Sorbsan Calcium Alignate Dressings (Flat, Ribbon, Packing, Plus and Border) and Sorbsan Silver Calcium Alignate Dressing (Flat) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bosco Medical Australia 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-2016-RN-00727-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-01
  • 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
    Bosco medical australia has become aware of an issue related to the application of an incorrect expiry date to a number of sorbsan dressings. product has been labelled incorrectly with a 5 year expiry date instead of a 3 year expiry date. product effectiveness may be impacted if used past a three year shelf life, and may result in the need to change the dressing more often.
  • 조치
    Bosco Medical is advising customers to inspect stock and quarantine any remaining units of affected stock, for return to Bosco.

Device

  • 모델명 / 제조번호(시리얼번호)
    Sorbsan Calcium Alignate Dressings (Flat, Ribbon, Packing, Plus and Border) and Sorbsan Silver Calcium Alignate Dressing (Flat)Product Codes: 1400, 1410, 1411, 1412, 1415, 1420SA, 1421, 1421C, 1423, 1423C, 1425Multiple Lot Numbers affectedARTG Number: 168684
  • Manufacturer

Manufacturer