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 Alaris Pump Module SmartSite Infusion Set because the disconnection and leakage may occur during infusion. |
| Product | Alaris Pump SmartSite Infusion Set, Model No. 2420-0500. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. |
| Quantity | 1,445,180 units |
| Distribution | Worldwide Distribution-US (nationwide) and the countries of Canada, Australia, and New Zealand. |
| Initiated | 2015-11-05 |
| Classified | 2015-12-23 |
| Terminated | 2017-03-01 |
| Recall number | Z-0445-2016 |
| 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-0445-2016).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/72583/
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