ICU Medical Inc recalls SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV, 123 Inch, List Number 16373-02 Sapphire Epidura…

Recall date

November 8, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0619-2019

FDA classification

Class II

Brand / firm

ICU Medical Inc

Sold / distributed

US distribution and Internationally to Canada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.