Device recall
Z-1783-2020: Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD…
FDA device recall · Class II · Degania Medical Devices Pvt. Ltd.
Key facts
| Recall number (Z-number) | Z-1783-2020 |
|---|---|
| Recall event | 85327 |
| Product | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101663MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder. |
| Product code | EZL |
| Recalling firm | Degania Medical Devices Pvt. Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 25, 2024 |
| 510(k) numbers | K063442 |
| FEI number | 3005483737 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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