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U.S. Department of Health and Human Services

Class 2 Device Recall ActCel Topical Hemostatic Dressing

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  Class 2 Device Recall ActCel Topical Hemostatic Dressing see related information
Date Initiated by Firm May 18, 2015
Date Posted May 30, 2015
Recall Status1 Terminated 3 on August 26, 2015
Recall Number Z-1697-2015
Recall Event ID 71279
510(K)Number K112800  
Product Classification Dressing, wound, drug - Product Code FRO
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.
Code Information 201303054, 201310418, 201406259, 201409367, 201502051, 201307297, 201310460, 201401023, 201406260, 201409368, 201303054, 201305137, 201401022, 201403096, 201404143
Recalling Firm/
Manufacturer		 Coreva Health Science LLC
2985 E Hillcrest Dr Ste 205
Westlake Village CA 91362-3179
For Additional Information Contact
818-865-0951
Manufacturer 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.
FDA Determined
Cause 2		 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 statement; and - Complete the attached Medical Device Labeling Clarification Return Response form and return it to Coreva Health Science. The firm states to direct any questions to: Ms. Casssie Inglis, Vice President of Marketing. email: cassie@coreva.net phone: 818-685-0951 ext. 119 toll free: 800-808-9094 ext. 119 Monday through Friday, 9am-4pm PST
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FRO and Original Applicant = HUIZHOU FORYOU MEDICAL DEVICES CO, LTD
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