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ICU Medical, Inc. recalls Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular,
Recalled May 20, 2020 · FDA recall Z-1997-2020 · ICU Medical
Hazard
Inability for the guidewire to pass through the needles included with the catheter kits. · FDA Class II
Units
260 units
Sold at
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.
Description
Inability for the guidewire to pass through the needles included with the catheter kits.
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. Model # 41401-23.
Manufacturer(s)
ICU Medical, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →