FDA Device recall Z-1053-2015
SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a n…
- FDA Device
- Class II
- terminated
- Published 2015-02-11
On 2015-02-11 the FDA classified a Class II recall of SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a n… by Carefusion 303, citing careFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1053-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-13 |
| Published | 2015-02-11 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carefusion 303 |
| Distribution | US |
Product
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.
Reason
CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues.
Identifiers
| code_info | Lot No. 12056016, 12057027, and 12107105. |
|---|
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-1053-2015%22
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