Events

Steris Quick Connects (QC) QFC1728 and QFC1729 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Steris Corporation Hopkins Facility 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
    44810
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0101-2008
  • 사례 시작날짜
    2007-09-12
  • 사례 출판 날짜
    2007-10-24
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-09-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64407
  • 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
    Steris Quick Connects - Product Code MED
  • 원인
    Loose or missing adaptor: the center insert of the adaptor #6 restrictor could become loose and/or come out of the adaptor's housing. the absence of adaptor #6's center insert may affect the sterilization process of the attached endoscope.
  • 조치
    STERIS has contacted affected direct accounts by phone to notify direct accounts of the recall. On 9/28/2007, STERIS will mail a recall notification to all affected direct accounts via certified mail. The notification informs direct accounts that STERIS representatives will be visiting direct accounts to retrieve affected products and provide replacements. Where direct accounts further distribute, STERIS representatives will inform the direct accounts to contact their sub-accounts and facilitate exchange of affected product for replacement product. Replacement product will be available beginning November 1, 2007.

Device

Steris Quick Connects (QC) QFC1728 and QFC1729
  • 모델명 / 제조번호(시리얼번호)
    C041782, C041793, 3072287, C041514, C041512, C041508, C041513, C041515, 3072303, 3290749, 3338126, C041781, C041794, 3072246, C041506, C041509, C041510, C041511, 3072261, 3290723, 3318292, 3338100, 3352374, 3542412, 3643871, 3546157, 3656121, 3893160, 3890027, 3748456, 3930062, 3978731, 3342342, 3352390, 3575941, 3643897, 3668357, 3895661, 3900198
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide: United States, Australia, Bahrain, Canada, Germany, Great Britain, Hungary, Italy, Qatar, and Spain
  • 제품 설명
    Steris QFC1728 and QFC1729 Quick Connects;(used to connect gastrointestinal endoscopes to processing trays) The malfunctioning piece of the quick connect component is adaptor #6, STERIS part number 201158. Adaptor #6 attaches to the suction port of the endoscope.
  • Manufacturer
    Steris Corporation Hopkins Facility

Manufacturer

Steris Corporation Hopkins Facility
  • 제조사 주소
    Steris Corporation Hopkins Facility, 6515 Hopkins Rd, Mentor OH 44060-4307
  • 제조사 모회사 (2017)
    Steris Plc
  • Source
    USFDA