Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Spinning Spiros Recalled by ICU Medical, Inc. Due to Potential for spinning versions of male luers to...
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
Spinning Spiros, Closed Male Luer, REF: 060-CH2000S; SURPLUG ChemoAccess Closed Male Luer, REF: 066-CH2000S; SURPLUG ChemoAccess 5" (13cm) Bag Spike Adaptor with Closed Male Luer, REF: 066-CH3034; 35" (89 cm) Appx 3.9 ml, 10 Drop Admin Set w/Integrated Clave Drip Chamber, Clave, Spiros w/Red Cap, Bag Hanger, REF: CH3762; 35" (89 cm) Appx 6.6 ml, 10 Drop Admin Set w/Integrated Clave Drip Chamber, 0.2 Micron Low Protein Binding Filter, Clave, Spiros w/Red Cap, Bag Hanger, REF: CH3763
Quantity: 33900
Why Was This Recalled?
Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.
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