Events

Device Recall Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Teleflex Medical Europe Ltd 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
    79670
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1403-2018
  • 사례 시작날짜
    2018-03-27
  • 사례 출판 날짜
    2018-04-17
  • 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=162940
  • 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
    Connector, airway (extension) - Product Code BZA
  • 원인
    These one-way valves may disconnect at the joint between the two components that make up the device, which would cause an interruption of ventilation to the patient.
  • 조치
    Teleflex initiated the recall by letter on 03/27/2018. The firm directed the consignee as follows: "1. If you have affected stock, immediately discontinue use and quarantine any products with the product code and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document your receipt of this letter."

Device

Device Recall Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port
  • 모델명 / 제조번호(시리얼번호)
    Lot Numbers: 74D1501706 74K1502092 74F1600367 74J1600117 74L1601916 74C1701733 74F1700707 74D1501731 74K1502045 74F1601072 74J1601101 74M1600284 74C1702365 74F1701866 74G1500664 74M1501145 74F1601874 74J1601563 74M1601685 74D1700030 74F1702612 74G1500663 74A1601936 74F1602470 74J1602238 74A1700107 74D1700363 74G1700034 74G1502412 74B1600334 74G1600466 74K1600148 74A1701335 74D1701038 74G1700488 74H1500466 74C1600162 74H1600217 74K1600287 74A1701403 74D1701507 74G1701144 74H1500189 74D1601420 74H1600516 74K1601020 74A1702060 74E1700450 74G1702002 74H1501260 74D1601965 74H1601371 74K1601924 74A1702874 74E1700965 74H1700127 74H1501971 74E1600800 74H1601372 74L1600063 74B1701032 74E1701630 74H1700791 74J1501554 74E1601571 74H1602060 74L1600278 74B1700172 74E1702399 74H1701752 74K1500354 74E1600116 74H1602061 74L1601099 74C1700868 74F1700125 74H1702374
  • 의료기기 분류등급
    Anesthesiology Devices
  • 의료기기 등급
    1
  • 이식된 장치?
    No
  • 유통
    US Nationwide in the states of AU, CA, NZ
  • 제품 설명
    Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644, QTY 50 || Product Usage: || for use in respiratory and anesthesia circuits to connect two or more components of a breathing system.
  • Manufacturer
    Teleflex Medical Europe Ltd

Manufacturer

Teleflex Medical Europe Ltd
  • 제조사 주소
    Teleflex Medical Europe Ltd, Ida Business Park, Athlone Ireland
  • 제조사 모회사 (2017)
    Teleflex Incorporated
  • Source
    USFDA