Z-2400-2026Class II

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

Name: Z-2400-2026 Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Creator: Inter-Med Llc
Published: 2026-05-27
License: https://open.fda.gov/license/

Inter-Med, Inc. / initiated 2026-05-27 / Open, Classified / root cause: labeling and UDI

FDA source

Inter-Med Llc began a recall of Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28 on 2026-05-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2400-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-05-27
Posted: 2026-06-10
Recalling firm: Inter-Med, Inc.
Product: Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Product code: MVL Cord, Retraction
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On 5/27/2026, firm notified consignees via email. Consignees were instructed to return all units from Lot 2026-0204 to Inter-Med, Inc. Inter-Med, Inc. will provide prepaid return shipping labels. All returned product will be replaced with correctly packaged product at no charge, or a credit may be issued at the customer's preference. Customers must also notify any downstream dental practices or end users who received product from this lot and instruct them to return product.
Quantity in commerce: 500
Distribution: US Nationwide distribution in the states of Tennessee and Missouri.
Product codes and lots: Model No. 504600-28; UDI-DI 00371347008104; Lot Number 2026-0204

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2400-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2400-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-17	2026-06-10

Product code MVL

K190220UnclassifiedVista FS, Vista FS LiquidInter-Med/Vista Dental Products / cleared 2019-06-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)