Events

0.9% Sodium Chloride for Irrigation 2000ml and Water for Irrigation 2000ml 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-2014-RN-01091-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-10-10
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01091-1
  • 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
    Investigation of a small number of customer complaints has confirmed a reported problem of solution leaking into the overpouch. it has been identified that the issue was caused by a component used in the manufacture of the lots above, and is confined to these batches. there are no other affected products. this issue potentially impacts the sterility of the irrigation fluid.
  • 조치
    Customers are advised to locate and remove all of the affected products and lot numbers from their facility. The affected product should be returned for credit by contacting Baxter Healthcare Customer Service. Also, customers are advised to bring this matter to the attention of relevant prescribers within their hospital so that any patient who is undergoing infusion, or has very recently received an infusion of this product, can be monitored. This action has been closed-out on 22/08/2016.

Device

0.9% Sodium Chloride for Irrigation 2000ml and Water for Irrigation 2000ml
  • 모델명 / 제조번호(시리얼번호)
    0.9% Sodium Chloride for Irrigation 2000ml and Water for Irrigation 2000ml0.9% Sodium Chloride for Irrigation 2000mlProduct Code: AHB7616Batch Numbers: S77N6 & S77R8 (Expiry Date: July 2016) and S78F1 (Expiry Date: Aug 2016)Water for Irrigation 2000mlProduct Code: AHB7606Batch Numbers: S77N5 (Expiry Date: July 2016) and S78A6 (Expiry Date: Aug 2016)ARTG Number: 155928
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd