CLASS II Device recall · Reported 23 Mar 2016 · FDA Enforcement Report

Alaris Pump VersaSafe Infusion Set recalled by CareFusion 303

CareFusion 303 is recalling Alaris Pump VersaSafe Infusion Set, distributed in Michigan. The recall was initiated on 15 Feb 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot No. 13085603

Quantity recalled5,760 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-1179-2016
FDA event ID: 73238
Recalling firm: CareFusion 303, San Diego, CA
Classification: Class II
Status: Terminated
Recall initiated: 15 Feb 2016
FDA classified: 17 Mar 2016
Reported: 23 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Lead & Heavy Metals
Device type: Infusion Pumps

Timeline

15 Feb 2016	Recall initiated by company
17 Mar 2016	Classified by FDA	+31 days
23 Mar 2016	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 Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set.

Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.

Product as listed by the FDA

Alaris Pump VersaSafe Infusion Set, Model No. 2122-0007

Where it was distributed

Michigan

Questions about this recall

Is Alaris Pump VersaSafe Infusion Set recalled?

Yes. CareFusion 303 recalled Alaris Pump VersaSafe Infusion Set on 15 Feb 2016. The recall is Class II and its status is Terminated. Recall number Z-1179-2016.

Why was it recalled?

CareFusion is recalling the Alaris VersaSafe Infusion Set because of separation and/or leakages at the VersaSafe split septum port and tubing may lead to leakage of the administration set.

Which lots are affected?

Lot No. 13085603

Where was it sold?

Michigan

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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