Devices

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.
Manufacturer
Coreva Health Science LLC
1 Event
- Recall of Device Recall ActCel Topical Hemostatic Dressing

Manufacturer

Coreva Health Science LLC

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

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