Events

Alerte De Sécurité sur Volumet AGILIA VL ST, Model: VL ST01, VL ST02, Registration No. 10154450165 - lots: a) MODEL VL ST01: 71HF30DB00, 71HF30DB00, 71HF30D00, 71HF30DD00, 71HF30DD00, 71HH19DA00, 71HH19D0000, 71HH19D0000, 71HH19DD00, 71HI05DA00, 71HI05DB00, 71HI12DA00, 71HI09DA00, 71HI11DA00, 71HI15DA00, 71HI12DA00, 71HI16DA00, 71HI17DA00, 71HI18DA00, 71HI19DA00 -. b) TYPE VL ST02: 71HE31DF00, 71HE29DA00, 71HE31DF00, 71HE29DB00, 71HE30DA00, 71HE30DB00, 71HE30DC00, 71HE31DA00, 71HE31DB00, 71HE31DC00, 71HE31DD00, 71HG15DA00, 71HG15DC00, 71HG15DB00, 71HG15DB00, 71HG15DC00, 71HG17DA00, 71HG15DD00, 71HG17DB00, 71HG22DC00, 71HG22DD00, 71HG15DD00, 71HG17DA00, 71HG22DC00, 71HH19DI00, 71HH19DK00, 71HH21DB00, 71HH21DC00, 71HH26DC00.

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 Fresenius Hemocare Brasil Ltda..

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
    1447
  • Date
    2014-10-17
  • 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 company, the divergence in information does not risk the patient, considering that the product is in fact free of DEHP. The divergence of information is in the place of symbols. The DEHP free information is correctly described on the label. The company also informs that this product is of exclusive use for pump of infusion and restricted to the hospital scope. #### UPDATED ON 08/18/2017, the field action documentations submitted by the company are filed in the area. If necessary, the area can reassess the action at any time.
  • Cause
    The company informs that an error was identified in the labeling of the product. the product is exempt from dehp, and this information appears on the label, i do not understand in the area where the symbols of "barren, single-use product, keep out of moisture, among others" were misprinted, the symbol "contains dehp ". the difference in the contains and does not contain deph symbol is only a transverse trait.
  • Action
    The company forwarded communication to customers who have already received the product stating the error.

Device

Volumet AGILIA VL ST, Model: VL ST01, VL ST02, Registration No. 10154450165 - lots: a) MODEL VL S...

Manufacturer

Fresenius Hemocare Brasil Ltda.