The Recall Desk
HighFDA (Devices)·Z-0931-2014·Announced 2014-02-12

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.

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 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.
Category
Medical Device — Surgical/Infusion Equipment
Hazard
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.

Related recalls

Same manufacturer · CareFusion 303, Inc.

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Same hazard · leakage

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