# FDA recall Z-1104-2025

> **New Medical Technologies Gmbh** · Class II · device recall initiated 2024-12-19.

## Product

Integra Miltex Cryosolutions Cartridges 4 Pack (23.5g N2O each), Model: C-CA-23, Item: 33517;

## Reason for recall

During the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the cartridge before its intended use.

## Distribution

Worldwide - US Nationwide distribution in the states of AR, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, MN, MO, NC, NE, NJ, NV, NY, OH, PA, SC, TN, TX, VA, WA and the country of Canada.

## Key facts

- **Recall number:** Z-1104-2025
- **Recalling firm:** New Medical Technologies Gmbh
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-12-19
- **Report date:** 2025-02-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bern, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1104-2025

## Citation

> AI Analytics. FDA recall Z-1104-2025. Retrieved 2026-08-11 from https://api.ai-analytics.org/recall/Z-1104-2025. Source: US FDA. Licensed CC0.

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