Device recall
Z-0809-2020: Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number…
FDA device recall · Class II · Degania Silicone, Ltd.
Key facts
| Recall number (Z-number) | Z-0809-2020 |
|---|---|
| Recall event | 84510 |
| Product | Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage. |
| Product code | EZL |
| Recalling firm | Degania Silicone, Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 22, 2020 |
| 510(k) numbers | K063442 |
| FEI number | 7682 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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