Events

UroSeal Adjustable Endoscopic Valve 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 US Endoscopy Group Inc 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
    69809
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0861-2015
  • 사례 시작날짜
    2014-10-31
  • 사례 출판 날짜
    2014-12-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-06-01
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131574
  • 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
    Endoscope and/or accessories - Product Code KOG
  • 원인
    Packaging non-conformance related to the integrity of the sterile pouch seal.
  • 조치
    Consignees were notified by phone, e-mail, and an Urgent: US Endoscopy UroSeal Adjustable Valve Recall letter. The letter identified the affected product and the reason for the recall. Customers were asked to remove any affected product from their inventory and quarantine them. Additionally, customers were to complete and return the attached Customer Response Card to Kia Pennington via fax at 1-440-639-4495 or e-mail at recall@usendoscopy.com as soon as possible. The firm contacted customers regarding the RMA instructions and replacement product. Customers were to follow the RMA instructions in order to receive an RMA number and return the affected product. Questions should be directed towards Kia Pennington in Customer Service at 1-800-769-8229.

Device

UroSeal Adjustable Endoscopic Valve
  • 모델명 / 제조번호(시리얼번호)
    Lot 1417696
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Distributed to the states of FL, MO, OH and WI.
  • 제품 설명
    UroSeal Adjustable Endoscopic Valve. Model/Catalog # 00913410 || The primary packaging is a Tyvek pouch. The secondary package is a corrugate box. 5 units per box. || Used to cover the opening to the biopsy/suction channel of an endoscope.
  • Manufacturer
    US Endoscopy Group Inc

Manufacturer

US Endoscopy Group Inc
  • 제조사 주소
    US Endoscopy Group Inc, 5976 Heisley Rd, Mentor OH 44060-1873
  • 제조사 모회사 (2017)
    Steris Plc
  • Source
    USFDA