 09/22/05 ), a pack containing two vaporizer plates of the newly released design, and a set of instructions for self-installation.

Device

Advanced Sterilization Products
  • 모델명 / 제조번호(시리얼번호)
    20220 STERRAO 100 Accessory Kit 1.8 20221 STERRAO 100 Accessory Kit 2.0 20222 STERRAO 100 Accessory Kit 2.0  Same as 20221 except single ply  paper 20223 STERRAO 1 DOS Accessory Kit A  (For use with Block 1.8  STERRAO 100S) 20224 STERRAO 1 DOS Accessory Kit B  (For use with Block 2.0  STERRAO 1 DOS) 20225 STERRAO 100S Accessory Kit C  (For use with Block 2.0  STERRAO System  & Block 1.8 STERRAO with  Printer UpQrade kit install 03-53045- 1- 001 Vaporizer Plate, Shelf Pac 03-05660- 0- 001
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide and Canada, Germany, & Japan. Note: A more detail list of international consignees pending.
  • 제품 설명
    Vaporizer Plate Vaporizer Plate Consumable accessory used with the STERRAD 100 and the STERRAD 100S
  • Manufacturer
    Advanced Sterilization Products

Manufacturer

Advanced Sterilization Products
  • 제조사 주소
    Advanced Sterilization Products, 33 Technology Dr, Irvine CA 92618-2346
  • 제조사 모회사 (2017)
    Johnson & Johnson
  • Source
    USFDA