Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
6.5 IN (17 cm) APPX 0.78 ml Recalled by ICU Medical, Inc. Due to Due to a manufacturing defect which results in...
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
6.5 IN (17 cm) APPX 0.78 ml, EXT SET w/Clave CLEAR, Clave 4-WAY Stopcock, Spiros, RED CAP. Accessory for intravascular administration set.
Quantity: Total of all affected units = 5,795,989 units
Why Was This Recalled?
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
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