# FDA recall Z-0809-2020

> **Degania Silicone, Ltd.** · Class II · device recall initiated 2019-12-02.

## Product

Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile  Catalog Number: 102201101463MD {Medline code 55346)    Monitor urinary output and bladder temperature in addition to facilitating urine drainage.

## Reason for recall

Temperature deviation did not meet release specifications

## Distribution

US Distribution to IL

## Key facts

- **Recall number:** Z-0809-2020
- **Recalling firm:** Degania Silicone, Ltd.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-12-02
- **Report date:** 2020-01-22
- **Termination date:** 2020-10-22

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0809-2020

## Citation

> AI Analytics. FDA recall Z-0809-2020. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/Z-0809-2020. Source: US FDA. Licensed CC0.

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