ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue
ICU Medical is recalling 10 Central Venous Catheters because the included guidewire cannot pass through the needles.
What this means for you
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 defect is a functional issue (guidewire cannot pass through needle) rather than a direct safety hazard like infection or injury, fitting the Moderate category for minor functional defects.
Plain-English summary
ICU Medical, Inc. is recalling 10 units of Central Venous Catheters, Model # 41401-25. 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 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 Canada. The specific lot number is 4156005/1 0840619 04410 4.
Consumers and healthcare facilities should stop using the affected catheters and contact ICU Medical, Inc. for further instructions or 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 # 41401-25.
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Catheters
- Hazard
- 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-4156005/1 0840619 04410 4
Distribution
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.
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