Class 2 Device Recall Convenience Kit

• Date Initiated by Firm: August 25, 2016
• Create Date: October 03, 2016
• Recall Status: Terminated on December 01, 2016
• Recall Number: Z-0002-2017
• Recall Event ID: 75127
• 510(K)Number: K122321
• Product Classification: Syringe, balloon inflation - Product Code MAV
• Product: Merit Inflation Syringe Kit. Catalog Number KOS-02857
• Code Information: Lot Numbers: H959038, H970334, H984351.
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc.; 1600 W Merit Pkwy; South Jordan UT 84095-2416
• For Additional Information Contact: Cory Marsh; 801-316-3690
• Manufacturer Reason for Recall: Merit Medical Systems, Inc. announces a voluntary field action for Merit Inflation Syring Kit due to unit labels missing required device labeling information.
• FDA Determined Cause: Labeling design
• Action: Merit Medical Inc. notified all affected customers on August 25, 2016, via verbal and written notification to return the affected units. The returned units will be re-labeled. For further questions, please call (801) 316-3690.
• Quantity in Commerce: 1,297 total units
• Distribution: One consignee located in CA. No Canadian, other foreign or 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.

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