Recall Z-0001-05 ยท MGQ Dressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
DeRoyal Wound Care
Aquasorb Border, Hydrogel Wound Dressing with Polyurethane Film Border, 25 individual packets per case, Catalog # 46-511, 2.5' x 2.5', labeled in part ***Sterile***Manufacturer: DeRoyal 200 Debusk Lane Powell, TN 37849 USA***
| Date | Oct 5, 2004 (initiated Jul 8, 2004) |
| Status | Terminated |
| Reason | Wound dressing failed to meet sterility specifications. |
| Root cause | Other |
| Action | DeRoyal Wound Care put a hold on remaining lot in inventory pending acceptable dose audit results. The recalling firm notified distributors by phone and letter on 7/8/04 and 7/13/04. The notification advised that the product be segregated to prevent further use and that distributors extend the recall to their consignees if product had been distributed. |
| Quantity | 4 cases |
| Distribution | Product was sold to 3 distributors in CA, OH and PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.