CareFusion Recalls Alaris VersaSafe Infusion Sets Due to Leakage
CareFusion is recalling 5,760 Alaris VersaSafe Infusion Sets distributed in Michigan because the split septum port may separate or leak.
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 3/5 (High).
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 defect that may lead to leakage, representing a risk-of-harm product where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
CareFusion 303, Inc. is recalling the Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007. The recall involves 5,760 units from Lot No. 13085603 that were distributed in Michigan.
The recall is being conducted because of separation and/or leakages at the VersaSafe split septum port. This defect may lead to leakage of the administration set.
The source text does not specify specific instructions for consumers or healthcare providers regarding the disposition of the recalled units.
The recalled product
- Product
- Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Infusion Set
- Hazard
- Affected units
- 5,760
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 (1)
- Lot No. 13085603
Distribution
Distributed in 1 state:
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