Alerta De Seguridad para Vented Paclitaxel Set

Safety alert

2015-11-05

2015-11-05

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20151105.html

Medical device safety alert: baxter healthcare vented paclitaxel set medical device manufacturer, baxter healthcare has issued a medical device safety alert concerning vented paclitaxel set. the affected product code and lot numbers are as follows: product code (lot number): mmc9627s (14h13v434) product code (lot number): vmc9627 (14i05t696, 14k19t380, 15b17t404) the manufacturer is voluntarily issuing a recall for the above referenced lots due to complaints for leaks at the spike’s air vent subassembly. according to the manufacturer, a leak in a paclitaxel set may result in a breach in sterility of the fluid path with subsequent contamination of the solution. if the leak was not detected during priming or initial set up, it would lead to serious adverse health consequences. besides, the leak may result in skin contact that would lead to potential irritation of skin. the manufacturer is advising users to inspect and quarantine any affected stock for return to the manufacturer. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the products, please contact your supplier for necessary actions. posted on 5 november 2015.