Events

BiPolar Vaporization Electrodes 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Richard Wolf Medical Instruments Corp. 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
    66457
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0145-2014
  • 사례 시작날짜
    2013-09-18
  • 사례 출판 날짜
    2013-11-04
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-04-24
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122427
  • 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
    Resectoscope - Product Code FJL
  • 원인
    Richard wolf medical instrument corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch.
  • 조치
    The firm, Richard Wolf, sent an "Urgent: Medical Device Recall" letter dated September 16, 2013, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to inspect their inventory of vaporization electrodes from lot 426111, contact Richard Wolf Medical Instrument Corporation at 800-323-9653 x 344 or ext 225 or ext. 380 to inform Richard Wolf Medical Instrument Corporation if the customer has or does not have any devices from this lot, return the affected devices with the return authorization provided by Richard Wolf Medical Instrument Corporation for credit, and complete and return the attached Recall Response form via fax to: 847-913-0924; email: dclark@richardwolfusa.com; or mailed to: Richard Wolf Medical Instrument Corporation, 353 Corporate Woods Parkway, Vernon Hills, IL 60061-3110. Customers who require urgent replacement of the affected devices can contact their customer service representative for replacement. If you have any questions, call 800-323-9653 x 344.

Device

BiPolar Vaporization Electrodes
  • 모델명 / 제조번호(시리얼번호)
    *** Individual Units ***  Product Code: 4630022 (single);  Lot: 426111;  Expiration Date: 2016/06;  *** Cartons ***  Product Code: 46300223 (box of 3);  Lot: 426111;  Expiration Date: 2016/06;
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide distribution: US including states of: CA, GA, IL, KY, LA, MI, MD, NY, OR, TX, VA and Puerto Rico.
  • 제품 설명
    Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr.; LOT 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF; || Cartons of 3 units labeled in part: REF 46300223; Vaporization electrode, sterile; 4mm telescope 30/25/12; only for continuous irrigation sheath 24,5 Fr.; Lot 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF || S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium. It can also be used for monopolar resection if necessary.
  • Manufacturer
    Richard Wolf Medical Instruments Corp.

Manufacturer

Richard Wolf Medical Instruments Corp.
  • 제조사 주소
    Richard Wolf Medical Instruments Corp., 353 Corporate Woods Pkwy, Vernon Hills IL 60061-3110
  • 제조사 모회사 (2017)
    Richard Und Annemarie Wolf Stiftung
  • Source
    USFDA