Events

Device Recall CORFLO, PEG 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 CORPAK MedSystems, 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
    76465
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2162-2017
  • 사례 시작날짜
    2017-02-03
  • 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=155499
  • 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
    Tubes, gastrointestinal (and accessories) - Product Code KNT
  • 원인
    Firm is initiating voluntary correction of corflo peg with enfit. barb connector (stem) of the adapter may break unexpectedly when exposed to stress.
  • 조치
    Firm provided consignees with field correction on 2/2/2017 by letter mailed via FedEx. Within the notice, the firm provided additional instructions for handling the PEG Y-Adapter to help reduce the likelihood for exposing the stem to excess stress that could break the connector. Consignees were instructed to forward the field correction notice to all staff members or end-users who use the ENFit Y-Adapter.

Device

Device Recall CORFLO, PEG
  • 모델명 / 제조번호(시리얼번호)
    Catalogue Numbers: 50-6116
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide distribution in the states of NH, VT, CA and the countries of UK, Ireland, France, Austria, Norway, Sweden, New Zealand
  • 제품 설명
    CORFLO, PEG Adaptor Repair Kit with ENFit Connectors, Size: 16FR; || Product Usage: || CORFLO PEG Tubes are intended for delivery of enteral nutrition, water and medications into the stomach. The PEG adapter is the connection point between the tubing and the feeding set/syringe. The adapter is designed as a replaceable component.
  • Manufacturer
    CORPAK MedSystems, Inc.

Manufacturer

CORPAK MedSystems, Inc.
  • 제조사 주소
    CORPAK MedSystems, Inc., 1001 Asbury Dr, Buffalo Grove IL 60089-4528
  • 제조사 모회사 (2017)
    Halyard Health Inc
  • Source
    USFDA