Events

Safety Alert for STERRAD HYDROGEN PEROXIDE CASSETTE, Model STERRAD 100S - Registration 80145900784 - Lots - See Annex 1 - Distribution List

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.

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
    1370
  • Date
    2014-03-10
  • 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
    The company informs that there is no impact on the health of the professional or the sterility of the processed devices. Still, it is very unlikely that this event will impact the use of the STERRAD® 100S sterilization system. ASP has already initiated corrective action to eliminate this defect in the manufactured product. • If the STERRAD® 100S sterilization system can not read the bar code, an error message may be displayed: "Can not accept cassette". • If the STERRAD® 100S sterilization system can read the bar code, the injection needles may align incorrectly or one of the following error messages may appear: "Injection Injection System (ISI)" or "Low Injection Pressure 1". In such situations, please read and follow the operating instructions for removing the STERRAD® 100S cassette. • If your STERRAD® 100S system experiences multiple cycle cancellations, it may be due to the damage of the injection needles, which may require a visit by the company's technical support.
  • Reason
    The company holding the record informs that advanced sterilization products - asp has determined that 76 batches of the sterrad® 100s cassette may contain misaligned bar code and can be rejected by the sterrad® 100s sterilization system.
  • Action
    The company requests that customers evaluate the STERRAD® 100S cassette inventory to determine if they are part of the affected batches list below: • If your entire inventory is part of the affected batches list, ASP recommends that the customer continue to use them until it receives lots unaffected, as the probability of damage to the injection needles is low and there is no risk to the health of the professional or the sterility of the processed devices. Once the unaffected batches have been received, the customer may discontinue use of the batches and return them for replacement purposes. • If you have affected and unaffected batches of batches, the batches used should be discontinued and batches sent to the company for replacement. For more information, see Annex 2 - Customer Letter

Device

STERRAD HYDROGEN PEROXIDE CASSETTE, Model STERRAD 100S - Registration 80145900784 - Lots - See An...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda