Tecnología Médica

Tecnología Médica

Alerta 3951 (Tecnovigilância)
21/09/2022 - Comunicado da empresa Getinge do Brasil Equipamentos Médicos Ltda - Cateter Balão Intra-Aórtico – Recolhimento – Devolução ao fabricante.
Update: Recommendations for Certain Medtronic Electromyogram Endotracheal Tubes and Risk of Airway Obstruction – Letter to Health Care Providers
19/09/2022 - Medtronic initiates recall for silicone-based EMG endotracheal tubes due to the risk of airway obstruction and ventilation failure.
Alerta 3950 (Tecnovigilância)
19/09/2022 - Comunicado da empresa Stryker do Brasil LTDA - Cateter Guia Guider Softip. Recolhimento. Devolução para o fabricante.
Baxter Healthcare Corporation Recalls Clearlink Basic Solution Set with Duovent for Risk of Leaks That May Expose Providers and Patients to Hazardous / Toxic Substances
16/09/2022 - The Clearlink Basic Solution Set with Duovent may begin to leak, which poses risk of serious injury or death.
Ent-Single-Use Suction Tube
15/09/2022 - The rounded tip can detach from the shaft which could be left behind in the the treated area or aspirated. Recall start date: September 7, 2022
Fep Introcan Safety IV Catheter - Straight (No Wings)
09/09/2022 - Investigation conducted at the manufacturing site identified deviations at the catheter hub that could lead to leakage of the product. Recall start date: August 25, 2022
Update: FDA No Longer Authorizes Use of Non-NIOSH-Approved or Decontaminated Disposable Respirators – Letter to Health Care Personnel and Facilities
29/08/2022 - The FDA revoked the emergency use authorizations for non-NIOSH-approved disposable respirators and the EUAs for decontamination and bioburden reduction...
Microclave Clear Sets
12/08/2022 - ICU Medical has identified the potential for a manufacturing defect within specific lots of Microclave clear sets, which may result in a visible gap between the Microclave clear connectors top and...
Disposición N° 5317/2022
10/08/2022 - Prohíbese el uso, la comercialización y la distribución en todo el territorio nacional del producto identificado como:”ACCU CHEK GUIDE por 50 tiras reactivas, LOT...
Alerta 3916 (Tecnovigilância)
03/08/2022 - Comunicado da empresa Emergo Brazil Import Importação e Distribuição de Produtos Médicos Hospitalares Ltda - Produto para Cateterização Venosa Central com Lúmen Múltiplo de Grande Calibre....
Covidien, LLC (Medtronic) Recalls Palindrome and Mahurkar Hemodialysis Catheters Due to Catheter Hub Defect
29/07/2022 - Covidien, LLC (Medtronic) is recalling Palindrome and Mahurkar hemodialysis catheters due to catheter hub defect.
Smiths Medical Recalls Certain Medfusion 3500 and 4000 Syringe Infusion Pumps for Software Issues That May Impact Infusion Delivery
25/07/2022 - Software issues affecting certain Medfusion Syringe Infusion Pumps could impact infusion delivery to patients.
Alerta 3906 (Tecnovigilância)
13/07/2022 - Comunicado da empresa Abbott Diagnósticos Rápidos S.A. - Perfil Lipídico/Glicose - Cholestech - Possíveis resultados incorretos para os pacientes. Atualização, correção ou complementação...
Alerta 3910 (Tecnovigilância)
13/07/2022 - Comunicado da empresa Auto Suture do Brasil Ltda - Echelon Reinforced - Micro Cateter foram expostos a uma substância úmida durante o transporte. Risco de contaminação do produto. Recolhimento....
Alerta 3897 (Tecnovigilância)
04/07/2022 - Comunicado da empresa Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda. - Cateter Soundstar Eco – Problema da imagem distorcida durante a visualização. Recolhimento.
Alerta 3894 (Tecnovigilância)
04/07/2022 - Comunicado da empresa Auto Suture do Brasil Ltda - Cateter de Duplo Lúmen para Hemodiálise Mahurkar Maxid e Acessórios - Vazamento dentro do hub do cateter. Recolhimento.
Intraosseous Powered Drive and Needle Kits
01/07/2022 - 1. Difficulty separating stylet from needle, which could result in inadvertent removal of the entire needle assembly or inability to remove the stylet from an indwelling intraosseous needle, both...
BD Announces Voluntary Recall on Intraosseous Products
23/06/2022 - BD (Becton, Dickinson and Company), a leading global medical technology company, announced a voluntary recall on the BD Intraosseous Needle Set Kits, BD Intraosseous Manual Driver Kits and BDTM...
Alerta 3880 (Tecnovigilância)
14/06/2022 - Comunicado da empresa E. Tamussino & Cia Ltda. - Cateter para Monitoração da Pressão Arterial – Excesso de material de revestimento na agulha - Recolhimento.
Alerta 3872 (Tecnovigilância)
07/06/2022 - Comunicado da empresa Dental Morelli Ltda - Elástico Látex - etiqueta de identificação do produto incorreta. Recolhimento. Destruição.
Atrium Medical Corporation Recalls iCast Covered Stent for Potential Balloon or Catheter Hub Separation That May Cause Patient Harm
06/06/2022 - The iCast catheter-placed stent supports the walls of structure within the body. The balloon or catheter hub may separate during removal, causing harm to the patient.