Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

26 IN(66 cm) APPX 3.4ml Recalled by ICU Medical, Inc. Due to Potential for spinning versions of male luers to...

Date: August 31, 2020
Company: ICU Medical, Inc.
Status: Ongoing
Source: FDA (Device)

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

26 IN(66 cm) APPX 3.4ml, 10 DROP BLOOD SET, 170 MICRON FILTER, Spiros, REF: Z2795

Quantity: 2900

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.

Affected (51 states)Not affected

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