CENTRO DI DOCUMENTAZIONE SUI DISPOSITIVI MEDICI

FDA posts consumer information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death. Use the yearly lists to find information about Class I medical device recalls and some Class II and III recalls of interest to consumers. The links give details about what to do if you own or use one of these products. If you wish to find a Class II or Class III recall, you can search the  CDRH Recalls Database .   Please note that FDA now lists medical device recall notices by the date that it posts the recall rather than the recall initiation date. You can find the date that a firm initiated a recall in the text of the recall notice. Learn more about   medical device recalls here . Click here for> 2015 medical devices recalls

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Luca Martinelli Medical disposable gloves: structural materials different from latex Publication nr. 34 – 18th December 2013 1. FOREWORD In the last few years we have observed a sudden rise of irritant allergic and not allergic reactions, due to the use of latex gloves. Those are caused by the proteins that constitute latex and by chemical additives. Generalizing, latex allergies can be listed as follows: contact dermatitis eczema, allergic urticaria, generalized urticaria, angioneurotic edema, edema of the glottis, anaphylactic shock. To latex another cause of allergy is added: the powder used as lubricant. It was in fact demonstrated that the powder added into the gloves to fit them easily, can cause conjunctivitis, rhinitis and bronchial asthma because it work as an aeroallergen: means of transport of causative agent to respiratory tract. Deproteinization, dust delete and all the other solutions adopted have considerably helped to decrease the pe...

Updated to / Aggiornamento al  31.07.2015 LINK> REPORT RAPEX RAPEX is established as the EU rapid alert system that facilitates the rapid exchange of information between Member States and the Commission on measures taken to prevent or restrict the marketing or use of products posing a serious risk to the health and safety of consumers with the exception of food, pharmaceutical and medical devices, which are covered by other mechanisms. As of 2010, the system also facilitates the rapid exchange of information on products subject to EU harmonisation regulation and posing a serious risk to the health and safety of professional users as well as on those posing a serious risk to other public interests protected via the relevant EU legislation (e.g. environment and security). Both measures ordered by national authorities and measures taken 'voluntarily' by producers and distributors are reported by RAPEX. Every Friday, the Commission publishes a weekly overview of the...