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FDAJuly 29, 2019device

Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. 1 unit per pouch; 50 pouches per case

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

icu medicalicu

UPCs

2088778700743910887787007432

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, PAV, CLAVE Y-Site, 122 Inch. 1 unit per pouch; 50 pouches per case — Recall Details · AllClear