ICU Medical Recalls Cardiac Catheterization Waste Management Systems
ICU Medical is recalling Cardiac Catheterization Waste Management Systems due to a molding defect in a high pressure stopcock that could cause side ports to become occluded.
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. The defect involves a molding issue that could occlude ports, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
ICU Medical, Inc. is recalling Cardiac Catheterization Waste Management Systems with a 1000mL Waste Bag and 2 Fluid Admin Sets. The recall is due to a molding defect in a high pressure stopcock where a small percentage of the side ports could become totally occluded.
The affected product is identified by Part Number 460730418, 510(k) K052865, and Lot number 2444750. The product was distributed nationwide.
Consumers and healthcare facilities should stop using the affected units and contact ICU Medical for further instructions.
The recalled product
- Product
- Cardiac Catheterization Waste Management System w/1000mL Waste Bag, 2 Fluid Admin Sets Product Usage: For waste managment.
- Manufacturer
- ICU Medical, Inc.
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)
- Part Number 460730418 510(k) K052865 Lot number 2444750
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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