CareFusion Recalls Trifurcated Extension Sets Due to Potential Component Leak
CareFusion 303, Inc. is recalling Trifurcated Extension Sets (models ME 1224 and MP 9230) because a defect in the trifurcated component could result in a 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 is classified as FDA Class II and involves a medical device defect that poses a risk of harm (leakage) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
CareFusion 303, Inc. is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230. The recall involves 9,550 units that were distributed nationwide in the US and Canada.
The recall is being conducted because the products may have a defect in the trifurcated component that could result in a component leak. The source text does not report any specific injuries or illnesses associated with this defect.
Healthcare facilities and consumers should stop using the affected products and contact CareFusion 303, Inc. for further instructions on how to return or dispose of the units.
The recalled product
- Product
- Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
- Manufacturer
- CareFusion 303, Inc.
- Affected units
- 9,550
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 (3)
- Trifurcated Extension Set
- Model No. ME 1224
- Model No. MP 9230 Lot No. 13015666.
Distribution
Distributed nationwide across the United States.
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