Herculite Ultra Herculite Ultra Unidose Refill C4 Enamel, Herculite Ultra Unidose Refill A2 Enamel, Herculite Ultra Unidose Refill A3.5 Enamel, Herculite Ultra Refill Syringe A2 Enamel 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Kerr 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-2014-RN-00909-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2014-08-18
  • 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
    Kerr corporation have received complaints that some herculite ultra products may be difficult to extrude or may not perform as intended. as a result, any composite extruded could exhibit signs of dryness and may not exhibit proper handling characteristics.
  • 조치
    End users are advised that if they have any of the affected product in their inventory to immediately return it to Kerr Australia. This action has been closed-out on 01/03/2016.

Device

  • 모델명 / 제조번호(시리얼번호)
    Herculite UltraProduct description/part number/lot number:Herculite Ultra Unidose Refill C4 Enamel351664650240,4718337, 4665811Herculite Ultra Unidose Refill A2 Enamel343484662093, 4678965, 4662092, 4667889, 4664839, 4681753, 4678966Herculite Ultra Unidose Refill A3.5 Enamel344484863611, 4861157, 4857439, 4786373, 4791140, 4791138, 4779744, 4734549 (Syringe)Herculite Ultra Refill Syringe A2 Enamel343384711654, 4672953, 4672288, 4734007, 4720200ARTG : 99818
  • Manufacturer

Manufacturer