FDA-Device2020-05-20Class II

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 # 41401-25.

ICU Medical, Inc.
Hazard

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

Sold states
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.
Affected count
10
Manufactured in
951 Calle Amanecer, N/A, San Clemente, CA, United States
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 # 41401-25.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1998-2020

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief