FDA Device recall Z-2285-2013
SmartSite Low Sorbing Infusion Set, Model# 10015048
- FDA Device
- Class II
- terminated
- Published 2013-10-02
On 2013-10-02 the FDA classified a Class II recall of SmartSite Low Sorbing Infusion Set, Model# 10015048 by Carefusion 303, citing careFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2285-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-08-30 |
| Published | 2013-10-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carefusion 303 |
| Distribution | US |
Product
SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
Reason
CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber.
Identifiers
| code_info | Lot Numbers 13015883 and 13025342. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2285-2013%22
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