The UK’s Medicines and Healthcare products Regulatory Agency issued a massive recall of NovaLine bloodlines used with Baxter/Gambro dialysis machines.
Manufactured by Vital Healthcare, the recall affects all lots of NovaLine tubing sets for hemodialysis that were manufactured in 2017. Specific product codes manufactured in 2017 have functional and assembly issues that may lead to air entering the system, blood loss, clotting and delays in treatment, the manufacturer said in the field safety notice.
The agency listed seven possible failures of the devices and actions customers should take to mitigate the risks. The manufacturer said all affected products should be removed from inventories.