CLASS II Device recall · Reported 2 Oct 2013 · FDA Enforcement Report

CareFusion Gravity Set recalled by CareFusion 303

CareFusion 303 is recalling CareFusion Gravity Set, distributed in Illinois. The recall was initiated on 30 Aug 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Numbers: 12086930, 12106215, 13016408, 13016834, 13025446, and 13025672.

Quantity recalled2,850 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-2281-2013
FDA event ID: 66152
Recalling firm: CareFusion 303, San Diego, CA
Classification: Class II
Status: Terminated
Recall initiated: 30 Aug 2013
FDA classified: 26 Sep 2013
Reported: 2 Oct 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

30 Aug 2013	Recall initiated by company
26 Sep 2013	Classified by FDA	+27 days
2 Oct 2013	Published in enforcement report	+6 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 Gravity Set (Model 44000-07) because of an incorrect expiration date. The affected lot numbers of the Gravity Set are labeled with a 5 year expiration instead of three (3) years.

Product as listed by the FDA

CareFusion Gravity Set, Model #44000-07 The CareFusion Gravity Sets are used to administer fluid and medication through a needle or catheter inserted into the patient's artery or vein. The CareFusion Gravity Set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a check valve, injection ports, 4-way stopcock, anti-siphon valve, roller clamp and tubing.

Where it was distributed

Illinois

Questions about this recall

Is CareFusion Gravity Set recalled?

Yes. CareFusion 303 recalled CareFusion Gravity Set on 30 Aug 2013. The recall is Class II and its status is Terminated. Recall number Z-2281-2013.

Why was it recalled?

Which lots are affected?

Lot Numbers: 12086930, 12106215, 13016408, 13016834, 13025446, and 13025672.

Where was it sold?

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 21 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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