Alerta De Seguridad para Level 1® D/DI-60HL Normothermic IV Fluid Administration Sets, and HOTLINE® Blood and IV Fluid Warming Sets

Safety alert

2011-12-23

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20111223.html

Field safety notice: smiths medical voluntary recall for level 1® d/di-60hl normothermic iv fluid administration sets, and hotline® blood and iv fluid warming sets medical device manufacturer, smiths medical asd, inc., is conducting a product recall for the following products: a) level 1® d/di-60hl normothermic iv fluid administration sets, and b) hotline ® blood and iv fluid warming sets (product codes: l-70, l-70ni, l-80, l-270, and l-370). there was an increasing trend in reports of disconnections of the luer lock connector at the patient end of the tubing on certain sets of the above two products. based on the information provided by the manufacturer, if the luer lock connector disconnects during use, this could result in fluid/ blood loss and/ or a delay in therapy, which could result in patient injury, or while highly unlikely, death. the manufacturer has received no reports of serious injury or death related to the problem. according to the local supplier, the affected products have been distributed in hong kong. for details, please refer to the attached field safety notice (a) and field safety notice (b). if you are in possession of the affected products, please contact your supplier for further information and necessary actions.