ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
ICU Medical is recalling IV sets with drip chambers because black specks may be present in the fluid path due to a plastic molding issue.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves potential particulate matter in a medical device used for intravascular administration, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling IV Sets with drip chambers. The recall involves 56,553,672 units distributed worldwide, including nationwide distribution across all US states and territories and several international countries.
The recall was initiated because the drip chambers may contain black specks. This discoloration is potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of this discoloration and particulate matter in the fluid path has not been ruled out.
The affected products are all units manufactured on or before July 4, 2026. Specific UDI-DI codes are listed in the official recall documentation. Healthcare facilities and consumers should check their inventory for these specific product codes and discontinue use if the product matches the description.
The recalled product
- Product
- IV Sets with drip chambers
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 56,553,672
Distribution
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