Events

Device Recall OtherSonic Generic Ultrasound Transmission Gel 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Pharmaceutical Innovations, 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
    61732
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-1652-2012
  • 사례 시작날짜
    2012-03-02
  • 사례 출판 날짜
    2012-05-24
  • 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=108812
  • 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
    Media,coupling,ultrasound - Product Code MUI
  • 원인
    Other-sonic generic ultrasound transmission gel is being recalled due to possible microbial contamination. an fda safety communication was issued for this product on april 18, 2012.
  • 조치
    Phamaceutical Innovations Inc. sent an Urgent Message Notice letter dated March 02, 2012 with a followup letter dated March 9, 2012 and an Inventory Withdrawal letter dated March 23, 2012 via email and fax to all affected customers. Customers were instructed to examinne inventory, refrain from distribution and return remaining inventory for a replacement. For questions call 973-242-2900.

Device

Device Recall OtherSonic Generic Ultrasound Transmission Gel
  • 모델명 / 제조번호(시리얼번호)
    060111 080111 090111 100811
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - United States (nationwide) including the states of: FL, MA, MS, NJ, OH, TN and VA, and the countries of: Canada and Australia.
  • 제품 설명
    Other-Sonic Generic Ultrasound Transmission Gel 250 mL || Hypoallergenic || Product Usage is a non-sterile gel used in ultrasound procedures to improve the transmission of the ultrasound signal from the transducer to the body.
  • Manufacturer
    Pharmaceutical Innovations, Inc.

Manufacturer

Pharmaceutical Innovations, Inc.
  • 제조사 주소
    Pharmaceutical Innovations, Inc., 897 Frelinghuysen Ave, Newark NJ 07114-2122
  • 제조사 모회사 (2017)
    Pharmaceutical Innovations Inc
  • Source
    USFDA