Device recall
Z-1053-2015: SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion…
FDA device recall · Class II · CareFusion 303, Inc.
Key facts
| Recall number (Z-number) | Z-1053-2015 |
|---|---|
| Recall event | 70260 |
| 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… |
| Product code | FPA |
| Recalling firm | CareFusion 303, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 15, 2016 |
| 510(k) numbers | K960280 |
| 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