Events

PVC Trocar Thoracic Catheters 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Atrium Medical Corporation 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
    75347
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0576-2017
  • 사례 시작날짜
    2016-10-26
  • 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=150103
  • 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
    Catheter, cholangiography - Product Code GBZ
  • 원인
    Trocar catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.
  • 조치
    Atrium Medical issued an "Urgent Medical Device Recall (Removal)" communication to customers on 10/26/16 via FedEx 2 day delivery. The recall identifies the problem, product, and risk factors. In addition, it provides instructions on how to handle product that may be affected. Accounts are to read the letter completely and share with all users and staff. They have been requested to complete the enclosed Recall Reply Form, acknowledging receipt of the notice; and, remove and quarantine any affected product for return. Additionally, obtain product from an alternate supplier because replacement product is not available as all Trocar catheters have been discontinued. Contact Atrium Medical Customer Service at 1-800-370-7899, Monday through Friday between 9:00 am to 5:00 pm, for a Return Goods Authorization to return the product and receive credit.

Device

PVC Trocar Thoracic Catheters
  • 모델명 / 제조번호(시리얼번호)
    All lot codes
  • 의료기기 분류등급
    General and Plastic Surgery Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.
  • 제품 설명
    Atrium Medical 32 Fr Trocar catheter, Sterile || Model Number: 8432 || Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.
  • Manufacturer
    Atrium Medical Corporation

Manufacturer

Atrium Medical Corporation
  • 제조사 주소
    Atrium Medical Corporation, 5 Wentworth Dr, Hudson NH 03051-4929
  • 제조사 모회사 (2017)
    Getinge AB
  • Source
    USFDA