Tecnología Médica
Mapa TecMedTecnología Médica
Nim Trivantage Emg Endotracheal Tube
29/11/2023 -
Medtronic has received 87 complaints as of October 5th, 2023 indicating potential health hazards of degraded or loss of functionality of the device with specific lots. The potential hazards can...
Maquet Cardiopulmonary Gmbh Perfusion Sets
29/11/2023 -
Maquet Cardiopulmonary Gmbh received customer complaints for custom tubing packs (CTP) reporting the perforation of the Tyvek, the upper part of the sterile barrier of the packaging. Upon further...
Cranial Access Kit
28/11/2023 -
Through an internal investigation, it was identified that there is a defect in the outer packaging of the cranial access kits. This defect can cause the packaging to split without any additional...
Do Not Use Cardinal Health Monoject Syringes with Syringe Pumps and PCA Pumps
22/11/2023 -
Cardinal Health Monoject syringes have demonstrated recognition and compatibility issues with certain infusion pumps.
Fresenius Medical Care Recalls Sanxin Single Use Syringes for Leakages
16/11/2023 -
Sanxin Single Use Syringes are used for hemodialysis treatments. They are recalled for blood or heparin solution leaking from the syringe.
Cardinal Health Recalls Monoject Disposable Syringes for Incompatibilities with Syringe Pumps
15/11/2023 -
Some Cardinal Health Monoject Luer-lock tip syringes have demonstrated recognition and compatibility issues with certain syringe infusion pumps.
Alerta 4309 (Tecnovigilância) - Comunicado da empresa Getinge do Brasil Equipamentos Médicos LTDA - Drenagem Torácica com Sucção Seca Oasis (80259110192); Drenagem Torácica com Selo Seco Express (80259110193).
15/11/2023 -
As instruções de uso (IFU) para os drenos torácicos Atrium Ocean, Oasis e Express não fornecem instruções de precaução suficientes para a...
Disposición N° 9363/2023
14/11/2023 -
Quedan sometidas a la presente disposición las actividades de elaboración, fraccionamiento/envasado, acondicionamiento, importación y depósito de productos...
Alerta 4304 (Tecnovigilância) - Comunicado da empresa Auto Suture do Brasil LTDA - Sistema de Orientação de Tratamento StealthStation S8.
13/11/2023 -
A Medtronic identificou uma anomalia do software que afeta determinados sistemas do StealthStation™ S8 e StealthStation FlexENT™. Em determinadas situações, essa anomalia...
Braun Spike Adapter and Universal Fill Kit
07/11/2023 -
Sub-assembly product code m43417505 was found to have the potential to leak due to poor concentricity and deformation in the male luer lock.
Recall start date: September 5, 2023
Disposición N° 7500/2023
06/10/2023 -
Prohíbese el uso, comercialización y distribución en todo el territorio nacional de todos los lotes y medidas del producto identificado como “Agujas hipodérmicas...
Monoject Syringe Luer-Lock Tip
02/10/2023 -
Specific lots of Cardinal Health Monoject™ luer-lock tip syringes (6 and 35 ml) have demonstrated recognition and compatibility issues with certain syringe infusion pumps. As a result, Cardinal...
Alerta 4265 (Tecnovigilância) - Comunicado da empresa Becton Dickinson Indústrias Cirúrgicas Ltda - BD Plastipak Seringa Hipodérmica sem Agulha.
25/09/2023 -
A BD confirmou que a embalagem das seringas BD Plastipak™ 10mL podem apresentar falha de selagem e/ou orifícios. A falha de selagem pode estar presente em qualquer ponto ao longo do...
Stryker Bipolar Forceps and Generator
12/09/2023 -
An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf...
Alerta 4253 (Tecnovigilância) - Comunicado da empresa Auto Suture do Brasil Ltda - Cateter de Duplo Lúmen para Hemodiálise Tal Palindrome e Acessórios.
06/09/2023 -
A análise pós-venda constatou a identificação incorreta de alguns kits de cateter contidos em 4 (quatro) lotes específicos dos Kits de Cateter Crônico...
Bivona Pediatric Tracheostomy Tube
01/09/2023 -
Smiths Medical has identified that the manufacturing date was incorrectly included as the expiration date on the unit box. The actual individual packaging has the correct expiration date which is...
Alerta 4246 (Tecnovigilância) - Comunicado da empresa Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda - Cateter de Mapeamento Carto Octaray.
29/08/2023 -
Entre setembro e outubro de 2022, a Johnson & Johnson recebeu duas (2) reclamações informando que os cateteres de Mapeamento Octaray™ apresentaram sinais de...
Alerta 4243 (Tecnovigilância) - Comunicado da empresa Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda - Sutura Cirúrgica Absorvível Sintética de PDS II.
28/08/2023 -
A Ethicon recebeu sete reclamações para um lote de suturas PDS II (polidioxanona) incolores em relação à baixa resistência à tração....
Medline Sterile Scissors
28/08/2023 -
Medline recalls sterile 4.5" iris scissors (dynj04049); tip protector may detach, risking unseen punctures in the sterile barrier. Recall start date: August 11, 2023
Medfusion Syringe Infusion Pumps
28/08/2023 -
The calibration of the force sensor used to detect occlusions may shift over time. If the force sensor calibration shift is large enough, the pump will display a system failure alarm (including force...
