SmartSite Extension Set — Class II medical device recall Z-1459-2014
Terminated recall by CareFusion 303, Inc., reported 2014-04-23, distributed nationwide. Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.
| Recall number | Z-1459-2014 |
|---|---|
| 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 | 2014-03-19 |
| Classified | 2014-04-15 |
| Reported by FDA | 2014-04-23 |
| Terminated | 2015-06-06 |
| Distributed | Nationwide (US) |
| Quantity | 7,700 units |
| Reason classes | packaging |
| Lot numbers | 13085791 |
| Model numbers | 20029E |
Product
SmartSite Extension Set, Model No. 20029E, intravascular administration set.
Reason for recall
Disconnections and leakages at the connection of the smallbore tubing and the SmartSite Y-port.
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-1459-2014. 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.