19/07/2024 -
Comunicamos que o fabricante dos produtos Arteriofix 20G 80mm, B. Braun Melsungem AG, identificou a possibilidade de unidades do produto apresentarem um pequeno vazamento de sangue, na...
18/07/2024 -
A Stryker Neurovascular observou uma frequência aumentada de danos no revestimento de PTFE que ocorrem nos fios-guia Synchro, que podem ser causados pela prática de backloading o...
17/07/2024 -
Foi verificado que a reparação de um molde em um fornecedor causou tensão na parte invisível do cursor que move a fibra a laser. Como resultado, podem desenvolver-se...
10/07/2024 -
Boston Scientific is initiating a removal of certain lots of Capio™ SLIM Suture Capturing Device (Capio™ SLIM) due to an increase in reports of the device not catching the suture needle/dart as...
10/07/2024 -
A empresa Cremer AS, grupo Viveo, entrou em contato com a VR Medical, informando a divergência dos rótulos em português, colocados no Brasil, do produto Sonda com Balão...
05/07/2024 -
Cardinal Health was recently informed of a medical device recall from Ethicon concerning various sutures (Vicryl™, Vicryl™ Plus, PDS™ II, PDS™ Plus, Monocryl™ and Monocryl™ Plus). The...
01/07/2024 -
Cardinal Health began distributing Monoject™ syringes branded as "Cardinal Health Monoject™ syringes" however, the new syringes have different dimensions than prior Covidien Monoject™ syringes....
14/06/2024 -
Ethicon identified a manufacturing issue on a specific packaging machine that resulted in a hole in the primary packaging of a small percentage of VICRYL™, PDS™, MONOCRYL™ and...
13/06/2024 -
Em virtude do laudo de análise 313.1P.0/2024, emitido pela Fundação Ezequiel Dias - FUNED, onde o produto apresentou resultado insatisfatório no ensaio de...
11/06/2024 -
Smiths Medical has identified the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect®, BLUgriggs® and BLUperc® products...
04/06/2024 -
Smiths Medical has identified that the securement flange of specific lots of the Bivona® neonatal/pediatric and adult tracheostomy products may tear because of a manufacturing defect.
Recall start...
03/06/2024 -
Specific item(s) and lot(s) of convenience kits containing syringes affected by the FDA safety communication issued on March 19, 2024 which identified potential issues with these products,...
03/06/2024 -
Southmedic has identified inclusion of lancet (swa02a) that has been labelled with an expiry date which precedes the overall kit's expiry date. The sterility of the lancet may be compromised before...
03/06/2024 -
Cook Medical identified that devices from the affected device lots may have packaging seals that do not meet peel strength specifications. This creates a potential of a sterile barrier failure...
30/05/2024 -
The decision to conduct a voluntary removal of the product was based on the following: through an internal investigation, it was identified that there is a defect in the external sterile packaging...
29/05/2024 -
Medtronic is notifying customers of a design update implemented to reduce the potential for tissue growth into the Ascenda™ catheter connector which may potentially lead to catheter...
20/05/2024 -
Foi identificado erro na tampografia do componente cateter lombar. Este item é pertencente ao kit do produto Conjunto de Cateter de Drenagem Externa Lombar, registro ANVISA n°.:...
16/05/2024 -
Foi identificado erro na tampografia do componente cateter lombar. Este item é pertencente ao kit do produto Conjunto de Cateter de Drenagem Externa Lombar, registro ANVISA n°.:...
16/05/2024 -
Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the...