# FDA recall Z-3300-2024

> **Dr Franz Koehler Chemie Gmbh** · Class II · device recall initiated 2024-01-09.

## Product

Custodiol HTK Solution, 500ml bottle. 10 per carton.

## Reason for recall

Potential for particles to be present in solution.

## Distribution

US Nationwide distribution in the state of North Carolina.

## Key facts

- **Recall number:** Z-3300-2024
- **Recalling firm:** Dr Franz Koehler Chemie Gmbh
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-01-09
- **Report date:** 2024-10-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bensheim, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3300-2024

## Citation

> AI Analytics. FDA recall Z-3300-2024. Retrieved 2026-06-14 from https://api.ai-analytics.org/recall/Z-3300-2024. Source: US FDA. Licensed CC0.

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