FDA Device recall Z-1788-2020
Temperature Sensing 100% Silicone Foley Catheter, Part Number 102203101663DO - 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 102203101663DO - 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-1788-2020 |
| 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 102203101663DO - 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: V18024145 V18024144 V18027064 V18026042 V18026043 V18026045 V18029205 V18029206 V18037913 V180493…Lot Numbers: V18024145 V18024144 V18027064 V18026042 V18026043 V18026045 V18029205 V18029206 V18037913 V18049310 V19007111 V19007110 V19008666 V19008664 V19009594 V19013277 V19027814 V19027863 V19027865 |
|---|
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-1788-2020%22
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