CAPD Solution Transfer Set with Locking Connector, Minicap Extended Life PD Transfer Set with Twist Clamp, Minicap Extended Life PD Transfer Set with Twist Clamp (Extra Short and Extra Long) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Baxter Healthcare Pty Ltd 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
    RC-2013-RN-00536-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-06-06
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    Baxter is providing additional information regarding correct device use and additional warnings to end users. the improper use of peritoneal dialysis (pd) transfer sets could result in contamination leading to infection or peritonitis. there is also the potential of thyroid dysfunction following iodine exposure in children and infants. the current ifu does not list this as a warning.
  • 조치
    Baxter is providing additional information regarding correct device use and additional warnings to end users. This action has been closed-out on 01/02/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    CAPD Solution Transfer Set with Locking Connector, Minicap Extended Life PD Transfer Set with Twist Clamp, Minicap Extended Life PD Transfer Set with Twist Clamp (Extra Short and Extra Long)CAPD Solution Transfer Set with Locking ConnectorProduct code: 5C4160Minicap Extended Life PD Transfer Set with Twist ClampProduct code: 5C4482, R5C4482Extra Short product code: 5C4483, R5C4483Extra Long product code: R5C4484ARTG Number: 167416
  • Manufacturer

Manufacturer