# FDA recall Z-1012-2025

> **Trinity Sterile,  Inc.** · Class II · device recall initiated 2024-12-13.

## Product

Brand Name: IMed Products  Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD  Model/Catalog Number: IM46062  Software Version: N/A  Product Description: Dressing change kit, case of 30, lot #600022, 66 cases affected.  Component: No

## Reason for recall

Potential for hole in package compromising sterility of the medical kit.

## Distribution

US Nationwide distribution in the states of MD, PA, TN and TX.

## Key facts

- **Recall number:** Z-1012-2025
- **Recalling firm:** Trinity Sterile,  Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-13
- **Report date:** 2025-01-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Salisbury, MD, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1012-2025

## Citation

> AI Analytics. FDA recall Z-1012-2025. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1012-2025. Source: US FDA. Licensed CC0.

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