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. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4
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
20
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. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1996-2020Don't want to check this manually?
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