Device recall
Z-1985-2020: Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature…
FDA device recall · Class II · Covidien Llc
Key facts
| Recall number (Z-number) | Z-1985-2020 |
|---|---|
| Recall event | 85629 |
| Product | Dover 100% Silicone Silver-Hydrogel Coated Foley Catheter with Temperature Sensor 16FR 5CCCC2W, Product Code: 50516ICT - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of temperature. Prescription use only. |
| Product code | KOD |
| Recalling firm | Covidien Llc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 14, 2023 |
| 510(k) numbers | K933400 |
| FEI number | 1282497 |
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