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 Low Sorbing Infusion Set, Model# 10015048, because there is a potential for separation at the tubing sleeve below the drip chamber. |
| Product | SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set. |
| Quantity | 15860 units |
| Distribution | Nationwide in US: PA, OK, TX, FL, NC, CA, IN, WI |
| Initiated | 2013-08-30 |
| Classified | 2013-09-26 |
| Terminated | 2014-04-16 |
| Recall number | Z-2285-2013 |
| 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-2285-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/66151/
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