Medtronic has issued a warning letter regarding some of its Perfusion Tubing Packs.
Friedly, Minnesota-based Medtronic’s urgent field safety notice informs users that some of its Perfusion Tubing Packs were manufactured without device-level testing for bacterial endotoxin, which is a necessary step to support non-pyrogenic label claim. The potential patient harms from endotoxin-mediated pyrogenicity include fever, infection, toxic reaction and death from complete organ failure.
Get the full story on our sister site, Medical Tubing + Extrusion.