Events

Device Recall Renasys EZ PLUS 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Smith & Nephew 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
    66893
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1068-2014
  • 사례 시작날짜
    2013-11-14
  • 사례 출판 날짜
    2014-02-21
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-08-04
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=124060
  • 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
    wound therapy system - Product Code OMP
  • 원인
    Modification of the bacterial overflow guard (filter) and related changes to product labeling.
  • 조치
    The correction strategy is as follows: " An Urgent Medical Device Correction Notice has been prepared to be distributed to all US consignees via Federal Express delivery for confirmation of the delivery. " A copy of the Urgent Medical Device Correction Notice is to be posted on Smith & Nephew's websites, URL corporate, http://www.smith-nephew.com/news-and-media/, and myrenasys.com, concurrent with the distribution of the Notice to consignees. " US distribution of the original design of Canister Kits codes (66800912, 66800913, 66801066, 66800423 and 66800058) subject to this correction ceased November 1, 2013. " The correction has been implemented on a change being affected basis. The modified design is being distributed to US customers effective November 1, 2013. No product will be removed from the market. " Periodic progress reports to FDA, as required per 21 CFR 806 will be submitted monthly until completion of the correction actions..

Device

Device Recall Renasys EZ PLUS
  • 모델명 / 제조번호(시리얼번호)
    Product code:  66800912 - 800ml canister with solidifier 66800913 - 250ml canister with solidifier 66801066 - 800ml canister without solidifier 66800423 - 800ml canister with solidifier 66800058 - 250ml canister with solidifier Lot codes - M201498 thru M400299
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: USA (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KY, LA, MA, MI, MN, MO, MS, MT, NC, NH, NV, NY, OH, OR, PA, RI, SC, SD, TN, TX, VA, WA, WV, and Puerto Rico; and the countries of: Austria, Australia, Belgium, Switzerland, China, Cyprus, Germany, Denmark, Spain, Finland, France, UK, Greece, Israel, Italy, Malta, Netherlands, Norway, Paraguay, Russia, Saudi Arabia, Sweden, Thailand, Turkey, South Africa, Mexico, and Canada.
  • 제품 설명
    Renasys EZ PLUS, a Canister Component of of Renasys EZ Negative Pressure Wound Therapy System
  • Manufacturer
    Smith & Nephew Inc.

Manufacturer

Smith & Nephew Inc.
  • 제조사 주소
    Smith & Nephew Inc., 970 Lake Carillon Dr, Ste 110, Saint Petersburg FL 33716-1130
  • 제조사 모회사 (2017)
    Smith & Nephew plc
  • Source
    USFDA