Device recall
Z-2764-2018: Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number…
FDA device recall · Class II · Degania Silicone, Ltd.
Key facts
| Recall number (Z-number) | Z-2764-2018 |
|---|---|
| Recall event | 80641 |
| Product | Foley Catheter with temperature sensor 400TM 12FR, Catalogue Number 102201101280TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and… |
| Product code | EZL |
| Recalling firm | Degania Silicone, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 25, 2024 |
| 510(k) numbers | K063442 |
| FEI number | 7682 |
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