FDA recall Z-3300-2024
Dr Franz Koehler Chemie Gmbh · Class II · device
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
- Status
- Ongoing
- Initiation date
- 2024-01-09
- Report date
- 2024-10-02
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Bensheim, Germany
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3300-2024