Events

Safil Sutures Safil Violet 1 (4) 70cm HR26 Safil Violet 4/0 (1,5) 70cm HR22 Safil Violet Undyed 4/0 (1,5) 70cm, DS24 Safil Violet Undyed 2/0 (3) 70cm HR26 Safil Violet 3/0 (2) 70cm, HR22 Safil Violet 2 (5) 70cm HR 37S Safil Violet 2 (5) 70cm HR37S 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 B Braun Australia 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-2018-RN-00737-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-06-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00737-1
  • 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
    B. braun has been identified that some of the items in specific batches have damaged packaging which may affect the sterility of the products. no specific monitoring of patients is recommended at this time.To date, there have been no reports of any adverse patient outcome which could be associated with this potential sterility issue.
  • 조치
    B. Braun is requesting customers: 1. Identify, quarantine and return affected devices; 2. Do not use affected devices anymore; 3. Patients with affected devices in use should be monitored carefully; 4. Inform the responsible personnel in the relevant facilities; and 5. Confirm receipt of the correspondence as per the instructions given in the Customer Letter.

Device

Safil Sutures Safil Violet 1 (4) 70cm HR26 Safil Violet 4/0 (1,5) 70cm HR22 Safil Violet Undyed 4...
  • 모델명 / 제조번호(시리얼번호)
    Safil Sutures Safil Violet 1 (4) 70cm HR26Safil Violet 4/0 (1,5) 70cm HR22Safil Violet Undyed 4/0 (1,5) 70cm, DS24Safil Violet Undyed 2/0 (3) 70cm HR26Safil Violet 3/0 (2) 70cm, HR22Safil Violet 2 (5) 70cm HR 37SSafil Violet 2 (5) 70cm HR37SMultiple Item Codes and Batch NumbersARTG Number: 222738
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd