Events

PovidineIodine prep solution/Providine prep pads 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Custom Medical Specialties, 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
    62132
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-2356-2012
  • 사례 출판 날짜
    2012-09-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2013-04-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111523
  • 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
    General surgery tray (kit) - Product Code LRO
  • 원인
    The firm saw on the fda web site a recall by the manufacturer of the povidone iodine prep solution due to no microbial testing and product did not meet proper finished goods specifications.
  • 조치
    Custom Medical Specialties sent an Urgent Medical Device Recall letter dated September 27, 2011 and a follow-up letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem, and actions to be taken. The letter requested that customers inspect inventory, discontinue use and return any remaining affected products. A Return Authorization Number and shipping number will be given to customer by calling 919-202-8462 ext 205. Customers were instructed to complete and return the attached Acknowledgement and Return Product form.

Device

PovidineIodine prep solution/Providine prep pads
  • 모델명 / 제조번호(시리얼번호)
    15924-0906, 16975-0910, 17709-0912
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    US Nationwide Distribution including the states of CO, FL, KS, MA, MI, NJ and PA.
  • 제품 설명
    CMS-8495-R5 Custom Vein Tray containing 4 oz. bottle PVP Prep Solution || Product Usage: Usage: || The PVP contained in the kit is used in skin prep
  • Manufacturer
    Custom Medical Specialties, Inc.

Manufacturer

Custom Medical Specialties, Inc.
  • 제조사 주소
    Custom Medical Specialties, Inc., 330 East Main Street, Pine Level NC 27568
  • Source
    USFDA