SmartSite Low Sorbing Infusion Set — Class II medical device recall Z-2285-2013
Terminated recall by CareFusion 303, Inc., reported 2013-10-02, distributed nationwide. CareFusion is recalling the SmartSite Low Sorbing Infusion Set, Model# 10015048, because there is a potential
| Recall number | Z-2285-2013 |
|---|---|
| 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 | 2013-08-30 |
| Classified | 2013-09-26 |
| Reported by FDA | 2013-10-02 |
| Terminated | 2014-04-16 |
| Distributed | Nationwide (US) |
| Quantity | 15,860 units |
| Lot numbers | 13015883, 13025342 |
| Model numbers | 10015048 |
Product
SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
Reason for recall
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.
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-2285-2013. 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.