Recall Z-1697-2015— Coreva Health Science LLC

Name: FDA recall Z-1697-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-18

Class II · Terminated

Class II FDA medical device recall by Coreva Health Science LLC, initiated 2015-05-18, terminated 2015-08-26. It names one FDA 510(k) clearance: K112800. 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..

Recalling firm: Coreva Health Science LLC
Classification: Class II
Status: Terminated
Initiated: 2015-05-18
Terminated: 2015-08-26
Firm location: Westlake Village, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K112800 — SUNTOUCH TOPICAL HEMOSTATIC DRESSINGHuizhou Foryou Medical Devices Co., Ltd.·cleared 2012-05-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.