Medical device manufacturer, Greiner Bio-One, has issued a medical device safety alert concerning VACUETTE Safety Blood Collection Sets and Blood Collection Sets.
According to the manufacturer, the VACUETTE Safety Blood Collection Set and accessory may display leaking during use due to a crack on the luer connector piece. Due to claim from France and due to a supplier's notification after a supplier audit, Greiner Bio-One decided to recall some products from the market. The manufacturer estimates the risk for the user as being low. The root cause of the defect is attributed to the fact that the connectors of the defective lot have not been annealed. This non-annealing could brittle the connector and may lead to a crack in the connector.
According to the manufacturer, 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 2 April 2013