ICU Medical Recalls Central Venous Catheters Due to Guidewire Issue
ICU Medical is recalling 235 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 source text describes a functional defect (inability to pass guidewire) without reporting any injuries, illnesses, or deaths. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary recalls where harm has not been reported.
Plain-English summary
ICU Medical, Inc. is recalling 235 units of Central Venous Catheters, Model # 41414-23. These devices are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients.
The recall was initiated because the guidewire is unable to pass through the needles included with the catheter kits. This defect prevents the intended use of the device for 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 4156000/1 0840619 04647 4, 4174850/1 0840619 04647 4, 4192313/1 0840619 04647 4, 4330831/1 0840619 04647 4, and 4365303/1 0840619 04647 4. Healthcare providers should check their inventory for these specific lot numbers and stop using the affected devices.
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 # 41414-23
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 235
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 - 4156000/1 0840619 04647 4
- 4174850/1 0840619 04647 4
- 4192313/1 0840619 04647 4
- 4330831/1 0840619 04647 4
- 4365303/1 0840619 04647 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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