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 due to disconnection and leakage issues. |
| Product | SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a SmartSite bag access port, a non-vented drip chamber, roller clamp, infusion pump segment, a male luer, and low sorbing tubing. |
| Quantity | 7,440 units |
| Distribution | Nationwide Distribution |
| Initiated | 2015-01-13 |
| Classified | 2015-02-04 |
| Terminated | 2016-03-15 |
| Recall number | Z-1053-2015 |
| 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-1053-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/70260/
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