FDA Enforcement
Class II
Ongoing
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Recall: Z-2400-2026
·
Reported June 17, 2026
Enforcement
- Recall Number
- Z-2400-2026
- Event ID
- 99105
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Inter-Med Llc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- N/A
- Report Date
- June 17, 2026
- Initiation Date
- May 27, 2026
- Classification Date
- June 10, 2026
- Address
- 2200 South St, N/A, Racine, WI, 53404-1510, United States
Description
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Reason
Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. 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.
Code Info
Model No. 504600-28; UDI-DI 00371347008104; Lot Number 2026-0204
Distribution
US Nationwide distribution in the states of Tennessee and Missouri.
Quantity
500