Summary
The FDA issued a Class II for Custodiol HTK Solution, 500ml bottle. 10 per carton. by Dr Franz Koehler Chemie Gmbh. Reason: Potential for particles to be present in solution..
Details
Source
Device Recall
External ID
Z-3300-2024
Action Date
2024-10-02
Status
Ongoing
Category
device
Product Description
Custodiol HTK Solution, 500ml bottle. 10 per carton.
Lot/Code Info: UDI-DI: 04033133105003, Batch Numbers: 2314212, 2320012, 2322812, 2333512 (all batches)
Quantity Affected: 48 cartons (480 bottles)
Reason for Recall
Potential for particles to be present in solution.
Distribution
US Nationwide distribution in the state of North Carolina.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-09
Company
Bensheim
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 244 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Dr Franz Koehler Chemie Gmbh) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Dr Franz Koehler Chemie Gmbh have FDA actions?
This is the only FDA action we have on record for Dr Franz Koehler Chemie Gmbh in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3300-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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