PlainRecalls
FDA Devices Moderate Class II Terminated

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 # 41414-23

Reported: May 20, 2020 Initiated: January 2, 2020 #Z-2001-2020

Product Description

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 # 41414-23

Reason for Recall

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

Details

Recalling Firm
ICU Medical, Inc.
Units Affected
235
Distribution
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.
Location
San Clemente, CA

Frequently Asked Questions

What product 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. Model # 41414-23. Recalled by ICU Medical, Inc.. Units affected: 235.
Why was this product recalled?
Inability for the guidewire to pass through the needles included with the catheter kits.
Which agency issued this recall?
This recall was issued by the FDA Devices on May 20, 2020. Severity: Moderate. Recall number: Z-2001-2020.