US Infusion Recalls Medstream IV Sets Due to Leaking
US Infusion is recalling 62,700 Medstream IV infusion sets because they may leak at the Y site. The sets were distributed in six states.
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 involves a functional defect (leaking) that could compromise infusion integrity, but the source text does not report any injuries, illnesses, or hospitalizations, placing it in the moderate risk category.
Plain-English summary
US Infusion Inc dba Trucare Biomedix-USA is recalling 62,700 Medstream 81" (206 cm) 20 drop Universal Administration Sets. The recall was initiated after several complaints were received regarding the IV sets leaking at the Y site.
The affected product is a disposable IV infusion set with a 3-year expiration date. The specific items involved are Model # MS721, Lot # 20111115. These sets were distributed in the states of Texas, Illinois, Massachusetts, Ohio, California, and Georgia.
Consumers and healthcare facilities should stop using the affected IV sets and contact the recalling firm for further instructions or a refund.
The recalled product
- Product
- Medstream 81" (206 cm) 20 drop Universal Administration Sets. Disposable IV infusion set with 3 year expiration date.
- Manufacturer
- US Infusion Inc dba Trucare Biomedix-USA
- Hazard
- Affected units
- 62,700
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 (2)
- Model # MS721
- Lot # 20111115.
Distribution
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