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 Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter 301 cm / 8.3 mL. 1 unit per blister; 40 blisters per case . Not distributed in the U.S.
Hazard / Issue
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Issued by
FDA
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