CLASS II Device recall · Reported 11 Nov 2015 · FDA Enforcement Report
SmartSite Extension Set recalled by CareFusion 303
CareFusion 303 is recalling SmartSite Extension Set, distributed nationwide in the US. The recall was initiated on 9 Oct 2015 and the FDA has classified it as Class II.
Check your package
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-0221-2016
- FDA event ID
- 72384
- Recalling firm
- CareFusion 303, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Oct 2015
- FDA classified
- 5 Nov 2015
- Reported
- 11 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 9 Oct 2015 | Recall initiated by company | |
| 5 Nov 2015 | Classified by FDA | +27 days |
| 11 Nov 2015 | 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 SmartSite Extension 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 Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
Where it was distributed
Distributed US (nationwide) and in Canada.
Questions about this recall
Is SmartSite Extension Set recalled?
Yes. CareFusion 303 recalled SmartSite Extension Set on 9 Oct 2015. The recall is Class II and its status is Terminated. Recall number Z-0221-2016.
Why was it recalled?
CareFusion is recalling the SmartSite Extension Set due to disconnection and leakage issues.
Which lots are affected?
Lot No. 15015769, 15035412, 15045950.
Where was it sold?
Distributed US (nationwide) and in 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 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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