Device recall
Z-1993-2020: Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley…
FDA device recall · Class II · Covidien Llc
Key facts
| Recall number (Z-number) | Z-1993-2020 |
|---|---|
| Recall event | 85629 |
| Product | Dover 400 ml 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray,18 Fr/Ch (6.0 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Temperature Sensor, Sterile, Product Code: P4P18XTS - Product Usage: for Drainage of the Urinary bladder and simultaneous monitoring of… |
| 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