FDA Device recall Z-1785-2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor…
- FDA Device
- Class II
- terminated
- Published 2020-04-29
On 2020-04-29 the FDA classified a Class II recall of Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor… by Degania Medical Devices Pvt, citing inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1785-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-03-17 |
| Published | 2020-04-29 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Degania Medical Devices Pvt |
| Distribution | US |
Product
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102202101663DO - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder.
Reason
Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
Identifiers
| code_info | Lot Numbers: V18013621 V18014635 V18025989 V18029252 V18032217 V18031184 V19006387 V18049356 V18049355 V19008749 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1785-2020%22
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