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U.S. Department of Health and Human Services

Class 2 Device Recall Procedure Kits

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  Class 2 Device Recall Procedure Kits see related information
Date Initiated by Firm September 23, 2016
Date Posted November 19, 2016
Recall Status1 Terminated 3 on March 27, 2017
Recall Number Z-0634-2017
Recall Event ID 75367
Product Classification Single use instrument tray - Product Code OJV
Product Pressure Monitoring Kit (MeriTrans"). Catalog Number K11-00232G
Code Information Lot Number: H996490
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 2		 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 130 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.
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