Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999LV1, Exu-Dry Large Burn Vest, Smith & Nephew, Inc.,Largo, Florida

Consignees were notified of recall by certified mail, Urgent Device Recall letter dated 11/21/2007, which was sent to each consignee. The recalled product will be returned to the firm by pre-paid FedEX return labels. A second letter is to be issued to each distributor for recall to the retail level, as the firm's original recall strategy of distributor level recall, was deemed inappropriate by CDRH