Recall Z-1211-2008 ยท MCY Wound Dressing Kit
Smith And Nephew, Inc. Wound Management Division
Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999M09, Exu-Dry Dressing, 15" x 9", Smith & Nephew, Inc., Largo, Florida.
| Date | Mar 12, 2008 (initiated Nov 21, 2007) |
| Status | Terminated |
| Reason | Sterility (package integrity) compromised: Distribution of product that did not meet specifications; open seals. |
| Root cause | Package design/selection |
| Action | 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 |
| Quantity | 1,410 dressings |
| Distribution | Worldwide-USA, England, Japan, South Africa, New Zealand, Australia and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.