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U.S. Department of Health and Human Services

Class 2 Device Recall Customed

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  Class 2 Device Recall Customed see related information
Date Initiated by Firm January 07, 2016
Date Posted April 14, 2016
Recall Status1 Terminated 3 on May 03, 2017
Recall Number Z-1433-2016
Recall Event ID 72992
Product Classification General surgery tray (kit) - Product Code LRO
Product Catalog Number: 900169
Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Code Information LOTS: SL15210 (150719663) 31-JUL-16 SL15244 (150820222) 31-AUG-16   
Recalling Firm/
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 2
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 9
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.