Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number : 5999MJ1, Exu-Dry Medium Burn Jacket, Smith & Nephew,

FDA device recall Z-1205-2008 · posted 2008-03-12 · Terminated

Recall details

Recalling firm

Smith And Nephew, Inc. Wound Management Division

Reason for recall

Sterility (package integrity) compromised: Distribution of product that did not meet specifications; open seals.

Action taken

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

Root cause

Package design/selection

Status

Terminated

Product code

MCY

Quantity affected

170 Dressings

Distribution

Worldwide-USA, England, Japan, South Africa, New Zealand, Australia and Canada.

Date initiated

2007-11-21

Date posted

2008-03-12

Date terminated

2008-12-15

Location

Largo, FL