ICU Medical—Plum and Sapphire Microbore Administration Sets with Inline Filters: Fluid May Leak out of Air Vents

August 14, 2019 | Strategic Insights for Health System


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In a July 29, 2019, Urgent Medical Device Correction letter submitted by ECRI Institute member hospitals, ICU Medical states that it has received reports of small amounts of fluid leaking from the air vents on the inline filters of the above infusion sets. ICU Medical also states that fluid leakage may delay infusion and lead to medication underdelivery, contamination of the fluid path, exposure to hazardous medications, or air in the fluid path line. ICU Medical further states that it has received...

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