Events

Alerta De Seguridad para Trade name: Zelos PTA Balloon Catheter ///. Technical name: Dilating balloons ///. ANVISA registration number: 80134860129 ///. Risk class: III - High Risk ///. Affected Model: 1740-1202, 1740-1204, 1740-1402, 1740-1404, 1740-1602, 1740-1604, 1740-1802, 1740-1804, 1740-2002, 1740-2004, 1740-2202, 1740-2204 , 1740-2402, 1740-2404, 1740-2602, 1740-2604, 1740-2802, 1740-2804. Affected lots: 6000120532; 6000125088; 6000114594; 6000135485; 6000132932; 6000125362; 6000118615; 6000134870; 6000126658; 6000120181; 6000134871; 6000122178; 6000135767; 6000133004; 6000125184; 6000118560; 6000133399; 6000131825; 6000122178; 6000114594; 6000126135; 6000116861; 6000114097; 6000126155; 6000120181; 6000122609; 6000124187; 6000117794; 6000108952; 6000114594; 6000126135; 6000116861; 6000131502; 6000120181; 6000122178; 6000124187; 6000108952; 6000117822; 6000108953; 6000118560; 6000126135; 6000132020; 6000131502; 6000128186; 60000126135; 60000121977; 60000126044; 60000108952; 6000086400 6000123357; 6000132020; 6000101035; 6000121977; 6000123182; 6000123182; 6000122750; 6000117794; 6000114097; 6000112476; 6000123732; 6000104902; 6000116861; 6000112476; 6000108952; 6000122608; 6000123357; 6000124187; 6000126155

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Grifols Brasil Ltda; Optimed Medizinische Instrumente GmbH.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    2016
  • Fecha
    2016-09-06
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    1. Please remove all affected products from your inventory, lock and store them in a separate area. These products should not enter into clinical use. 2. Please send this letter to all team members in your organization who need to be aware of this FSCA. 3. Please complete the response letter with the quantity of products to be returned and how many units of the withdrawn lots have already been used. 4. Please return the completed and signed response letter even if you are not returning any product by fax, email or mail to Optimed within 10 days. (Dear customer, please disregard this item, as this procedure will be done by Grifols with the information sent by you.) 5. If you have additional questions about returning the product, credit note, replacement or shipping, please enter please contact your Optimed sales representative or our customer service on + 49 7243 76 33 524. 6. Please return only the affected products listed in the reply letter to the address of Optimed headquarters. A credit note will be issued for all returned sterile products. 7. In case the company, as a distributor, has passed these products to third parties, please send a copy of this information to each of the parties and guarantee the return receipt of the information about the products used and the products to be returned to clients (for example, hospitals). This information must be completed in the response letter.
  • Causa
    Evaluation of further tests performed for routine monitoring of the sterilization process revealed that the sterility of the zelos pta balloon catheters can not be guaranteed prior to use. there was a risk that the use of non-sterile products could lead to inflammation or infection. as of the date of the information, optimed has not received any customer complaint or report of damage to the patient's health due to lack of sterility. the root cause could not yet be identified. until the root-cause analysis is completed, no statement can be made regarding the root cause for the non-sterility of the catheter balloon zelos pta.
  • Acción
    Field Action Code 2016-04 triggered under the responsibility of the company Grifols Brasil Ltda. Company is promoting the collection of units that have not yet exceeded the five-year

Device

Trade name: Zelos PTA Balloon Catheter ///. Technical name: Dilating balloons ///. ANVISA registr...

Manufacturer

Grifols Brasil Ltda; Optimed Medizinische Instrumente GmbH
  • Source
    ANVSANVISA