Class II — Potential Health Hazard

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

Central Venous Catheters are indicated for the assessment of hemodynamic Recalled by ICU Medical, Inc. Due to Inability for the guidewire to pass through the...

Date: January 2, 2020
Company: ICU Medical, Inc.
Status: Terminated
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

Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 50456-01

Quantity: 15

Why Was This Recalled?

Inability for the guidewire to pass through the needles included with the catheter kits.

Where Was This Sold?

This product was distributed to 18 states: AL, CA, FL, GA, IL, ME, MI, MN, MS, NH, NM, NY, NC, OH, TX, UT, VA, WA

Affected (18 states)Not affected

About ICU Medical, Inc.

ICU Medical, Inc. has 592 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report