FDA Medical Device Recalls (openFDA)
Smith And Nephew, Inc. Wound Management Division: Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999BP1, Exu-Dry Adult Buttocks Dressing, Smith & Nephew, Inc.,Largo, Florida.
- Recall number
- Z-1207-2008
- Recalling firm
- Smith And Nephew, Inc. Wound Management Division
- Product
- Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999BP1, Exu-Dry Adult Buttocks Dressing, Smith & Nephew, Inc.,Largo, Florida.
- Status
- Terminated
- Initiated
- 2007-11-21
- Posted
- 2008-03-12
- Terminated
- 2008-12-15
- 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
- 350 Dressings
- Distribution
- Worldwide-USA, England, Japan, South Africa, New Zealand, Australia and Canada.
- Lot, serial or model codes
- Lot Numbers: 70607, 70506, and 70629.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MCY
- Firm FEI
- 3006760724
- Firm city
- Largo
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28