An announcement has been made regarding the recalling of Medline Primary Warmer Pack, which is used to help in the administering of intravenous (IV) fluids. The Medline Primary Warmer Pack constitutes several medical devices which are used during IV administration, including the Vyaire Medical enFlow Disposable Cartridge.
The enFlow Disposable Cartridge is required for warming blood, blood products, and intravenous solutions prior to administration of these fluids to help prevent hypothermia.
Reason for recalling the Primary Warmer Pack resides in containing the recalled Vyaire Medical enFlow Disposable Cartridge, which may eliminate aluminum into infused fluids during its usage, potentially exposing patients to aluminum at unsafe levels. Persistent use of these products may result in prolonged, undetected aluminum exposure and toxicity, which could result in neurocognitive complications (including an inability to concentrate, remember things, process information, learn, speak, and understand), bone marrow complications, or death.
The usage of affected product may cause serious adverse health consequences, which may not be easily linked to the affected product due to lack of awareness. Thus, signs and symptoms may be attributed to pre-existing illnesses or comorbidities as well as their respective treatments. Medline Industries received four customer complaints.
No serious injuries or deaths were reported.
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