FDA DeviceClass IINotable

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

Date: 2026-06-17
Brand: Inter-Med Llc
Category: Medical Device
FDA Class: Class II

Description

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.

Hazard

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.

Remedy

500

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