Coreva Recalls ActCel Hemostatic Dressing for Unapproved Marketing Claims
Coreva Health Science is recalling ActCel Hemostatic Dressing because customer literature and websites promoted unapproved uses for controlling bleeding in body cavities.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the hazard is limited to unapproved marketing claims (mis-labeling/promotion) without reported injuries or illnesses, fitting the 'Moderate' criteria for labeling errors.
Plain-English summary
Coreva Health Science, LLC. is recalling ActCel Hemostatic Dressing, a prescription device indicated for the management of topical wounds and temporary control of external surface bleeding. The recall was initiated because customer literature and websites promoted the product as capable of helping control bleeding from open wounds and in body cavities, which is not an approved indication.
The recall involves 180,900 units of the product. Distribution was limited to the United States, specifically to consignees in Texas, New York, Florida, Virginia, Washington, and Arizona. The firm noted that the distribution list targets specific distributors observed using the unapproved marketing claims rather than all potential purchasers.
Consumers and healthcare providers should stop using the product and contact Coreva Health Science, LLC. for further instructions or a refund. The product is a topical hemostatic dressing made of soluble regenerated cellulose, intended for external topical and temporary use only.
The recalled product
- 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 d
- Manufacturer
- Coreva Health Science LLC
- Affected units
- 180,900
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 201303054
- 201310418
- 201406259
- 201409367
- 201502051
- 201307297
- 201310460
- 201401023
- 201406260
- 201409368
- 201305137
- 201401022
- 201403096
- 201404143
Distribution
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