FDA Recall Open, Classified

DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)

Recall: Z-2305-2026 · Initiated May 18, 2026

Recall

Recall Number
Z-2305-2026
Event Number
99044
Firm
DeRoyal Industries Inc
FEI Number
1043214
Product Code
NAC
Status
Open, Classified
Root Cause
Under Investigation by firm
Initiated
May 18, 2026
Posted
June 3, 2026
Address
200 Debusk Ln, Powell, TN, 37849-4703

Description

DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)

Reason

Sterile wound dressing, lacks sterility assurance

Action

On May 18, 2026, DeRoyal Industries, Inc. issued a Urgent Medical Device Recall Notification to affected consignees via Email. DeRoyal ask consignees to take the following actions 1. identify affected product numbers in your inventory and place in quarantine to prevent further use. Please destroy all product identified 2)If you have questions regarding the recall, please contact Jennifer Marsh at [email protected] or by phone 865-362-6206 or email us at [email protected] 3)PLEASE COMPLETE AND RETURN THE NOTICE OF DESTRUCTION FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. 4)If you distributed this product to other facilities or departments within your institution, it is required by federal law that your customers be notified of this recall. You may either do this directly by forwarding our recall notification and notify us that you have done so, or you may provide us with your customer listing and we will contact them.

Distribution

US Nationwide distribution in the states of FL & NC.

Quantity

800 units