Reported Jun 10, 2015 · Terminated

ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble…

Coreva Health Science LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Coreva Health Science LLC · 2985 E Hillcrest Dr Ste 205 · Westlake Village, CA · 91362-3179

Is this the product you have?

  • 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.
Lot codes and dates
    • 201303054
    • 201310418
    • 201406259
    • 201409367
    • 201502051
    • 201307297
    • 201310460
    • 201401023
    • 201406260
    • 201409368
    • 201303054
    • 201305137
    • 201401022
    • 201403096
    • 201404143
Amount recalled
180,900

Where it was sold

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Aug 26, 2015 · Data as of Sep 19, 6:06 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.