Z-1697-2015Class II

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

Name: Z-1697-2015 ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents...
Creator: Coreva Health Science LLC
Published: 2015-05-18
License: https://open.fda.gov/license/

Coreva Health Science LLC / initiated 2015-05-18 / Terminated / root cause: labeling and UDI

FDA source

Coreva Health Science LLC began a recall of ActCel advanced bleeding control Topical Hemostatic Dressing 2in X 2in (5cm X 5cm) 4in X 4in Sterile Contents Soluble Regenerated Cellulose For Bleeding... on 2015-05-18. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1697-2015
Classification: Class II
Status: Terminated
Initiated: 2015-05-18
Posted: 2015-05-30
Terminated: 2015-08-26
Recalling firm: Coreva Health Science LLC
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.
Product code: FRO Dressing, Wound, Drug
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.
Root cause tag: labeling and UDI
FDA 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 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: [email protected] 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.
Product codes and lots: 201303054, 201310418, 201406259, 201409367, 201502051, 201307297, 201310460, 201401023, 201406260, 201409368, 201303054, 201305137, 201401022, 201403096, 201404143

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1697-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1697-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-10	2015-05-30

Product code FRO

K112800UnclassifiedSuntouch Topical Hemostatic DressingHuizhou Foryou Medical Devices Co., Ltd. / cleared 2012-05-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)