medical Class II Updated 2018-12-26

ICU Medical Inc recalls SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron F

Recalled Product

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.


Hazard / Issue

There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.

Issued by

FDA

Distribution: US distribution and Internationally to Canada.
Lot/Code Info: UDI 108877870074, All codes
View official government recall

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