Drug recall
SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set.
FDA recall event 66151 · Class II · CareFusion 303, Inc.
Key facts
| Event ID | 66151 |
|---|---|
| Recall numbers | Z-2285-2013 |
| Recalling firm | CareFusion 303, Inc. |
| Product type | Devices |
| Products | SmartSite Low Sorbing Infusion Set, Model# 10015048. Intravascular administration set. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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. |
| Initiation date | Aug 30, 2013 |
| Report date | Oct 2, 2013 |
| Termination date | Apr 16, 2014 |
| 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: