SmartSite Low Sorbing Infusion Set — Class II medical device recall Z-2025-2014
Terminated recall by CareFusion 303, Inc., reported 2014-07-16, distributed in FL, NM, TX, WA, WI. CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber
| Recall number | Z-2025-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | CareFusion 303, Inc., San Diego, CA, United States |
| Recall initiated | 2014-06-17 |
| Classified | 2014-07-09 |
| Reported by FDA | 2014-07-16 |
| Terminated | 2016-09-20 |
| Distributed | FL, NM, TX, WA, WI |
| Quantity | 5,600 units |
| Lot numbers | 14035457, 14035458, 14035485, 14046894 |
| Model numbers | 10014855A, 10015861A, 10061661A, 14035457, 14035458, 14035485, 14046894 |
Product
SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2025-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.