Device recall
Z-1970-2025: Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With…
FDA device recall · Class II · BD SWITZERLAND SARL
Key facts
| Recall number (Z-number) | Z-1970-2025 |
|---|---|
| Recall event | 96737 |
| Product | Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded Texium With Priming Cap Back Check Valve 2 SmartSite Y-Sites, REF: 10013361T; SmartSite Bag Access Non-Vented Bonded Texium Closed Male Luer With Priming Cap, REF: 10321213T; SmartSite Bag Access Non-Vented Low Sorbing Tubing (PE… |
| Product code | FPA |
| Recalling firm | BD SWITZERLAND SARL |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K053049 |
| FEI number | 3012798826 |
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