Events

Device Recall OTO EASE 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Westone 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
    62520
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2058-2012
  • 사례 시작날짜
    2012-07-13
  • 사례 출판 날짜
    2012-07-20
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-12-14
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=110825
  • 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
    Lubricant, patient - Product Code KMJ
  • 원인
    Westone is recalling all oto ease ear lubricant in all packaging configurations and sizes due to potential microbial contamination of the product.
  • 조치
    Westone Laboratories sent an Urgent Recall letter and Press Release to distributors and customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to immediately examine their inventory, quarantine product subject to recall and discard or return the product to Westone. In addition, if the affected product have been further distributed please identify your customers and notify them at once of this product recall. Consumers with questions may contact Westone Laboratories at 1-800-357-3240 between the hours of 8:00am and 5:00pm MST or email at otoeaserecall@westone.com.

Device

Device Recall OTO EASE
  • 모델명 / 제조번호(시리얼번호)
    Individual products are not identified with lot numbers. There may be lot numbers on the bottom of the bulk packaging of a twelve pack of individual products but the end user may not be aware of a lot number for the specific vial. No expiry is applied to the finished products.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    Worlwide Distribution - US (nationwide) and to countries of: Australia, Belgium, Brazil, Canada, France, Germany, Greece, Hong Kong, Ireland, Japan, Korea, Mexico, Panama, Philippines, Russian Federation, and Singapore, Sweden, Switzerland and Thailand and United Kingdom.
  • 제품 설명
    Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold in 0.5 oz consumer sized semi transparent flexible plastic bottles. || Product Usage: || The product is used as a patient lubricant which eases insertion of earmolds and hearing instruments such as hearing aids.
  • Manufacturer
    Westone Laboratories, Inc.

Manufacturer

Westone Laboratories, Inc.
  • 제조사 주소
    Westone Laboratories, Inc., 2235 Executive Cir, Colorado Springs CO 80906-4137
  • 제조사 모회사 (2017)
    Westone Laboratories Inc.
  • Source
    USFDA