Drug recall
SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894…
FDA recall event 68608 · Class II · CareFusion 303, Inc.
Key facts
| Event ID | 68608 |
|---|---|
| Recall numbers | Z-2025-2014 |
| Recalling firm | CareFusion 303, Inc. |
| Product type | Devices |
| Products | SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458 |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | CareFusion is recalling the SmartSite Low Sorbing Infusion Set because they were assembled with a drip chamber that consist of a 15 micron filter. The Directions For Use did not indicate that the drip… |
| Initiation date | Jun 17, 2014 |
| Report date | Jul 16, 2014 |
| Termination date | Sep 20, 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: