Recall Z-2400-2026— Inter-Med Llc
Class II · Ongoing
Class II FDA medical device recall by Inter-Med Llc, initiated 2026-05-27. It names one FDA 510(k) clearance: K190220. Product: Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28. 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..
- Recalling firm
- Inter-Med Llc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-05-27
- Firm location
- Racine, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.