Device recall
Z-1991-2020: Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL…
FDA device recall · Class II · Covidien Llc
Key facts
| Recall number (Z-number) | Z-1991-2020 |
|---|---|
| Recall event | 85629 |
| Product | Dover 100% Silicone Silver-Hydrogel Coated Premium Urine Meter Foley Tray 400mL, Premium, Urine Meter, 16 Fr/Ch (5.3 mm), 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Luer-Lock Sampling, Temperature Sensor and Adhesive Catheter Securement, Sterile, Product Code P4P16XTSD - Product Usage… |
| 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