FDA Medical Device Recalls (openFDA)
Inter-Med Llc: Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
- Recall number
- Z-2400-2026
- Recalling firm
- Inter-Med Llc
- Product
- Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
- Status
- Open, Classified
- Initiated
- 2026-05-27
- Posted
- 2026-06-10
- Terminated
- not on file
- 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.
- 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
- 500
- Distribution
- US Nationwide distribution in the states of Tennessee and Missouri.
- Lot, serial or model codes
- Model No. 504600-28; UDI-DI 00371347008104; Lot Number 2026-0204
- 510(k) numbers
- ["K190220"]
- PMA numbers
- not on file
- Product code
- MVL
- Firm FEI
- 3000209941
- Firm city
- Racine
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28