medical Class II Updated 2019-10-23

ICU Medical Inc recalls Infusion Pump I.V. Administration, specifically Sapphire Mic

Recalled Product

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore, PAV, 123 Inch. 1 unit per pouch; 50 pouches per case

Hazard / Issue

Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Product Code: 163840455, Lot number (UDI Number): 855995H (20887787007446, 10887787007449), 865505H (20887787007446, 10887787007449), 876185H (20887787007446, 10887787007449)
View official government recall

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