Class II — CareFusion 303, Inc.
| Recalling firm | CareFusion 303, INC. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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 |
| 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. |
| Quantity | 3,500,000 units (2,136,200 units in US; 1,404,700 units foreign) |
| Distribution | Worldwide Distribution: US (nationwide) including Puerto Rico; and internationally to: Australia, Canada and New Zealand. |
| Initiated | 2014-01-22 |
| Classified | 2014-02-03 |
| Terminated | 2015-08-06 |
| Recall number | Z-0925-2014 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — CareFusion 303, Inc. (Z-0925-2014).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/67346/
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