Events

Device Recall Pall "TNA1" Total Nutrient Admixture Filter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Pall Life Sciences Puerto Rico Llc 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
    59174
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2715-2011
  • 사례 시작날짜
    2011-06-15
  • 사례 출판 날짜
    2011-06-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-01-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=101496
  • 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
    Filter, infusion line - Product Code FPB
  • 원인
    Incorrect filter media used (0.2 um filter used instead of the required 1.2 um) within the tna1 filter used with total parenteral nutrition mixtures.
  • 조치
    Pall Life Sciences LLC, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 15, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructed customers to maintain the product in quarantine. If distributed, the letter request that customers notify the user to discontinue use. Additionally, customers were asked to complete and return an attached Recall Response Form. The letter also included instructions on how to return the product. Please contact the Customer Service Department at 516-801-9923, if you have questions.

Device

Device Recall Pall "TNA1" Total Nutrient Admixture Filter
  • 모델명 / 제조번호(시리얼번호)
    Exp. date 2015-07: Lots 032711, 032811, 033611 and 033711 Exp. date 2016-01: Lots 105912 and 106012
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution--USA (nationwide) including the states of CA, CO, CT, IL, KS, LA, MA, MO, MS, NC, NY, OK, SD, TX, WA, and WY, and Puerto Rico and the countries of Colombia and Costa Rica.
  • 제품 설명
    Pall Total Nutrient Admixture Filter, 1.2 micron filter || This filter is a 1.2 micron low protein binding membrane indicated for the removal of inadvertent particulate debris and microorganisms (Candida Albicans) from total nutrient admixtures and undiluted intravenous fat emulsions. Product is designed for use with intravenous infusion pumps only.
  • Manufacturer
    Pall Life Sciences Puerto Rico Llc

Manufacturer

Pall Life Sciences Puerto Rico Llc
  • 제조사 주소
    Pall Life Sciences Puerto Rico Llc, Pall Blvd 99 & 100, Rd 194, Km 0.4, Fajardo PR 00738
  • 제조사 모회사 (2017)
    Danaher Corporation
  • Source
    USFDA