Events

Sterile Aquasonic 100 Ultrasound Transmission Gel 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Parker Laboratories, 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
    79910
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1777-2018
  • 사례 시작날짜
    2017-04-13
  • 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=163914
  • 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
    System, imaging, pulsed echo, ultrasonic - Product Code IYO
  • 원인
    There is a potential for the gel packets to have leaks in the packet seal.
  • 조치
    Notification letters distributed 4/13/17 instructed customers to perform the following: We request that you quarantine any affected product in your inventory and contact Parker to discuss options for disposition of the recalled products in question. Should you identify any customers to whom the affected product may have already been distributed, we would be happy to provide you with a customer letter that can be transcribed onto your own company letterhead for the purposes of notifying them of this quality issue. Please completed the attached response form as soon as possible and return it to us at the email or fax number listed on the form, so that further arrangements can be made.

Device

Sterile Aquasonic 100 Ultrasound Transmission Gel
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: L0117006, L0117007, L0217001, L0217002, L0217004, L0217006
  • 의료기기 분류등급
    Radiology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    The products were distributed to the following US states: CA, FL, GA, IA, IL, OH, TN, and VA. The products were distributed to the following foreign countries: Canada, United Kingdom, and Malta.
  • 제품 설명
    Sterile Aquasonic 100 Ultrasound Transmission Gel, 20 grams, Model Number 01-01-4, 400 packets/case
  • Manufacturer
    Parker Laboratories, Inc.

Manufacturer

Parker Laboratories, Inc.
  • 제조사 주소
    Parker Laboratories, Inc., 286 Eldridge Rd, Fairfield NJ 07004-2509
  • 제조사 모회사 (2017)
    Parker Laboratories Inc
  • Source
    USFDA