Device recall
Z-2154-2024: Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard…
FDA device recall · Class II · C.R. Bard Inc
Key facts
| Recall number (Z-number) | Z-2154-2024 |
|---|---|
| Recall event | 94722 |
| Product | Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control Temperature-Sensing Foley Catheter Tray with Bard Hydrogel and Bacti-Guard Silver Alloy Coating, 350 ml Urine Meter, 16 Fr, Catalog #319416AM. Intended for use in the… |
| Product code | MJC |
| Recalling firm | C.R. Bard Inc |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K040658 |
| FEI number | 1018233 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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