Medical device manufacturer, Biocompatibles UK Ltd, has initiated a field safety corrective action concerning limited batches of Bead Block Embolization Agent.
The affected batches can be identified by the following catalogue numbers [EB2S305, EB2S709, EB2S912] and lot numbers [S10348, S10355, S01345, S10347] respectively.
According to the manufacturer, 4 batches of the product will be recalled from the market due to endotoxin level was out of specifications. No patient safety reports have been received regarding the issue.
According to the local supplier, the affected products have been distributed in Hong Kong. If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted 23 May 2012