Device Recall Hudson RCI One Way Valve 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Telefelx Medical 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
    53960
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0652-2010
  • 사례 시작날짜
    2009-12-02
  • 사례 출판 날짜
    2010-01-15
  • 사례 상황
    Terminated
  • 사례 국가
  • 사례 종료 날짜
    2010-08-11
  • 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
    Airway connector (Extension) - Product Code BZA
  • 원인
    Products 1664 and 1665 are each one-way valves that offer low flow resistance, each in one, opposite direction. each of these valves demonstrate the appropriate direction with a red arrow. the reason for this recall is incorrect packaging; product code 1664 was incorrectly packaged as product code 1665. if the red arrows are not followed, the valve may be placed in the circuit in the wrong.
  • 조치
    Consignees were notified by letter via next day delivery. Each consignee was sent a letter requesting acknowledgement of the recall and a request to return all of the affected product. Each consignee that is a distributor was instructed to forward the letter to their consignees to retrieve relevant product from those locations. A second mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the second mailing or as an alternative, they may be contacted by phone, e-mail, or fax. A record of these contacts will be maintained. Affected products received by Teleflex will be destroyed or reworked and replacement product or credit will be provided to the consignees. Records of destruction or rework will be maintained. Questions are directed to the firm's sales representatives or to Teleflex Customer Service at 1-866-246-6990

Device

  • 모델명 / 제조번호(시리얼번호)
    Catalog number: 1665, Lot number: 02J0901967
  • 의료기기 분류등급
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    CA, IL, NE, NJ, TX, VA, WI and Canada.
  • 제품 설명
    Hudson RCI One Way Valve, 22mm E.D. to 22mm O.D., REF 1665, Rx Only, Teleflex Medical, Research Triangle park, NC 27709
  • Manufacturer

Manufacturer

  • 제조사 주소
    Telefelx Medical, 2917 Weck Drive, Durham NC 27709
  • 제조사 모회사 (2017)
  • Source
    USFDA