Drug recall
SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer…
FDA recall event 70260 · Class II · CareFusion 303, Inc.
Key facts
| Event ID | 70260 |
|---|---|
| Recall numbers | Z-1053-2015 |
| Recalling firm | CareFusion 303, Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CareFusion is recalling the SmartSite Low Sorbing Infusion set due to disconnection and leakage issues. |
| Initiation date | Jan 13, 2015 |
| Report date | Feb 11, 2015 |
| Termination date | Mar 15, 2016 |
| City | San Diego |
| State | CA |
| Country | United States |
| FEI number | 2016493 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: