Events

LeMaitre VascuTape Radiopaque Tape 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Lemaitre Vascular, 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
    57028
  • 사례 위험등급
    Class 3
  • 사례 연번
    Z-0434-2011
  • 사례 시작날짜
    2010-10-22
  • 사례 출판 날짜
    2010-11-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-09-15
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95207
  • 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
    Measuring Tape, Rulers and Calipers - Product Code FTY
  • 원인
    Box label (top part). lot and expiration date information were switched.
  • 조치
    Lemaitre Vascular notified customers by an Urgent: VascuTape Radiopaque Tape Device Field Safety Notice letter on 10/22/10 via USPS with delivery confirmation. The Notice advised users of the incorrect lot and lot number on the outer box and also provided an image of the box and label for ease in identifying the product in their inventory. The letter states that the use and functionality of the device are not affected by the problem; however, if customers feel uncomfortable continuing to use the affected device, they can contact Customer Service for replacement. The firm recommended discarding the outer box of the affected product. The letter contains a form that is requested to be returned to LeMaitre Vascular as record of notification and reconciliation. Accounts can contact customer service at 800-628-9470.

Device

LeMaitre VascuTape Radiopaque Tape
  • 모델명 / 제조번호(시리얼번호)
    Lot Number: LSG1109 Exp Date: 2015-06
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution -- AL, CA, CT, IL, ME, MI, MS, NC, NJ, NY, PA, PR, TX, and WA.
  • 제품 설명
    LeMaitre VascuTape Radiopaque Tape, LeMaitre Stent Guide, 100 strips || Catalog Number: 1102-00 || Intended to be placed on the patient's skin to assist during imaging procedures by serving as an internal frame of reference.
  • Manufacturer
    Lemaitre Vascular, Inc.

Manufacturer

Lemaitre Vascular, Inc.
  • 제조사 주소
    Lemaitre Vascular, Inc., 63 2nd Ave, Burlington MA 01803-4413
  • Source
    USFDA