ICU Medical, Inc.: Medical Device Recall in 2020 - (Recall #: Z-1997-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

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 # 41401-23.

Product Classification:

Class II

Date Initiated: January 2, 2020

Date Posted: May 20, 2020

Recall Number: Z-1997-2020

Event ID: 85361

Reason for Recall:

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

Status: Terminated

Product Quantity: 260 units

Code Information:

LOT Number/ UDI-4155346/1 0840619 04409 8, 4174851/1 0840619 04409 8, 4192312/1 0840619 04409 8, 4330851/1 0840619 04409 8, 4351191/1 0840619 04409 8

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated