CLASS II Device recall · Reported 11 Feb 2015 · FDA Enforcement Report

SmartSite Low Sorbing Infusion Set recalled by CareFusion 303

CareFusion 303 is recalling SmartSite Low Sorbing Infusion Set, distributed nationwide in the US. The recall was initiated on 13 Jan 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot No. 12056016, 12057027, and 12107105.

Quantity recalled7,440 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-1053-2015
FDA event ID: 70260
Recalling firm: CareFusion 303, San Diego, CA
Classification: Class II
Status: Terminated
Recall initiated: 13 Jan 2015
FDA classified: 4 Feb 2015
Reported: 11 Feb 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Heart & Vascular Devices

Timeline

13 Jan 2015	Recall initiated by company
4 Feb 2015	Classified by FDA	+22 days
11 Feb 2015	Published in enforcement report	+7 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 SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.

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

SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a SmartSite bag access port, a non-vented drip chamber, roller clamp, infusion pump segment, a male luer, and low sorbing tubing.

Where it was distributed

Nationwide Distribution

Nationwide

Questions about this recall

Is SmartSite Low Sorbing Infusion Set recalled?

Yes. CareFusion 303 recalled SmartSite Low Sorbing Infusion Set on 13 Jan 2015. The recall is Class II and its status is Terminated. Recall number Z-1053-2015.

Why was it recalled?

CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.

Which lots are affected?

Lot No. 12056016, 12057027, and 12107105.

Where was it sold?

Nationwide Distribution

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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