FDANovember 8, 2018device
SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidural Sets are indicated for the delivery of fluids from a container to a patient's epidural space. Sets are intended for use with Sapphire Infusion Systems.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.
What to do
FDA enforcement status: Terminated
Brands named
icu medicalicu
UPCs
108877870074
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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