Events

Safety Alert for 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

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Grifols Brasil Ltda; Optimed Medizinische Instrumente GmbH.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    2016
  • Date
    2016-09-06
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    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.
  • Extra notes in the 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.
  • Reason
    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.
  • Action
    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