Class 3 Device Recall Episeal wound closure strips

• Date Initiated by Firm: February 07, 2012
• Date Posted: April 17, 2012
• Recall Status: Terminated on July 10, 2013
• Recall Number: Z-1423-2012
• Recall Event ID: 61403
• Product Classification: Tape and bandage, adhesive - Product Code KGX
• Product: Non-sterile wound closure strips, packaged as follows: DeRoyal NS EPISEAL, Wound Closure Strips, REF 46-202N, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal NS EPISEAL, Wound Closure Strips, REF 46-204N, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849 DeRoyal NS EPISEAL, Wound Closure Strips, REF 46-214N, Distributed by: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849; Manufacturer: DeRoyal Industries, 200 DeBusk Lane, Powell TN 37849
• Code Information: REF 46-202N, Lot Numbers: 26835591 and 25191755; REF 46-204N, Lot Numbers: 28084357, 28075961, 27003412, 27749425, 27392690, 26036749, 25731731, and 25235543; REF 46-214N, Lot Numbers: 27507573, 27437325, 26970419, 26970275, 26641033, 26394853, 26094578, 26009222, 25621209, 25235800, 25241960, 25120957, 25068811
• Recalling Firm/ Manufacturer: Deroyal Industries, Inc. Lafollette; 1501 East Central Ave; La Follette TN 37766-2892
• For Additional Information Contact: Tracy Edmundson; 865-362-2334
• Manufacturer Reason for Recall: Packages of Episeal wound closure strips and surgical kits containing them were recalled because the adhesive backing on Episeal wound closure strips may not release from the backing rendering the product unusable.
• FDA Determined Cause: Nonconforming Material/Component
• Action: DeRoyal Industries sent a Recall of Episeal Wound Closure Strip letter dated February 7, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to take the following action: 1. Please identify and quarantine any affected inventory using the product and lot numbers listed above. 2. Render affected product unusable, destroy and discard according to your facilitys guidelines. 3. If you are a distributor, forward this recall to any of your end users that may have affected product or provide us with the list and we will contact them. 4. Please complete the enclosed Notice of Destruction form, indicating the affected products you found in your inventory and destroyed. PLEASE COMPLETE AND RETURN THIS FORM EVEN IF YOU NO LONGER HAVE THE PRODUCT IN INVENTORY. Return this form by fax (865-362-3716) or email (recalls@deroyal.com) within two weeks of the date of this letter. DeRoyal will use your response on the Notice of Destruction form to send replacements as soon as they become available. If you have questions or need assistance with the recall, please contact DeRoyal Customer Support at 1-800-251-9864. We apologize for inconvenience this may cause you
• Quantity in Commerce: 36000 units
• Distribution: Worldwide Distribution -- USA (nationwide)
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.