Events

Alerte De Sécurité sur BIOVUE Peripherally Inserted Central Catheters (PICC) and Central Line Catheters: (1) No Latex, (2) Com-Latex; Catheterization Kits with Procedure Tray, PROTECTIV Safe Introduction System, and Family of Polyurethane Catheters OCRILON II BIOVUE (3) 16 G 5 Fr Dual Lumen PICC, (4) 18 G 4 Fr Double Lumen Central Line, (5) 18 G 4 Fr Lumen Double PICC, (6) 18 G 4 Fr Lumen Single Central Line, (7) 18 G 4 Fr Single Lumen PICC, (8) 20 G 3 Fr Single Lumen Central Line, (9) 20 G 3 Fr Lumen Single PICC, (10) 24 G 2 Fr Single Lumen PICC. Product number: (1) 97993, (2) 97994, (3) 97901, (4) 97919, (5) 97907, (6) 97922, (7) 97910, (8) 97925, (9) 97913, 10) 97916; all numbered lots are still in the validity period.

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 Ethicon Endo-Surgery Inc.

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
    548
  • Date
    2002-03-01
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Cause
    The sterility of the above procedure tray may be compromised; according to obvious damage to the integrity of the package (example: the package is crooked, crumpled). the manufacturer voluntarily initiated a removal by letter dated november 6, 2001.
  • Action
    Make sure you received the letter dated November 6, 2001 from Ethicon. Identify and isolate any affected product in your inventory. For more information, contact your local Ethicon representative. For further information, please contact ANVISA's Tecnovigilância Unit, by e-mail tecnovigilancia@anvisa.gov.br or by telephone (61) 448-1485

Device

BIOVUE Peripherally Inserted Central Catheters (PICC) and Central Line Catheters: (1) No Latex, (...

Manufacturer

Ethicon Endo-Surgery Inc
  • Source
    ANVSANVISA