Z-1203-2008

Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L73, Exu-Dry Sheet 36"x72"...

Name: Z-1203-2008 Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L73, Exu-Dry Sheet 36"x72"...
Creator: Smith And Nephew, Inc. Wound Management Division
Published: 2007-11-21
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2007-11-21 / Terminated / root cause: packaging

FDA source

Smith And Nephew, Inc. Wound Management Division began a recall of Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L73, Exu-Dry Sheet 36"x72" Non-Permeable with Straps, Smith & Nephew, Inc.,Largo, Florida on 2007-11-21. The reason FDA records is "Sterility (package integrity) compromised: Distribution of product that did not meet specifications; open seals". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1203-2008
Status: Terminated
Initiated: 2007-11-21
Posted: 2008-03-12
Terminated: 2008-12-15
Recalling firm: Smith & Nephew, Inc.
Product: Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L73, Exu-Dry Sheet 36"x72" Non-Permeable with Straps, Smith & Nephew, Inc.,Largo, Florida.
Product code: MCY Wound Dressing Kit
Reason for recall: Sterility (package integrity) compromised: Distribution of product that did not meet specifications; open seals.
Root cause tag: packaging
FDA 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 in commerce: 960 Dressings
Distribution: Worldwide-USA, England, Japan, South Africa, New Zealand, Australia and Canada.
Product codes and lots: Lot Numbers: 70703, 70610, and 70509.

Product code MCY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)