Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SAPPHIRE Epidural Set Yellow-Striped Microbore Recalled by ICU Medical Inc Due to There have been reports of distal occlusion alarms...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact ICU Medical Inc directly.
Affected Products
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.
Quantity: 31,050 units
Why Was This Recalled?
There have been reports of distal occlusion alarms during the use of SAPPHIRE Epidural Set Yellow-Striped administration sets.
Where Was This Sold?
US distribution and Internationally to Canada.
About ICU Medical Inc
ICU Medical Inc has 50 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report