ICU Medical, Inc. 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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
ICU Medical, Inc.
Lot Codes / Batch Numbers
LOT 4330832 UDI:1 0840619 04197 4
Products Sold
LOT 4330832 UDI:1 0840619 04197 4
ICU Medical, Inc. is recalling Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial due to Inability for the guidewire to pass through the needles included with the catheter kits.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Inability for the guidewire to pass through the needles included with the catheter kits.
Recommended Action
Per FDA guidance
The firm has contracted Stericycle, Inc., Indianapolis, IN for customer notification, response tracking and effectiveness check. On 02 January 2020, Stericycle, Inc. sent URGENT: MEDICAL DEVICE RECALL notification of the market action to the firm's direct consignees of record.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AL, CA, FL, GA, IL, IN, ME, MI, MN, MS, NH, NM, NY, NC, OH, TX, UT, VA, WA
Page updated: Jan 10, 2026