Class 2 Device Recall Procedure Kits

• Date Initiated by Firm: September 23, 2016
• Date Posted: November 19, 2016
• Recall Status: Terminated on March 27, 2017
• Recall Number: Z-0632-2017
• Recall Event ID: 75367
• Product Classification: Single use instrument tray - Product Code OJV
• Product: Manifold Kit. Catalog Number K09-11867AP
• Code Information: Lot Number: H996495
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 W Merit Pkwy; South Jordan UT 84095-2416
• For Additional Information Contact: Ileana Davis; 801-253-1600
• Manufacturer Reason for Recall: Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.
• FDA Determined Cause: Process control
• Action: Consignees notified via letter on 09/23/16 to quarantine any devices and discontinue use, ensure all personnel to whom the devices were distributed are made aware of the field action, and return affected devices to Merit Medical.
• Quantity in Commerce: 40 units
• Distribution: Nationwide to VA, UT, and NC. Other foreign consignee Japan. No Canadian and VA/govt/military consignees.
• 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.