Sterile wound closure strips, packaged as follows: DeRoyal EPISEAL, Wound Closure Strips, REF 46-202, STERILE R, Distrib

FDA device recall Z-1421-2012 · posted 2012-04-17 · Terminated

Recall details

Recalling firm

Deroyal Industries, Inc. Lafollette

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.

Action taken

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

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

KGX

Quantity affected

126,720 units

Distribution

Worldwide Distribution -- USA (nationwide)

Date initiated

2012-02-07

Date posted

2012-04-17

Date terminated

2013-07-10

Location

La Follette, TN