FDA Device recall Z-2025-2014
SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
- FDA Device
- Class II
- terminated
- Published 2014-07-16
On 2014-07-16 the FDA classified a Class II recall of SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458 by Carefusion 303, citing careFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2025-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-06-17 |
| Published | 2014-07-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carefusion 303 |
| Distribution | FL, NM, TX, WA, WI |
Product
SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
Reason
CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip chamber has a 15 micron filter and it does not provide the instruction that the set should not be used with blood administration due to the potential for occluding the 15 micron filter in the drip c
Identifiers
| code_info | Lot No. 14035485 14046894 14035458 14035457 |
|---|
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-2025-2014%22
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