ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble Re

FDA device recall Z-1697-2015 · posted 2015-05-30 · Terminated

Recall details

Recalling firm

Coreva Health Science LLC

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.

Action taken

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

Root cause

Labeling False and Misleading

Status

Terminated

Product code

FRO

Quantity affected

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; rathe

Date initiated

2015-05-18

Date posted

2015-05-30

Date terminated

2015-08-26

Location

Westlake Village, CA

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