ICU Medical, Inc. recalls Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular…

Recall date

January 2, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1996-2020

FDA classification

Class II

Brand / firm

ICU Medical, Inc.

Sold / distributed

US Consignees including in the states of AL, CA, FL, GA, IL, ME, MI, MN, MS, NC, NH, NM, NY, OH, TX, UT, VA and WA OUS - Canada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4