1000mL Receptal System (waste disposable suction system) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Hospira Pty Limited 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-00413-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-05-10
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • 데이터 추가 비고
  • 원인
    Hospira have received customer reports where the 1000ml receptal system is not achieving vacuum and/or improper fit of the pvc liner.
  • 조치
    Hospira is advising their customers to quarantine all 1000mL Receptal System units and use an alternative Receptal Liner (1500 mL or 2000 mL). If alternative devices are not available Hospira has provided work around instructions to reduce the safety risk to patients due to any reduction or failure of vacuum.

Device

  • 모델명 / 제조번호(시리얼번호)
    1000mL Receptal System (waste disposable suction system)Canister 1000 mLInventory number: 434490411List number: 43449 PVC Liner 1000 mLInventory number: 0L2129701List number: L212A52
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA