ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
ICU Medical is recalling IV sets with drip chambers due to potential black specks and particulate matter in the fluid path.
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 involves a medical device with a potential risk of particulate matter entering the fluid path, which poses a risk of harm to patients, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling IV Sets with drip chambers. The recall affects approximately 100.7 million units distributed worldwide, including across the United States and several international territories.
The recall was initiated because the drip chambers may contain black specks, potentially caused by discolored polyvinyl chloride (PVC) material left in the chamber wall during the plastic molding process. The presence of discoloration and particulate matter in the fluid path has not been ruled out.
Healthcare facilities and consumers should stop using the affected IV sets and contact ICU Medical for further instructions or a replacement.
The recalled product
- Product
- IV Sets with drip chambers
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 100,712,657
Distribution
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