Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Summary
The FDA issued a Class II for Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-2 by Inter-Med Llc. Reason: Some units of Aluminum Chloride Gel contain the package insert for Ferric Sulfate Gel. The incorrect insert misidentifies the product and contains dif.
Details
Source
Device Recall
External ID
Z-2400-2026
Action Date
2026-06-17
Status
Ongoing
Category
device
Product Description
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Lot/Code Info: Model No. 504600-28; UDI-DI 00371347008104; Lot Number 2026-0204
Quantity Affected: 500
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.
Distribution
US Nationwide distribution in the states of Tennessee and Missouri.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-05-27
Company
Racine, WI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 228 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Inter-Med Llc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Inter-Med Llc have FDA actions?
This is the only FDA action we have on record for Inter-Med Llc in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2400-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
Want to know the moment something like this happens?
Get alerts for deviceRelated Actions
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 24 cm, Straight Extensions, IC Tray REF: 888810200
Covidien LP · 2023-08-23
Sterile Procedural Trays, labeled as the following: a. BREAST AUGMENTATION b. BREAST REDUCTION CDS c. CUH ABDOMINO
MEDLINE INDUSTRIES, LP - Northfield · 2023-02-15
VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the uri
Boston Scientific Corporation · 2024-09-25
EnChroma Safety Glasses with Rx Indoor Universal Lenses: Martinez Cx1 Indoor Rx, SKU: Cx.PC.IN.MTZ.BK.Rx; Summit Indoo
Enchroma Inc · 2024-11-27
Otological Ventilation Tube - T-Tube 9mm - Silicone; Product Code: NZ3309;
Adept Medical Ltd · 2025-01-29