Recall Z-2305-2026 ยท NAC Dressing, Wound, Hydrophilic
DeRoyal Industries Inc
DeRoyal Industries Inc. Ref 46-406, Covaderm Plus, Vascular Access Dressing 6"x6" (15cmx15cm)
| Date | Jun 3, 2026 (initiated May 18, 2026) |
| Status | Open, Classified |
| Reason | Sterile wound dressing, lacks sterility assurance |
| Root cause | Under Investigation by firm |
| 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 jmarsh@deroyal.com or by phone 865-362-6206 or email us at recalls@deroyal.com 3)PLEASE COMPLETE AND RETURN THE NOTICE OF DESTRUCTION FORM EVEN IF YOU NO LONGER HAVE ANY INVENTORY. 4)If you dis |
| Quantity | 800 units |
| Distribution | US Nationwide distribution in the states of FL & NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.