Device recall
Z-1970-2020: SureStep Foley Tray System - Product Usage: Intended for use in the drainage…
FDA device recall · Class II · C.R. Bard Inc
Key facts
| Recall number (Z-number) | Z-1970-2020 |
|---|---|
| Recall event | 85585 |
| Product | SureStep Foley Tray System - Product Usage: Intended for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other… |
| Product code | MJC |
| Recalling firm | C.R. Bard Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 20, 2021 |
| 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