[Recalled] Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder. — Inadequate incoming inspectio
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Temperature Sensing 100% Silicone Foley Catheter, Part Number 102201101080MD - Product Usage: is a 3 lumen silicone catheter with a sensor to measure temperature while draining the urinary bladder. |
|---|---|
| Brand / manufacturer | Degania Medical Devices Pvt. Ltd. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1781-2020 |
| Country of notice | India |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 17 March 2020 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.
This Class II recall concerns device products distributed in India and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.