Events

Alerte De Sécurité sur Disposable Hypodermic Syringe 60ml- Laborjet Syringe 60ml, lot 2010-12-15 - registry nº 10369460015.

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Labor Import.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    1306
  • Date
    2013-10-14
  • Pays de l'événement
    Brazil
  • Source de l'événement
    ANVISA
  • URL de la source de l'événement
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    According to the manifestation of the company, in compliance with RDC 23/2012, the deviation verified was punctual; in the investigation it was found that a failure occurred in a cutting equipment of the packages and a blade detached from the equipment falling into the package. The company is identifying the units still available for pickup. If a customer still identifies any units in their inventory, please contact the company for arrangements regarding product pick-up.
  • Cause
    According to the report of analysis os 112.298852 / 2013 and proof of analysis of fiscal analysis of single sample, the product disposable hypodermic syringe 60 ml, date of manufacture 15/12/2010, val. 3 years, lot 15-12-2010 was considered unsatisfactory in the aspect assay.
  • Action
    The Sanitary Vigilance of the State of São Paulo determined the prohibition of commercialization and use, as well as the collection of the product, through publication in the State of São Paulo (DOE) of 08/21/2013 page 43, CVS Communiqué - 08-08-2013

Device

Disposable Hypodermic Syringe 60ml- Laborjet Syringe 60ml, lot 2010-12-15 - registry nº 10369460015.

Manufacturer

Labor Import
  • Source
    ANVSANVISA