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U.S. Department of Health and Human Services

Class 2 Device Recall Convenience Kit

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  Class 2 Device Recall Convenience Kit see related information
Date Initiated by Firm August 25, 2016
Create Date October 03, 2016
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = MERIT MEDICAL IRELAND, LTD.
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