Events

Device Recall 9.6F Plastic Dignity MidSized CT port w/PreAttached Silicone Catheter 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medical Components, Inc dba MedComp 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
    76625
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1536-2017
  • 사례 시작날짜
    2017-02-23
  • 사례 출판 날짜
    2017-03-08
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2018-02-02
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=153698
  • 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
    Port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
  • 원인
    The 9.6f port kits were packaged with the incorrect valved peelable introducer. the label states the kit contains a 10f valved peelable introducer. the kit is packaged with a 9f valved peelable introducer. the port lumen will not fit through the introducer during the insertion procedure.
  • 조치
    Medcomp mailed a Customer Notification letter dated February 23, 2017, to all affected customers to inform them of the issue. Customers were asked to examine their inventory and return all unused product. Distributors were also asked to locate the end user/facility of where the affected product was sold and communicate the recall to them. Customers were instructed to contact their customer service representative for a Returned Goods Authorization (RGA) number if necessary at 215-256-4201. Customers were also instructed to complete and return page 2 of the letter by fax to 215-256-9191. For questions regarding this recall call 215-256-4201.

Device

Device Recall 9.6F Plastic Dignity MidSized CT port w/PreAttached Silicone Catheter
  • 모델명 / 제조번호(시리얼번호)
    MRCTI96801 Lot# MHWQ060 S2 , UDI# 884908031232
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution to PR and Panama
  • 제품 설명
    9.6F Plastic Dignity Mid-Sized CT Port w/Pre-Attached Silicone Catheter || The CT Power Injectable Implantable Infusion Ports are indicated for patient therapies requiring repeated access to the vascular system. The port system can be used for infusion of medications, I.V. fluids, parenteral nutrition solutions, blood products, and for the withdrawal of blood samples. When used with a power injectable needle, the Power Injectable Implantable Infusion Port device is indicated for power injection of contrast media
  • Manufacturer
    Medical Components, Inc dba MedComp

Manufacturer

Medical Components, Inc dba MedComp
  • 제조사 주소
    Medical Components, Inc dba MedComp, 1499 Delp Dr, Harleysville PA 19438-2936
  • 제조사 모회사 (2017)
    Medical Components Inc.
  • Source
    USFDA