medical Class II Updated 2020-05-20

ICU Medical, Inc. recalls Central Venous Catheters are indicated for the assessment of

Recalled Product

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

Hazard / Issue

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

Issued by

FDA

Affected States: AL, CA, FL, GA, IL, ME, MI, MN, MS, NC, NH, NM, NY, OH, TX, UT, VA, WA

Lot/Code Info: LOT 4330832 UDI:1 0840619 04197 4

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