Events

Device Recall CORTRAK 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes w/ ANTIIV Connector 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Halyard Health, 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
    79479
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1277-2018
  • 사례 시작날짜
    2017-12-13
  • 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=162433
  • 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
    Filter, infusion line - Product Code FPB
  • 원인
    The transmitting stylet within cortrak* 2 nasogastric/nasointestinal (ng/ni) feeding tubes with anti-iv* connector (product code 20-9551trak2a) may be visible within the window of the exit port of the feeding tube. based on specifications, the transmitting stylet in the ng tube should not be visible within the port window.
  • 조치
    The firm, Halyard, sent an "URGENT: Product Advisory Notice" letter dated 12/13/2017 to its customers on about 12/13/2017. The letter described the product, problem and actions to be taken. The Customers were instructed to do the following: Instructions for distributors included to examine unsold inventory for impacted lots, complete and return the Distributor Product Advisory Notice Acknowledgement Form, and send the attached End-User/Customer Product Advisory Notice and Acknowledgement Form to all end user customers who would have potentially received impacted product by email to: monica.king@hyh.com or by FAX to: 678-254-0347. A Halyard Customer Service Representative will contact the distributors if affected product was on hand. Instructions for End-User/Customers included to evaluate the clinical facility's unused inventory for impacted lots, inform all clinicians in the facility who may use potentially impacted devices to verify that the stylet tip is not visible within the window of the exit port after engaging the stylet with the port connector of the NG/NI Feeding Tube, and if it is visible, do not use the device. Additionally they were asked to complete and return the Product Advisory Notice Acknowledgement Form by email to: monica.king@hyh.com or by FAX to: 678-254-0347. If you require further assistance, please call Halyard Regulatory Affairs at 678-477-4165. You may also contact Halyard Customer Service at 1-844-HALYARD (1-844-425-9273, OPTION 1, OPTION 3).

Device

Device Recall CORTRAK 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes w/ ANTIIV Connector
  • 모델명 / 제조번호(시리얼번호)
    Product code 20-9551TRAK2A, Lot No. 7909, 7839, 7876.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution: US (nationwide) to states of: AR, CA, CO, GA, IA, LA, MI, MN, NM, TX; and country of Germany. Distributed internationally to Germany.
  • 제품 설명
    CORTRAK* 2 Nasogastric/Nasointestinal (NG/NI) Feeding Tubes with Electromagnetic Transmitting Stylet and CORFLO* Enteral Feeding tube, ANTI-IV* Connector, 10 Fr, 140 cm || The device is used in patients that require intermittent or continuous tube feedings via the nasogastric or nasoenteric route.
  • Manufacturer
    Halyard Health, Inc

Manufacturer

Halyard Health, Inc
  • 제조사 주소
    Halyard Health, Inc, 5405 Windward Pkwy, Alpharetta GA 30004-3894
  • Source
    USFDA