Events

Safety Alert for Mobicath Bi-directional Guide Sheath Technical Name: Vascular Catheter Introduction Kit, Airship ANVISA Registration Number: 80145901385 Hazard Class: IV Affected Model: Mobicath - Short Curve and Long Curve Series Affected Numbers: SKU D140010, lots: W3332609 , W3338632, W3338635, W3348351, W3348350, W3338707, W3352503, W3359665, W3363850, W3370052, W3374700, W3374699, W3363851, W3379647, W3379650, W3384700, W3384701, W3390551, W3390549, W3397950, W3407815, W3397877, W3397879, W3407814, W3436355, W3436356 , W3436351, W3436358, W3441735, W3446769, W3441737, W3446767, W3449392, W3451862, W3451863, W3455439, W3455438, W3459354, W3455440, W3462467, W3462470, W3470335, W3470336, W3483637, X3489776, W3493240, W3497507, W3501348, X3497121, X3497510, W3501349 , X3501345, X3514814, X3501344, X3503248, X3507599, X3518116, X3565743, W3581648, X3581652, X3586059, X3592497. SKU D140011, lots: W3330988, W3330990, W3330688, W3338636, W3335354, W33351874, W3361889, W3363852, W3374701, W3379653, W3384702, W3392891, W3436359, W3441739, W3449393, W3451865, W3462471, W3470337, W3479706, X3493675, W3494912, X3497511, X3501245 , W3497509, X3501353, X3501350, W3501354, W3507597, X3507598, X3514815, W3542347, X3537038, X3565745.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Greatbatch Medical.

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
    2236
  • Date
    2017-03-20
  • 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
    - Examine the inventory and identify the batches affected that the customer has. - Isolate these devices immediately. - Complete the Confirmation Form indicating the number of devices to be returned and send the Form by email to J & J; Brazil.
  • Reason
    Greatbatch medical, the legal manufacturer of the mobicath® bi-directional guiding sheaths (bibicath® bi-directional guiding sheaths), is conducting a global voluntary field removal because of the discovery of a purse sealing integrity problem in specific batches of the guide sheath mobicath® bi-directional and, as a result, may compromise the sterile bag barrier.
  • Action
    Field Action Code 17000016 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will update, correct or supplement the instructions for use.

Device

Mobicath Bi-directional Guide Sheath Technical Name: Vascular Catheter Introduction Kit, Airship ...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Greatbatch Medical
  • Source
    ANVSANVISA