Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2000-2020·Announced 2020-05-20

ICU Medical Recalls Central Venous Catheters Due to Guidewire Defect

ICU Medical is recalling 10 Central Venous Catheters because the included guidewire cannot pass through the needles. The defect prevents proper use of the device.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The defect is a functional failure (guidewire cannot pass) rather than a direct safety hazard like infection or injury, and no injuries are reported.

Plain-English summary

ICU Medical, Inc. is recalling 10 units of Central Venous Catheters, Model # 41411-25. The recall is due to a defect where the guidewire is unable to pass through the needles included with the catheter kits. This issue prevents the proper use of the device for hemodynamic status assessment.

The affected units were distributed to consignees in the United States, including the states of Alabama, California, Florida, Georgia, Illinois, Maine, Michigan, Minnesota, Mississippi, North Carolina, New Hampshire, New Mexico, New York, Ohio, Texas, Utah, Virginia, and Washington, as well as to consignees in Canada. The specific lot number for the recalled units is 4192314/1 0840619 04645 0.

Healthcare providers and consumers should stop using the affected catheters immediately. Users should contact ICU Medical, Inc. for instructions on how to return the product or obtain a replacement.

The recalled product

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
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Catheters
Hazard: functional-defect
Affected units: 10

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

LOT Number/ UDI-4192314/1 0840619 04645 0

Distribution

Distributed in 19 states:

Part of a larger recall action

This product is one of 7 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

Same manufacturer · ICU Medical, Inc.

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