Aluminum chloride hemostatic gel kits shipped with wrong package insert
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kits are being recalled because some units contain the package insert for Ferric Sulfate Gel, which gives different first aid instructions.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall where the enclosed insert gives first aid instructions that directly contradict the correct ones, a risk of harm with no injuries reported.
Plain-English summary
The Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, catalog number 504600-28, from Inter-Med LLC, is being recalled. The action covers 500 units in lot 2026-0204, UDI-DI 00371347008104.
Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. According to the manufacturer, the incorrect insert misidentifies the product and contains different first aid instructions, most critically in that the Ferric Sulfate insert instructs users to induce vomiting in the case of ingestion while the correct Aluminum Chloride insert instructs users not to induce vomiting. The FDA classified the action as Class II.
Distribution was within the United States, in Tennessee and Missouri. The kits are supplied to dental and healthcare practices rather than sold to consumers.
Practices should identify affected stock using the catalog number, UDI-DI and lot number above and follow the instructions issued by Inter-Med.
The recalled product
- Product
- Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
- Manufacturer
- Inter-Med Llc
- Affected units
- 500
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Model No. 504600-28
- UDI-DI 00371347008104
- Lot Number 2026-0204
Distribution
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