Class 2 Device Recall Customed

• Date Initiated by Firm: January 07, 2016
• Date Posted: April 14, 2016
• Recall Status: Terminated on May 03, 2017
• Recall Number: Z-1492-2016
• Recall Event ID: 72992
• Product Classification: General surgery tray (kit) - Product Code LRO
• Product: Catalog Number: 900946; STRABISMUS SURGICAL PACK; Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
• Code Information: LOT: SL15215 (150719817) 31-JUL-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: Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.
• Quantity in Commerce: 8
• 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.