Events

unkown device 의 리콜

L’Agence nationale de sécurité du médicament et des produits de santé (ANSM)에 따르면, 해당 리콜 는 France 에서 N/A 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
    2003-07-21
  • 사례 국가
    France
  • 사례 출처
    ANSM
  • 사례 출처 URL
    https://ansm.sante.fr/S-informer/Informations-de-securite-Retraits-de-lots-et-de-produits/retrait-de-lots-de-sets-de-soins-du-laboratoire-pharmaset
  • 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
    Following the withdrawal of batches 438396B (expiry date 11/2006), 439362B (expiry date 12/2006) and 443510B (expiry date 09/2007) of ampoules of 20 ml sodium chloride 0.9% AGUETTANT on June 27, 2003 (due to the evidence of foreign particles in some ampoules), the PHARMASET SAS Laboratory withdraws from the market care sets containing these batches of ampoules .. The ampoules of sodium chloride contained in these sets are used to rinse or purge devices (catheters, pipes ...). Each recipient will be informed directly of the references and sets of sets (containing the lots of ampoules that have been withdrawn) that were sent to him. Approximately 30 lots of sets are involved at 74 customers.

Device

unkown device
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    medical_device
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    LAANSM