ICU Medical Recalls IV Administration Sets with Incorrect Filter Assemblies
ICU Medical is recalling 1,100 units of smallbore IV administration sets due to incorrect filter assemblies. The products were distributed nationwide.
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 is typically associated with a temporary or medically reversible adverse health consequence. The source text does not report any specific injuries, illnesses, or deaths, and the defect is a manufacturing error (incorrect filter assemblies) rather than a high-risk pathogen or structural failure.
Plain-English summary
ICU Medical, Inc. is recalling 1,100 units of REF MC330209 6' (15 cm) Smallbore Trifuse Extension Sets. The recall was initiated because the products contain incorrect filter assemblies. The affected devices are single-use, sterile, non-pyrogenic intravascular administration sets used to provide access for the administration of fluids from a container to a patient's vascular system.
The affected products have the product code MC330209 and include lot numbers 4447222, 4536285, 4572773, and 4603405. These items were distributed nationwide, including in the states of Wisconsin, Massachusetts, California, Florida, Minnesota, Illinois, and New York.
Healthcare facilities and consumers should check their inventory for these specific lot numbers and stop using the affected sets. Users should contact ICU Medical for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- REF MC330209 6' (15 cm) Appx 0.09 ml, Smallbore Trifuse Ext Set w/3 MicroClave Clear, 0.2 Micron Filter, 1.2 Micron Filter, 3 Clamps (Blue, Yellow, White), Rotating Luer - Product Usage: The intravascular administration set is a single use, sterile, non-pyrogenic device, which…
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 1,100
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 (7)
- Product code : MC330209
- Lot numbers:4447222
- 4536285
- 4572773
- (01)10887709080543(17)241201(30)50(10)4536285
- (01)10887709080543(17)250101(30)50(10)4572773
- (01)10887709080543(17)250101(30)50(10)4603405
Distribution
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