# FDA recall Z-0899-2018

> **Degania Silicone, Ltd.** · Class III · device recall initiated 2017-10-03.

## Product

Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile.  Catalog Number JP-2234.    Used for the drainage of body fluids for surgical use.

## Reason for recall

Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only.

## Distribution

US Distribution to Puerto Rico.

## Key facts

- **Recall number:** Z-0899-2018
- **Recalling firm:** Degania Silicone, Ltd.
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-10-03
- **Report date:** 2018-03-14
- **Termination date:** 2020-10-21

- **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-0899-2018

## Citation

> AI Analytics. FDA recall Z-0899-2018. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-0899-2018. Source: US FDA. Licensed CC0.

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