Device product
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Z-2400-2026
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
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.