Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
REF CH3582 5 IN (13cm) APPX 0.57 ml Recalled by ICU Medical, Inc. Due to Due to molding defect, there is a potential...
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
REF CH3582 5 IN (13cm) APPX 0.57 ml, EXT SET, ANTI-SHIPHON VALVE, Spiros LOT 5125197 - Product Usage: for use in the preparation and patient administration of cytotoxic medications.
Why Was This Recalled?
Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About ICU Medical, Inc.
ICU Medical, Inc. has 592 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report