Recall – Distal occlusion alarm

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

FDA and 62304 Training – Boston – June 4-6, 2019

3-day course is designed to gain an understanding of how 62304 and other standards can be implemented efficiently and effectively while meeting FDA expectations as well.  John F. Murray, Jr., will be among the faculty!
The discounted April registration expires on April 30, 2019, or when all discounted seats are sold.

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