Events

Universa Soft Ureteral Stent 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Vance Products Incorporated 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
    57352
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0852-2011
  • 사례 시작날짜
    2010-10-18
  • 사례 출판 날짜
    2011-01-05
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-07-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95928
  • 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
    Ureteral Stent - Product Code FAD
  • 원인
    The firm received a customer complaint that a box labeled as universa firm stents but the box actually contained universa soft stents. the inner product label is correct but the outer box is wrong.
  • 조치
    The firm sent URGENT: RECALL NOTICES dated 10/18/2010 to its direct accounts. The notice identified the affected product and instructed firms to pull the recalled product from stock and isolate it. Customers are to complete the form and e-mail or fax the form back to Cook. Product should be returned to the recalling firm using the Return Goods Authorization number. Cook Urological will credit customer accounts upon receipt of the returned product.

Device

Universa Soft Ureteral Stent
  • 모델명 / 제조번호(시리얼번호)
    Lot number: U1987598.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution -- USA, including states of WI, TX, NY, SC, AZ, TN, FL, AR, CA, AL, and WA and country of Canada.
  • 제품 설명
    Cook Medical, Universa Soft Ureteral Stent and positioner, 6 Fr x 24 cm, REF USH-624-R, sterile, Cook Urological, Inc., Spencer IN. || Used for temporary internal drainage from the ureteropelvic junction to the bladder.
  • Manufacturer
    Vance Products Incorporated

Manufacturer

Vance Products Incorporated
  • 제조사 주소
    Vance Products Incorporated, 1100 W Morgan St, Spencer IN 47460-9426
  • 제조사 모회사 (2017)
    Cook Group Incorporated
  • Source
    USFDA