Events

CONTACT DETACH INFUSION SETS 의 리콜

Health Canada (via FOI)에 따르면, 해당 리콜 는 Canada 에서 LIFESCAN CANADA A DIVISION 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
    90242
  • 사례 위험등급
    II
  • 사례 시작날짜
    2014-11-24
  • 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
    Manufacturer has identified an increase in reports of the tubing becoming detached at the connect/disconnect location. if tubing detachment occurs insulin delivery is interrupted and the pump will not alarm to notify patients. the interruption of insulin delivery can cause hyperglycemia which if left untreated can result in diabetic ketoacidosis (dka). dka is a serious condition that can cause a severe impact to health including death. symptoms of dka may include nausea vomiting shortness of breath and excess thirst/urination. manufacturer is advising patients to seek medical attention immediately if they are experiencing any of these symptoms.

Device

CONTACT DETACH INFUSION SETS
  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: 10090503 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10000601 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10000602 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10000603 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10000600 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10090502 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10090501 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10090500 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10024005 (Lot serial: 5052070); Model Catalog: 10024004 (Lot serial: 5052070); Model Catalog: 10024003 (Lot serial: 5052070); Model Catalog: 10024001 (Lot serial: 5052070); Model Catalog: 89-060-2522 (Lot serial: 5052070); Model Catalog: 10024005 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10024004 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10024003 (Lot serial: > 10 numbers contact mfg); Model Catalog: 10024001 (Lot serial: > 10 numbers contact mfg); Model Catalog: 89
  • 제품 설명
    Contact Detach Infusion Sets
  • Manufacturer
    LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON INC.

Manufacturer

LIFESCAN CANADA A DIVISION OF JOHNSON & JOHNSON INC.