Recall Z-3300-2024— Dr Franz Koehler Chemie Gmbh
Class II · Ongoing
Class II FDA medical device recall by Dr Franz Koehler Chemie Gmbh, initiated 2024-01-09. It names one FDA 510(k) clearance: K192408. Product: Custodiol HTK Solution, 500ml bottle. 10 per carton.. Reason: Potential for particles to be present in solution..
- Recalling firm
- Dr Franz Koehler Chemie Gmbh
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-09
- Firm location
- Bensheim, Germany
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Custodiol HTK Solution, 500ml bottle. 10 per carton.
Reason for recall
Potential for particles to be present in solution.
Data sourced from openFDA. This site is unofficial and independent of the FDA.