Class II — Coreva Health Science LLC
| Recalling firm | COREVA HEALTH SCIENCE, LLC |
|---|---|
| Registered facility | COREVA HEALTH SCIENCE, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Coreva Health Science, LLC. is recalling ActCel Hemostatic Dressing due to customer literature and web sites promoting that it can help control bleeding from open wounds and in body cavities. ActCel is indicated as a prescription device for management of topical wounds and to temporarily control external surface bleeding. |
| Product | ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble Regenerated Cellulose For Bleeding Control For external topical and temporary use only Sterility of contents guaranteed unless individual envelope is damaged or opened. Store at room temperature (41F-104F). Do not autoclave. |
| Quantity | 180,900 |
| Distribution | U.S. distribution to the following; TX, NY, FL, VA, WA, and AZ. No foreign distribution. NOTE: The distribution list the firm provided does not include all consignees that purchased the product; rather target the consignees (distributors) who were observed to be using an unapproved marketing use. |
| Initiated | 2015-05-18 |
| Classified | 2015-05-30 |
| Terminated | 2015-08-26 |
| Recall number | Z-1697-2015 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Coreva Health Science LLC (Z-1697-2015).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/71279/
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