Recall Z-1697-2015 ยท FRO Dressing, Wound, Drug
Coreva Health Science LLC
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.
| Date | May 30, 2015 (initiated May 18, 2015) |
| Status | Terminated |
| 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. |
| Root cause | Labeling False and Misleading |
| Action | On 05/18/15 the firm sent out customer notification letters to those distributors that were identified as marketing ActCel Hemostatic Dressing for use to help control bleeding from open wounds in body cavities. The firm's notification letter provided the following actions to be taken by the customer: - Review their literature and labeling (including internet websites) to determine whether there are any marketing statements for usage in body cavities; -Destroy all hardcopy literature and labeling with the statement for usage in body cavities - Correct all Internet websites eliminating his stat |
| Quantity | 180,900 |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112800 | SUNTOUCH TOPICAL HEMOSTATIC DRESSING Huizhou Foryou Medical Devices Co., Ltd., May 23, 2012 |