Alerta De Seguridad para 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

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.

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.