Events

Safety Alert for Wyler AD-TECH Electrode Cable (Cable Connector for Electrode XX Contacts (04, 06, 08, 16, 32 and 64 contacts and Forame Oval 04 contacts) // ANVISA registration number: 10244510006. Technical Name: Cable Connector for Electrode // Hazard Class: IV - Maximum Hazard // Model Affected: L-DCL-4DINX; L-DCL-6DINX; L-DCL-8DINX; L-DCL-16BDINX; L-DCL-32BDINX; L -DLC-64BDINX and FO-LDC-4DINX // Serial numbers affected: 208140559, 208140560, 208140561, 208140562, 208140563 and 208140579

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Physiomed Importação e Comércio Eireli; AD TECH Medical Instruments Corporation.

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
    1916
  • Date
    2016-04-29
  • 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
    Customer Recommendations: AD-TECH believes that these products may be compromised by sterilization, so we urge you to immediately examine your inventory and segregate all products in closed / unused packaging that are the reason for this recall, and return to Physiomed at the following address: Physiomed Importação e Comércio Ltda. If you have knowledge of any patient case that has used the product of the affected lot and has presented adverse reactions, we request that inform us what happened, through the means of contact shown below: Phone for contact: (11) 5593-2240 E-mail: sac@physiomed.com.br / talitha.fernandes@physiomed.com.br. According to the company, to date, technical complaints, occurrences of health damages, adverse reactions or any other complaints related to these products, both in Brazil and internationally, have not been reported to the manufacturer or the holder of the registration in Brazil (Physiomed) . This payment by the manufacturer is a precautionary measure. Customers who received the notified products must check stock and return unused / unopened packaging to Physiomed for later return to the manufacturer.
  • Reason
    During a transport simulation at ad-tech medical instrument corporation, the company concluded that the packaging proved to be fragile during this simulation, which may compromise the sterile barrier of the product.
  • Action
    The manufacturer ADTECH MEDICAL INSTRUMENT CORP. initiated the recall due to the identification of defects in the packaging of these products (which constitutes compromise of the sterile barrier). This was identified during a transport simulation at the Ad-Tech Medical Instrument Corporation because the current packaging of this product is made up of grade-surgical type paper and proved to be brittle during this simulation. Field Action Classification: Return to Manufacturer Return. Field Action Code: 001/2016.

Device

Wyler AD-TECH Electrode Cable (Cable Connector for Electrode XX Contacts (04, 06, 08, 16, 32 and ...

Manufacturer

Physiomed Importação e Comércio Eireli; AD TECH Medical Instruments Corporation
  • Source
    ANVSANVISA