Events

SANDEL Weighted Safety Scalpels 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ansell Ltd T/A Ansell Healthcare 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-2015-RN-00167-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-02-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00167-1
  • 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
    In november of 2013 ansell limited undertook a recall of a number of specific batches of some of the product codes for the above product. tga recall rc-2013-rn-01152-1 refers. this recall was closed out by the tga on 13 february 2015.As an interim corrective action, both the overseas manufacturer and ansell limited in california implemented a 100% visual inspection of all product prior to shipping from our warehouse to prevent recurrence of the problem of the safety shield moving and the blade tip being exposed.Subsequently, one customer complaint has been received of a user receiving an injury from an exposed blade tip while picking up the scalpel from the dispenser pack. this was a scalpel not originating from any identified lot of product from the original recall.Upon inspecting warehouse stock, we have further identified a small number of scalpels where the blade tip has become exposed. these were all found before the product was shipped to distributors or customers.
  • 조치
    Ansell is requesting users to quarantine affected lots and return to Ansell for replacement or credit. This action has been closed-out on 1/06/2016.

Device

SANDEL Weighted Safety Scalpels
  • 모델명 / 제조번호(시리얼번호)
    SANDEL Weighted Safety ScalpelsCatalogue numbers: 2210-N, 2211-N, 2215-N, 2220-N, 2210-L, 2211-L & 2215-LARTG number: 196914
  • Manufacturer
    Ansell Ltd T/A Ansell Healthcare

Manufacturer

Ansell Ltd T/A Ansell Healthcare