FDA Device recall Z-1697-2015
ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble Regenerated Cellulose…
- FDA Device
- Class II
- terminated
- Published 2015-06-10
On 2015-06-10 the FDA classified a Class II recall of ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble Regenerated Cellulose… by Coreva Health Science, citing 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 bo….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1697-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-05-18 |
| Published | 2015-06-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Coreva Health Science |
| Distribution | AZ, FL, NY, TX, VA, WA |
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.
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.
Identifiers
| code_info | 201303054, 201310418, 201406259, 201409367, 201502051, 201307297, 201310460, 201401023, 201406260, 201409368, 201303054…201303054, 201310418, 201406259, 201409367, 201502051, 201307297, 201310460, 201401023, 201406260, 201409368, 201303054, 201305137, 201401022, 201403096, 201404143 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1697-2015%22
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