Events

Device Recall Quick Connect 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
    65138
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1596-2013
  • 사례 시작날짜
    2013-03-04
  • 사례 출판 날짜
    2013-06-26
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-07-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118047
  • 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
    Sterilant, medical devices - Product Code MED
  • 원인
    During a routine label review, the firm identified four system 1e quick connects that will be updated to reflect the removal of obsolete device models. this labeling review process also highlighted the opportunity to combine two existing quick connects into a single product while eliminating the obsolete models.
  • 조치
    STERIS sent a Customer Notification letter dated February 19, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to replace their existing labels with labels they provided in their customer notification package. We apologize for any inconvenience this may have caused you and as always STERIS Corporation is dedicated to support our products and valued Customers. If you have any questions regarding this matter, please contact your STERIS Capital Account Manager. For further questions please call (440)392-7348

Device

Device Recall Quick Connect
  • 모델명 / 제조번호(시리얼번호)
    LOT NUMBERS: QLC1677E: 1986157 - 2740157; QRC1699E: 1953884- 3376282 & QPC1721E/ QFC1683E: 3809423-Q001121.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution including the states of AK, AZ, CA, CO, FL, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI and WY.
  • 제품 설명
    Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 || QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart and a flow unit. The flow unit consists of a Quick Reference Card, tubing, tethers and adapters for connecting specified devices to Flexible Processing Trays/Containers.
  • Manufacturer
    Steris Corporation

Manufacturer

Steris Corporation
  • 제조사 주소
    Steris Corporation, 5960 Heisley Rd, Mentor OH 44060-1834
  • 제조사 모회사 (2017)
    Steris Corporation
  • Source
    USFDA