Events

Device Recall Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating 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
    50223
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0980-2009
  • 사례 시작날짜
    2008-11-10
  • 사례 출판 날짜
    2009-02-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2009-11-25
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=75002
  • 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
    Stent, ureteral - Product Code FAD
  • 원인
    "soft" stents were placed in "firm" stent outer boxes. the soft stent is only to be left in the patient for 6 months, but the firm stent can be left in the patient for 12 months, so this error could result in the stent being left in the patient for longer than indicated for the device.
  • 조치
    Consignees were notified via recall letter, "Urgent: Recall Notice" dated November 10, 2008, and by follow-up phone call. Customers were instructed to isolate the recalled product, complete the enclosed form and fax to Cook Urological at 812-829-2353. After receipt of the completed form, Cook Urological will issue a Return Goods Authorization number for each customer to return the affected product to Cook Urological via FedEx or UPS.

Device

Device Recall Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: U1753668.
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution including states of Georgia, Oregon and Texas.
  • 제품 설명
    Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/26cm, sterile, Cook Urological Inc., Spencer, IN; REF USH-526-R, GPN REF G49966. The product was placed in a shipping box which is preprinted with the word "firm" instead of "soft", but a product specific label stating "soft", as above, was also placed on the box. || The ureteral stent is used for temporary 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