The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1997-2020·Announced 2020-05-20

ICU Medical Recalls Central Venous Catheters Due to Guidewire Defect

ICU Medical is recalling 260 units of Central Venous Catheters because the included guidewire cannot pass through the needles.

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 corresponds to a moderate severity score when no specific injuries or hospitalizations are reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling 260 units of Central Venous Catheters, Model # 41401-23. The recall is due to a defect where the guidewire is unable to pass through the needles included with the catheter kits. These devices are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring.

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. The specific lot numbers and UDI codes for the recalled units are 4155346/1 0840619 04409 8, 4174851/1 0840619 04409 8, 4192312/1 0840619 04409 8, 4330851/1 0840619 04409 8, and 4351191/1 0840619 04409 8.

Healthcare facilities and consumers should check their inventory for these specific lot numbers and discontinue use of the affected catheters. The FDA has classified this as a Class II recall, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.

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 # 41401-23.
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Catheters
Hazard
Affected units
260

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 (5)

  • 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

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 →

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