Class 2 Device Recall LEGGINGS W/7" CUFF 30" x 42"

• Date Initiated by Firm: July 10, 2015
• Date Posted: September 03, 2015
• Recall Status: Terminated on April 12, 2017
• Recall Number: Z-2594-2015
• Recall Event ID: 71721
• 510(K)Number: K902886
• Product Classification: Gown, surgical - Product Code FYA
• Product: LEGGINGS W/7" CUFF 30" x 42" 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
• Code Information: Code:9001574 Lots: 141015808 exp. 3/31/16 150418239 exp. 5/31/16 150518597 exp. 5/31/16 150518597 exp. 5/31/16
• Recalling Firm/ Manufacturer: Customed, Inc; Calle Igualdad Final #7; Fajardo PR 00738
• Manufacturer Reason for Recall: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
• FDA Determined Cause: Packaging
• Action: Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer.
• Quantity in Commerce: 300
• Distribution: Distributed Only in Puerto Rico.
• 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.

• 510(K) Database: 510(K)s with Product Code = FYA