Company: ICU Medical Inc
Date of Enforcement Report: 12/17/2018
Class II

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.

Recall Number: Z-0619-2019

REASON

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

RECALLING FIRM/MANUFACTURER

ICU Medical Inc, LAKE FOREST, IL on 11/8/2018. Voluntary: Firm Initiated, recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
31,050 units

DISTRIBUTION
U.S. Nationwide and Canada