Tecnología Médica
Mapa TecMedTecnología Médica
Non-sterile, Single-use Pneumatic Tourniquet Cuffs Conservation Strategies – Letter to Health Care Providers
06/06/2023 -
Read the recommendations for health care facilities and providers due to localized supply constraints of non-sterile, single-use pneumatic tourniquet cuffs.
Alerta 4153 (Tecnovigilância) - Comunicado da empresa Bard Brasil Indústria e Comércio de Produtos para Saúde Ltda - Magic 3 GO Cateter Urinário Intermitente Feminino (80689090170); Magic3 GO Cateter Urinário Intermitente Sure-Grip (80689090171).
29/05/2023 -
A planta de fabricação da “BD” (Becton Dickinson), que produz os Magic3 Go® Cateter Urinário Intermitente identificou uma não conformidade em que alguns...
Radspeed Pro X-Ray and CH-200 Ceiling Tube Supports
22/05/2023 -
The ceiling tube support for the above device consists of an x-ray tube support pull-up section and an x-ray tube support section to which an x-ray tube assembly is mounted, and the tube holding...
Alerta 4137 (Tecnovigilância) - Comunicado da empresa Auto Suture do Brasil LTDA - Cateter de Alto Fluxo para Hemodiálise Mahurkar QPLUS e Acessórios - Possibilidade de comunicação cruzada do circuito sanguíneo.
10/05/2023 -
Durante o processo de fabricação, uma possível condição de vazamento interno dentro do hub do Cateter para Hemodiálise de Alto Fluxo e Lúmen Duplo...
Alerta 4138 (Tecnovigilância) - Comunicado da empresa Smiths Medical do Brasil Produtos Hospitalares Ltda - Sistema de Administração CADD - Oclusão do tubo - problemas no fornecimento de medicamento.
10/05/2023 -
Dois possíveis problemas com o produto: Falta de fornecimento ou fornecimento insuficiente de medicamento, relacionado à Oclusão do Tubo e alarmes falsos "Nenhum...
Single Use Distal Cover
08/05/2023 -
Olympus has become aware that the single use distal cover MAJ-2315 may cause mucosal injury, become cracked and/or detach from the endoscope during use. Olympus redesigned the distal cover and has...
Medline Surgery Packs
05/05/2023 -
Medline Industries, Lp is recalling custom procedure packs containing Steris's sterile light handle cover lb53 & lb44 because they may separate from the light handle (detach and fall off) during...
Disposición N° 342/2023
20/04/2023 -
Prohíbese el uso, la comercialización y la distribución de los productos rotulados como: 1) MAGIC THREAD, Polydioxanone Absorbable Suture. Sterilized by E.O. Gas. Dermax Co.,...
Alerta 4095 (Tecnovigilância) - Comunicado da empresa Gabisa Medical International Ltda Epp - Coletor de Urina Sistema Fechado (Neonatal) GMI - Vazamento na conexão - Recolhimento. Devolução para o fabricante.
11/04/2023 -
Durante a sondagem vesical de demora, utilizado bolsa coletora neo/ped foi identificado vazamento na conexão em duas unidades utilizadas.
Perda do controle da diurese.
Alerta 4094 (Tecnovigilância) - Comunicado da empresa Laboratórios B. Braun S/A - Instrumental Bipolar de uso único Aesculap - Soltura de uma mola contida na mandíbula do produto - Recolhimento. Devolução para o fabricante.
11/04/2023 -
A empresa comunica que o fabricante do produto pinça Caiman Maryland, Aesculap AG, identificou a possibilidade de um desvio funcional na mandíbula da pinça, que pode ocasionar...
Intellanav Stablepoint Ablation Catheter
10/04/2023 -
During the execution of 2 year real time aging, an issue was identified during bubble testing where there was a leak in the sealed sterile barrier of the packaging. Further investigation...
Sterile Light Handle Cover
27/03/2023 -
Steris identified through customer complaints that the LB53 light handle covers may separate from the light handle (detach and fall off) during use. Through additional investigation Steris has...
Disposable Rotatable Clip Fixing Device
20/03/2023 -
Olympus has received complaints that the clip did not come out of the tube sheath during the procedure. investigation by Olympus confirmed the tube sheath is longer than specifications which prevents...
Surgical Gut - Plain and Absorbable Sutures
20/03/2023 -
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product.
Recall start date: March 1, 2023
Habib™ EndoHPB Catheter
17/03/2023 -
During investigational testing of the Habib™ Catheter with the ERBE VIO 3 generator (compatible 3rd party device), an issue with the generator setting in the Habib™ IFU...
Express Mini 500 and Pneumostat Chest Drain Valve
16/03/2023 -
The instructions for use (IFU) for the Pneumostat Chest Drain Valve and for the Express Mini 500 do not provide sufficient precaution against draining the device for continued use. Additionally, the...
Lo-Pro Tracheal Tube Cuffed Murphy Tip
27/02/2023 -
Starting in September 2022, customers reported tracheal tube inflation system leaks. Medtronic's investigation identified a manufacturing assembly error which resulted in an incomplete closure...
Tracoe Experc Sets
23/02/2023 -
It was discovered that the Instructions for Use (IFU) of the Tracoe Experc dilation set, ref 520, has not been included in the product scope of the Tracoe Experc sets for Vario, Twist and Twist...
BD Insulin Syringes With The BD Micro-Fine IV Needle
22/02/2023 -
The affected products were manufactured using unvalidated materials that can result in unsealed packaging for the individual syringes. Recall start date: February 3, 2023
