Medical device manufacturer, Draeger, has issued a field safety notice concerning its reusable latex breathing bags with part numbers 2165686, 2165953, 2165694, 2165708, 2165716, 2165724, 2165763, 2165775 and 2165783,as part of test lung with part number 8403201, and as part of reusable anaesthesia sets with part numbers M33681, M27542, M34822, M34823 and M34824.
The manufacturer became aware of an incident where a user suffered an acute allergic reaction after using a Drager latex test lung. During investigation of this incident, the manufacturer discovered that the breathing bag that belongs to the test lung and other latex breathing bags are labelled NR, which is the abbreviation for natural rubber (latex). However, the labelling does not comply with the applicable international standards for medical devices.
Drager breathing bags made of latex (blue) are distinguishable from the latex-free version made of silicone (transparent) by their colour. The test lung with part number 8403201 and the breathing bags in the reusable anaesthesia sets with part numbers M33681 and M27542 have been switched to the latex-free version made of silicone.
The manufacturer reminds users that the blue reusable breathing bags bearing the marking "NR' do contain natural rubber (latex) and latex products can cause allergic reactions. Furthermore, the manufacturer is currently working on improved labelling on the products.
According to the local supplier, the affected products were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 11 March 2014