ICU Medical Recalls IV Administration Sets with Drip Chamber Specks
ICU Medical is recalling IV Non-Dedicated Gravity Administration Sets because black specks in the drip chamber may cause healthcare providers to delay therapy.
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 hazard is a cosmetic defect (discolored material not entering the fluid path) that may lead to a delay in therapy, fitting the criteria for a moderate severity recall without reported injuries.
Plain-English summary
ICU Medical, Inc. is recalling 2,450 units of IV Non-Dedicated Gravity Administration Sets with drip chambers. The recall covers products manufactured on or before July 4, 2026, which were distributed nationwide in the United States and in specific international locations including Pakistan, the Philippines, Malaysia, Hong Kong, India, Germany, and Costa Rica.
The recall was initiated because the drip chambers of the administration sets may contain black specks. These specks are potentially caused by the plastic molding process, which may leave discolored polyvinyl chloride (PVC) material within the drip chamber wall. The source text specifies that this material does not enter the fluid path.
If a healthcare provider observes these specks, they may replace the product before use. This action could result in a delay in patient therapy. No illnesses or injuries have been reported in the source text.
The recalled product
- Product
- IV Non-Dedicated Gravity Administration Sets with drip chambers
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 2,450
Distribution
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