ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue
ICU Medical is recalling 15 units of 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 failure (guidewire cannot pass) rather than a direct safety hazard like contamination or structural failure causing injury.
Plain-English summary
ICU Medical, Inc. is recalling 15 units of Central Venous Catheters, Model # 50456-01. The recall is due to a defect where the guidewire is unable to pass through the needles included with the catheter kits.
The affected devices are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring. The specific lot number is 4350491/0 0840619 03011 7.
The devices were distributed to US consignees in 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. Users should stop using the affected devices and contact the manufacturer for 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. Model # 50456-01
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 15
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 - 4350491/0 0840619 03011 7
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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