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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

ICU Medical, Inc.: Inability for the guidewire to pass through the needles included with the catheter kits.

Agency Publication Date: May 14, 2020
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Affected Products

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

LOT 4330832 UDI:1 0840619 04197 4

Lot Numbers:
4330832
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.

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

Lot Numbers:
Number
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 # 41401-25.

LOT Number/ UDI-4156005/1 0840619 04410 4

Lot Numbers:
Number
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 # 41406-23

LOT Number/ UDI-4155999/1 0840619 04642 9, 4192320/1 0840619 04642 9

Lot Numbers:
Number
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 # 41411-25

LOT Number/ UDI-4192314/1 0840619 04645 0

Lot Numbers:
Number
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 # 41414-23

LOT Number/ UDI - 4156000/1 0840619 04647 4, 4174850/1 0840619 04647 4, 4192313/1 0840619 04647 4, 4330831/1 0840619 04647 4, 4365303/1 0840619 04647 4

Lot Numbers:
Number
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 # 50456-01

LOT Number/ UDI - 4350491/0 0840619 03011 7

Lot Numbers:
Number

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 85361
Status: Resolved
Manufacturer: ICU Medical, Inc.
Manufactured In: United States
Units Affected: 7 products (20; 260 units; 10; 60; 10; 235; 15)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.