The infusion sets have the potential for small amounts of fluid to leak out of the air vents on the inline filters. They were distributed nationwide to ICU Medical customers.
A fluid leakage could potentially cause a delay in the infusion of medicine to the patient, under-delivery of medication, contamination of the fluid path on the patient side of the filter, exposure to hazardous medications or air in the fluid path.
ICU Medical has not received any reports of adverse events related to the recall.
Read the full news release here.
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