The company said Oct. 6 that the procedure packs contain Smiths Medical’s Normoflo irrigation warming set, which is used to provide more blood for patients suffering from blood loss from trauma or surgery, as well as to rewarm patients after surgery to prevent hypothermia.
The procedure packs are being recalled because of the potential for aluminum ions to leach into the warmed fluids. If this occurs, the contaminated fluid could circulate through a patient’s body, potentially exposing the patient to high levels of aluminum. Exposure to harmful levels of aluminum could cause cognitive decline, dementia, nervous system damage and even death.
Patients who have symptoms of aluminum exposure may experience bone or muscle pain or weakness, anemia, seizures or coma, the FDA said.
The FDA has classified the recall as class I, the most serious type of recall, meaning use of the product could cause serious injury or death. DeRoyal said it hasn’t received any reports of injuries or death.
Read the full news release here.
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