Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Infusion Pump I.V. Administration Recalled by ICU Medical Inc Due to Potential for fluid leakage out of air vents...
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
Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Epidural Set Yellow-Striped Microbore, 0.2 Micron Filter, PAV 123 inch. 1 unit per pouch; 50 pouches per case
Quantity: 26,700 units
Why Was This Recalled?
Potential for fluid leakage out of air vents on inline filters on Plum and Sapphire micropore infusion sets.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
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