SmartSite Needleless Connector — Class II medical device recall Z-0925-2014
Terminated recall by CareFusion 303, Inc., reported 2014-02-12, distributed nationwide. CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues.
| Recall number | Z-0925-2014 |
|---|---|
| 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 | 2014-01-22 |
| Classified | 2014-02-03 |
| Reported by FDA | 2014-02-12 |
| Terminated | 2015-08-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, NZ |
| Reason classes | packaging, device malfunction |
| Lot numbers | 13045933, 13046117, 13086415, 13086446, 13095237, 13095302, 13095324, 13095579, 13095674, 13095675, 13095777, 13095778, 13095808, 13095944, 13096011, 13096012, 13096013, 13096158, 13096723, 13096770, 13105584, 13106017, 13106018, 13106096, 13106260, 13106355, 13106451, 13106497, 13106498, 13106753, 13106754, 13106847, 13106848, 13106849, 13115209, 13115210, 13115317, 13115733, 13115734, 13115871 and 3 more |
| Model numbers | 2000E |
Product
SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The needle free connector allows the user to add medication into the primary line without the use of a needle.
Reason for recall
CareFusion is recalling the SmartSite Needlefree Connector, model number 2000E, because of connection issues. The affected SmartSite connector lots may unintentionally disconnect from a female luer, may be difficult to disconnect from a female luer, or may fail to disconnect from a female luer once attached. Leakage may also be observed if the connector disconnects from the female luer during in
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-0925-2014. 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.