FDA recall Z-2400-2026

Inter-Med Llc · Class II · device

Product

Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28

Reason for recall

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.

Distribution

US Nationwide distribution in the states of Tennessee and Missouri.

Key facts

Status
Ongoing
Initiation date
2026-05-27
Report date
2026-06-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Racine, WI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2400-2026