Events

AngioDynamics VenaCure EVLT Procedure Kits 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Angiodynamics, 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
    65119
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1406-2013
  • 사례 시작날짜
    2013-04-30
  • 사례 출판 날짜
    2013-05-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-11-09
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=117930
  • 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
    Powered laser surgical instrument - Product Code GEX
  • 원인
    Angiodynamics inc., is recalling micro introducer kits and venacure evlt nevertouch procedure kits, because the potential exists that the micro introducer (sheath/dilator) packaged within the kit could be the wrong french size.
  • 조치
    AngioDynamics sent an Urgent Medical Device Recall letter dated April 29, 2013, to all customers by Fed Ex. The letter identified the affected product, problem and actions to be taken. Customers were instructed to lmmediately remove the affected product from inventory and call AngioDynamics, Inc. Customer Service at 1-800-772-6446 to obtain a replacement or credit for your returned product and to obtain UPS Account Number to return the package via second day delivery. Customers are instructed to segregate and return all affected devices to: AngioDynamics 603 Queensbury Avenue Queensbury, NY 12804 Attn: Micro Introducer and VenaCure EVLT NeverTouch Procedure Kits Recall Coordinator. Write the RMA number on the shipping box (Provied on the Recall Verification Tracking Form). Promptly complete, sign and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on the notification form and the Reply Verification Form. Send the Reply Verification form to AngioDynamics either via Fax or Emai. Fax Reply Verification Tracking Form to: Attn: Micro Introducer and VenaCure EVLT NeverTouch Procedure Kits Recall Coordinatory Fax number 1-518-798-1360 or Email Reply Verification Tracking Form to: rdenino@angiodynamics.com.

Device

AngioDynamics VenaCure EVLT Procedure Kits
  • 모델명 / 제조번호(시리얼번호)
    Corresponding Lot numbers: 1) 588948, 2) 588495 and 3)588480. Expiration date for these lot numbers: 12/2013.
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    USA Nationwide Distribution including the states of: IL, GA, CA, NY OH, AZ, TX, NE, FL, PA, NC, WI, AL, IN, CO, MO, MT, NE, MA, VA, AK, IN, MI, NJ, MD, TN, CT, WA, MN
  • 제품 설명
    AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: || 1) Gold-Tipped Fiber 45cm Kit, Catalog Number: 11403301; 2) Gold-Tipped Fiber 65cm Kit, Catalog Number: 11403302; 3) Gold-Tipped Fiber 90cm Kit, Catalog Number: 11403304. || Product Usage: || This device is intended to be used to measure the refractive power and the radius of corneal curvature of the human eye.
  • Manufacturer
    Angiodynamics, Inc.

Manufacturer

Angiodynamics, Inc.
  • 제조사 주소
    Angiodynamics, Inc., 603 Queensbury Ave, Queensbury NY 12804-7619
  • 제조사 모회사 (2017)
    AngioDynamics Inc
  • Source
    USFDA