Evergreen 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Unomedical 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
    53489
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0044-2010
  • 사례 시작날짜
    2009-10-06
  • 사례 출판 날짜
    2009-11-04
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2010-08-10
  • 사례 출처
    USFDA
  • 사례 출처 URL
  • 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
    Manual Pulmonary Resuscitator - Product Code BTM
  • 원인
    In some manual pulmonary resuscitator units the duckbill valve and retention ring inside the patient valve housing may become dislodged and fall into the mpr bag/body. if this occurs, the mpr may lose its ability to generate the positive pressure necessary necessary to ventilate the patient.
  • 조치
    Unomedical issued Press on October 6, 2009. Letters were sent to customers on October 7, 2009 via UPS - return receipt. Letters explained the reason for recall and the potential hazard to patients. The letter contains a list of all affected lot numbers as well as a picture which shows that units with a clearly visible blue ring are NOT affected. Distributors are asked to examine inventory and quarantine all affected product and return the response form, even if no recalled product is in inventory. If the product was further distributed, the letter requests that a copy of the letter be sent to all customers and for returns, follow Distributor actions listed in the letter. Retailers and end users/Hospitals/EMT's are asked to perform a count of recalled product, segregate it and return the response form. All customers are asked to call 1-800-634-6003 where they will be assigned a RGA number and given instructions on how to return product. Contact information: 8:00AM - 5:30 PM Central Time Monday through Thursday and 8:00AM to 1:00 PM on Fridays, Central Time.

Device

  • 모델명 / 제조번호(시리얼번호)
    Product # 12-8705; lot numbers: 04-51
  • 의료기기 분류등급
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution: USA, Argentina, Canada, Denmark, France, Greece, India, Italy, Japan, Mexico, Paraguay, Peru, Poland, Russia and Vietnam.
  • 제품 설명
    Manual Pulmonary Resuscitator, Adult w/ Large Adult Mask & Reservoir Bag. Product # 12-8705. || Packaged under the name of Evergreen.
  • Manufacturer

Manufacturer

  • 제조사 주소
    Unomedical, 5701 S Ware Rd, Mcallen TX 78503-7795
  • 제조사 모회사 (2017)
  • Source
    USFDA