FDAJuly 29, 2019device
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.
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
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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