Inter-Med LLC recalls Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Advance Aluminum Chloride Gel Clear Hemostatic Gel Kit, Catalog number 504600-28
Lot / code information
- Model
- 504600-28
- UDI
- 00371347008104
- Lot #
- 2026-0204
What the firm is doing
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.
DistributionShow detailsHide
US Nationwide distribution in the states of Tennessee and Missouri.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2400-2026
- FDA 510(k) clearance · K190220The device's official FDA premarket clearance record
- FDA device classification · MVLOfficial FDA classification for this device type
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Inter-Med LlcSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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