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Recall Observatory FDA recall evidence

Device product

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

Z-2400-2026

May 27, 2026

Class II

Product summary

Firm
Inter-Med Llc
Event
Event 99105
Status
Ongoing
Classification
Class II
Quantity
500
Official record key
device-enforcement:Z-2400-2026

Official wording

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 information: Model No. 504600-28; UDI-DI 00371347008104; Lot Number 2026-0204

Distribution pattern: US Nationwide distribution in the states of Tennessee and Missouri.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.