Device recall
Z-2462-2025: Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated…
FDA device recall · Class II · C.R. Bard Inc
Key facts
| Recall number (Z-number) | Z-2462-2025 |
|---|---|
| Recall event | 97041 |
| Product | Bardex Lubri-Sil I.C. 400-series Temperature Sensing Silver/Hydrogel Coated All-Silicone Foley Catheter 5cc Balloon, REF: 119314; SureStep Foley Tray System Lubri-Sil I.C. Complete Care, REF: A319514A; Bard Silver Lubri-Sil Foley Tray Temperature Sensing with Bard Hydrogel and Bacti-Guard Silver… |
| Product code | EZL |
| Recalling firm | C.R. Bard Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K070582 |
| FEI number | 1018233 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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