CLASS II Device recall · Reported 12 Feb 2014 · FDA Enforcement Report

Trifurcated Extension Set recalled by CareFusion 303

CareFusion 303 is recalling Trifurcated Extension Set, distributed nationwide in the US. The recall was initiated on 16 Jan 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesTrifurcated Extension Set, Model No. ME 1224, Lot No. 11066540 11075718 11085047 11086237 11086676 11095178 11096312 11106045 11126756 12025801 12037064 12037127 12065225 12065586 12076327 12095460 13025322 13035514 13076233 13085002 Trifurcated Extension Set, Model No. MP 9230 Lot No. 13015666.

Quantity recalled9,550 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0931-2014
FDA event ID: 67326
Recalling firm: CareFusion 303, San Diego, CA
Classification: Class II
Status: Terminated
Recall initiated: 16 Jan 2014
FDA classified: 4 Feb 2014
Reported: 12 Feb 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

16 Jan 2014	Recall initiated by company
4 Feb 2014	Classified by FDA	+19 days
12 Feb 2014	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they may have a defect in the trifurcated component that could result in a component leak.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.

Where it was distributed

Nationwide in US and Canada

Nationwide

Questions about this recall

Why was it recalled?

CareFusion is recalling the Trifurcated Extension Set, models ME 1224 and MP 9230, because they may have a defect in the trifurcated component that could result in a component leak.

Which lots are affected?

Trifurcated Extension Set, Model No. ME 1224, Lot No. 11066540 11075718 11085047 11086237 11086676 11095178 11096312 11106045 11126756 12025801 12037064 12037127 12065225 12065586 12076327 12095460 13025322 13035514 13076233 13085002 Trifurcated Extension Set, Model No. MP 9230 Lot No. 13015666.

Where was it sold?

Nationwide in US and Canada

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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