Events

Skater® (7565 and 7560 series) and TCD Choice Lock (7160 and 7165) Direct Drainage Drains 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 Angiotech-PBN MEDICALS Denmark A / S 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
  • 날짜
    2009-09-21
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/rappel-de-tous-les-lots-des-dispositifs-medicaux-sets-de-drainage-en-ponction-directe-skater-r-gammes-7565-et-7560-et-tcd-choice-lock-gammes-7160-et-7165-fabriques-par-pbn-medicals-denmark-a-s
  • 비고 / 경고
    French data is current through early September 2018. All of the data comes from L’Agence nationale de sécurité du médicament et des produits de santé (ANSM), 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 France.
  • 데이터 추가 비고
  • 조치
    On 16/09/2009, the company Angiotech-PBN MEDICALS Denmark A / S has withdrawn from the market all the batches of the references listed in the annex (21/09/2009) (44 ko) of the recall letter of the medical devices called: sets Skater® (7565 and 7560 series) and TCD Choice Lock (7160 and 7165) Direct Drainage Drains, manufactured by PBN MEDICALS Denmark A / S, as a result of claims received abroad for damaged secondary packaging. Indeed, the laboratory determined that the sterility integrity of the products distributed between September 2004 and September 2009 could be compromised. The loss of sterility presents an infectious risk. Angiotech-PBN MEDICALS Denmark A / S has directly notified the recipients of the offending batches with the attached message (21/09/2009) (91 KB) validated by Afssaps. This information is addressed to the directors and correspondents of materiovigilance for diffusion if necessary to the services concerned. The relevant European Competent Authorities have been informed of this measure by the manufacturer.

Device

Skater® (7565 and 7560 series) and TCD Choice Lock (7160 and 7165) Direct Drainage Drains

Manufacturer

Angiotech-PBN MEDICALS Denmark A / S
  • Source
    LAANSM