Device recall
Z-0800-2019: BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing…
FDA device recall · Class II · Bard Medical Division
Key facts
| Recall number (Z-number) | Z-0800-2019 |
|---|---|
| Recall event | 81750 |
| Product | BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature Sensing Infection Control Foley Catheter with Bard Hydrogel and Bacteria-Guard Silver Alloy Coating. Sterile. Intended for use in the drainage and/or collection and/or measurement of urine. |
| Product code | MJC |
| Recalling firm | Bard Medical Division |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K910318 |
| 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