# FDA recall Z-2783-2018

> **Degania Silicone, Ltd.** · Class II · device recall initiated 2018-06-21.

## Product

Temperature sensing catheter 18FR, Catalogue Number 102203101863DO    Product Usage:  This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

## Reason for recall

The catheters are suspected to contain defective sensors; if used, defective catheter will show lower body temperature than the actual body temperature of a patient.

## Distribution

Worldwide Distribution - US Nationwide in the states: IL, NC, NY and the countries of : Belgium, Israel, Japan, and Mexico.

## Key facts

- **Recall number:** Z-2783-2018
- **Recalling firm:** Degania Silicone, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-06-21
- **Report date:** 2018-09-26
- **Termination date:** 2024-10-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dganya Bet, N/A, Israel

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2783-2018

## Citation

> AI Analytics. FDA recall Z-2783-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-2783-2018. Source: US FDA. Licensed CC0.

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