Events

PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON 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
    43918
  • 사례 위험등급
    II
  • 사례 시작날짜
    2014-05-07
  • 사례 국가
    Canada
  • 사례 출처
    HC
  • 비고 / 경고
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • 데이터 추가 비고
  • 원인
    Biosense webster has identified an increase in reports of partial tip separation for the pentaray nav and pentaray nav eco catheters. after conducting a root cause analysis biosense webster has identified an issue in the production process that can lead to an insufficient bond of the distal tip to the catheter shaft which could pose a safety risk to the patient.

Device

PENTARAY NAV ECO HIGH DENSITY MAPPING CATHETER
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: D128208 (Lot serial: NOT SOLD IN CANADA); Model Catalog: D128207 (Lot serial: NOT SOLD IN CANADA); Model Catalog: D128211 (Lot serial: NOT SOLD IN CANADA); Model Catalog: D128210 (Lot serial: NOT SOLD IN CANADA); Model Catalog: D128205 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: D128201 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: D128202 (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: D128204 (Lot serial: >10 NUMBERS CONTACT MFR)
  • 제품 설명
    PENTARAY NAV ECO CATHETER
  • Manufacturer
    JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.

Manufacturer

JOHNSON & JOHNSON MEDICAL PRODUCTS A DIV. OF JOHNSON & JOHNSON INC.