International Medical Devices Database

Manufacturer Address
Coreva Health Science LLC, 2985 E Hillcrest Dr Ste 205, Westlake Village CA 91362-3179
Manufacturer Parent Company (2017)
Coreva Health Science Llc
Source
USFDA
1 Event
- Recall of Device Recall ActCel Topical Hemostatic Dressing

One device in the database

Device Recall ActCel Topical Hemostatic Dressing

Model / Serial
201303054, 201310418, 201406259, 201409367, 201502051, 201307297, 201310460, 201401023, 201406260, 201409368, 201303054, 201305137, 201401022, 201403096, 201404143
Product Classification
General and Plastic Surgery Devices
Device Class
Unclassified
Implanted device?
No
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.
Product Description
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.

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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Coreva Health Science LLC

One device in the database

Device Recall ActCel Topical Hemostatic Dressing