# FDA recall Z-1785-2020

> **Degania Medical Devices Pvt. Ltd.** · Class II · device recall initiated 2020-03-17.

## 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 for recall

Inadequate incoming inspection practices were utilized on thermistor sensors used in the production of the specified lots of temperature sensing catheters.

## Distribution

Worldwide distribution - US Nationwide distribution including  state of IL and the country of Mexico.

## Key facts

- **Recall number:** Z-1785-2020
- **Recalling firm:** Degania Medical Devices Pvt. Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-03-17
- **Report date:** 2020-04-29
- **Termination date:** 2024-10-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gurgaon, N/A, India

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1785-2020

## Citation

> AI Analytics. FDA recall Z-1785-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1785-2020. Source: US FDA. Licensed CC0.

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