Device recall
Z-2025-2014: SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A…
FDA device recall · Class II · CareFusion 303, Inc.
Key facts
| Recall number (Z-number) | Z-2025-2014 |
|---|---|
| Recall event | 68608 |
| Product | SmartSite Low Sorbing Infusion Set, Model Codes: 10014855A, 10015861A, 10061661A 14035457 14035485 14046894 14035458 |
| Product code | FPA |
| Recalling firm | CareFusion 303, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 20, 2016 |
| 510(k) numbers | K944320 |
| FEI number | 2016493 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database