Events

BSN Propax - Surgical procedure kits 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 BSN Medical 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
    21061
  • 사례 시작날짜
    2017-01-31
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: BSN Medical Ltd, 621 Rosebank Rd, Avondale, AUCKLAND
  • 원인
    Sterile consumable devices are being delivered with foreign particles found in a number of packets from two batches, appearing to be dust, lint , cardboard. another packet was found today with at least three foreign bodies in that it appear and feel (through the packing only ) to be metal shards/ shavings. two different batches are involved. this problem has the potential to cause injury or infection in patient. if the consumables are used in the manner they are meant to be, in the treatment of wounds following surgery. manufacturer advised medsafe would be informed today (26 jan 2017), 03februiary 2017 source of the metal fragment is the raw material, i.E. the maternity pad. company has then drawn the correlation that this raw material is used in some of bsn's sterilised customised procedure packs (cpps) and therefore are extending the product alert to include the cpps in its scope.
  • 조치
    Manufacturer to issue advice regarding use

Device

BSN Propax - Surgical procedure kits
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: 036, 056, 076 106, 116, 017, 046, 086, 096
  • Manufacturer
    BSN Medical Ltd

Manufacturer

BSN Medical Ltd