# FDA recall Z-0356-2024

> **Sage Products Inc** · Class II · device recall initiated 2023-10-23.

## Product

stryker Sage PrimaFit External Urine Management System for the Female Anatomy

## Reason for recall

A small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is not declared on the label

## Distribution

US and Canada

## Key facts

- **Recall number:** Z-0356-2024
- **Recalling firm:** Sage Products Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-10-23
- **Report date:** 2023-11-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cary, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0356-2024

## Citation

> AI Analytics. FDA recall Z-0356-2024. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-0356-2024. Source: US FDA. Licensed CC0.

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