Events

Device Recall bvi Beaver(R) Xstar(R) Safety Slit Knife 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Beaver-Visitec International 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
    78789
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0501-2018
  • 사례 시작날짜
    2017-11-03
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=160464
  • 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
    Knife, surgical - Product Code EMF
  • 원인
    The firm received 200 reports in which the protective shield was retracted.
  • 조치
    The firm disseminated their safety advisory notices on 11/03/2017 by email and visit. The letter identified the affected product, problem and actions to be taken. The firm requested the following action:"Prior to opening the Tyvek tray, please visually confirm that the plastic shield is not retracted and the activation slider is fully engaged."

Device

Device Recall bvi Beaver(R) Xstar(R) Safety Slit Knife
  • 모델명 / 제조번호(시리얼번호)
    (a) REF 378210,1.0mm, 45o; Batch numbers:  3180424 3182237 3184226 3184813 3186254 3186824 3188328 3188645 3190859 3193382 3194781 3196464 3198432 3198854 3199803 3200529 3201366 3202916 3204378 3206693 3205820 3207400 3208145 3208991 3210483 3211178 3212699 3213363 3214566 3215756 3216416 3216492 3218692 3219548 3221087 3222870 3223305 3224266  (b) REF 378212, 1.2mm, 45o; Batch numbers:  3199656 3203358 3206699 3209859 3214567 3219440 3221088 3222865  (c) REF 378231, 115mm, 45o; Batch numbers:  3178327 3179276 3178796 3179272 3180593 3180598 3181976 3182464 3182639 3182046 3183235 3183238 3184099 3184963 3185053 3185244 3186410 3186412 3187088 3187093 3187750 3187757 3188489 3188491 3188618 3189330 3189784 3190033 3190105 3189326 3188579 3190848 3190550 3191722 3191724 3191726 3192143 3192150 3193378 3193381 3194674 3194105 3194681 3194685 3195697 3195871 3196693 3196857 3196858 3197676 3197678 3197729 3197690 3197730 3198018 3198103 3198441 3198699 3198942 3198946 3199082 3199212 3199932 3200397 3200399 3201332 3201334 3201955 3202086 3202525 3202914 3203451 3203455 3204179 3204183 3204291 3204838 3204978 3204981 3205769 3205725 3205773 3206384 3206387 3206533 3207239 3207242 3207374 3208034 3207870 3208031 3208913 3208978 3208982 3209712 3209823 3209855 3210584 3209864 3210258 3210260 3210969 3210972 3211747 3211750 3211761 3212793 3212807 3212803 3213019 3213022 3213346 3213571 3213574 3213577 3214981 3214554 3216350 3216491 3216491 3215759 3215871 3216488 3216489 3216487 3216500 3218555 3218686 3218689 3216501 3219034 3219304 3220070 3220071 3221089 3221090 3221696 3221698 3221772 3222620 3222623 3223345 3223800 3223815 3223255 3223299 3223340
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - US Nationwide and the countries of Italy, UK, Finland, Germany, Ireland, Turkey
  • 제품 설명
    bvi Beaver(R)Safety Sideport Knife: || (a) 1.0mm, 45o, REF 378210 || (b) 1.2mm, 45o, REF 378212 || (c) 115mm, 45o, REF 378231 || Product Usage: || Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
  • Manufacturer
    Beaver-Visitec International Inc.

Manufacturer

Beaver-Visitec International Inc.
  • 제조사 주소
    Beaver-Visitec International Inc., 411 Waverley Oaks Rd Ste 229, Waltham MA 02452-8422
  • 제조사 모회사 (2017)
    Tpg Capital Management L.P.
  • Source
    USFDA