Medline Industries recalled Centurion Medical’s primary warmer pack because it contains Vyaire Medical‘s recalled enFlow disposable cartridge that potentially exposes patients to unsafe aluminum levels.
Nearly three million enFlow disposable cartridges were recalled in March. The product is designed to warm blood, blood products and intravenous solutions before IV administration, but the potential for aluminum to elute from the warmer into the fluids led to the recall.
An FDA release said continued use of Centurion Medical’s product, another aid in IV administration, could lead to neurocognitive complications, bone marrow complications or death. Medline received four complaints, but no serious injury or death was reported.
The Centurion primary warmer pack was only distributed to St. Luke’s Health System in Idaho.
The release added that the Vyaire cartridge was the main focus of the recall, but the warmer pack also contains the Becton Dickinson (NYSE:BDX) Alaris pump model 8100 infusion set, which was also recalled due to non-uniform wall thickness of silicone segments, potentially causing failure to occlude tubing.