Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1996-2020·Announced 2020-05-20

ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue

ICU Medical is recalling 20 Central Venous Catheters because the included guidewire cannot pass through the needles. The product was distributed to US consignees and Canada.

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, and the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving a functional defect without reported harm.

Plain-English summary

ICU Medical, Inc. is recalling 20 units of Central Venous Catheters, identified by Lot Number 4330832 and UDI 1 0840619 04197 4. These devices are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring.

The recall was initiated because the guidewire included with the catheter kits is unable to pass through the needles. The affected units were distributed to US consignees in the states of AL, CA, FL, GA, IL, ME, MI, MN, MS, NC, NH, NM, NY, OH, TX, UT, VA, and WA, as well as to consignees in Canada.

Healthcare providers and consumers who have these specific units should stop using them and contact ICU Medical, Inc. for further instructions.

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. LOT Number 4330832. Product not distributed in US, UDI: 1 0840619 04197 4
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Catheters
Hazard: functional-defect
Affected units: 20

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 4330832 UDI:1 0840619 04197 4

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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