Events

Safety Alert for Autoloid Filter Barrier Bacteria Virus Mechanical Ventilation PALL (Family BB) - REGISTRATION 10234400072 - Validity 04/04/2015. REFERENCE: BB100MFSLA. LOTS: 116406 - 118804 - 131904. THE COMPANY INFORMED THAT IT COULD EXPAND THE FIELD ACTION.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Pall Biomedical Products Company.

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
    1157
  • Date
    2012-07-27
  • 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
    Field action motivated by notifications made by NOTIVISA to the National Health Surveillance System - SNVS and customer complaints made to the company. #### Update 13/08/2012: The company increased the collection for product lots produced from 2007 to present. For additional information, consult the update of the alert message published by the company at http://portal.anvisa.gov.br/wps/wcm/connect/3c1079804c5eb4d6be1ffedc39d59d3e/Mensagem_de_Alerta_Atualizacao.pdf?MOD=AJPERES. . #### Update 18/12/2012: The company completed the field action in December 2012, with a total of 5,989 units destined for destruction.
  • Reason
    Incorrect positioning of the orange cap inside the product's corrugated tube. incorrect positioning / placement occurred during the assembly / fabrication process of the product. said lid may come loose inside the carton or attached to the outside of the corrugated tube. failure to observe the problem prior to its use may lead to obstruction of the oxygen passage.
  • Action
    - The company has blocked the lots in its inventory and is in the process of collecting the affected lots; - The company is arranging with ANVISA a change in the Instructions for Use of the product, in order to alert users to the importance of observing, before installation, if the corrugated pipe is unobstructed; - Until the changes in the Instructions for Use are approved by ANVISA, the company is attaching an addendum to the products informing of the need to adopt such precaution; - The company is issuing a Notice to all its customers (regardless of having received the batches affected by the warning recall) regarding the correct use of the product and the use of the orange cap; - Customers of the affected lots are being contacted in order to block the use of the product and the company picks it up; - The collection is being done by sales representatives and technical consultants of the company, who are also communicating the collection action with the customers.

Device

Autoloid Filter Barrier Bacteria Virus Mechanical Ventilation PALL (Family BB) - REGISTRATION 102...

Manufacturer

Pall Biomedical Products Company
  • Source
    ANVSANVISA