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
201303054201310418201406259201409367201502051201307297201310460201401023201406260201409368201303054201305137201401022201403096201404143
- 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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