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U.S. Department of Health and Human Services

Class 2 Device Recall Merit Custom Syringe Kit

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  Class 2 Device Recall Merit Custom Syringe Kit see related information
Date Initiated by Firm March 13, 2014
Date Posted April 03, 2014
Recall Status1 Terminated 3 on July 07, 2014
Recall Number Z-1320-2014
Recall Event ID 67844
510(K)Number K875196  
Product Classification Syringe, piston - Product Code FMF
Product Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.
Code Information Lot Number H574228
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan UT 84095
For Additional Information Contact Paul Kennedy
801-208-4301
Manufacturer Reason
for Recall		 The products are labeled as sterile but were not sterilized.
FDA Determined
Cause 2		 Release of Material/Component prior to receiving test results
Action Merit Medical sent an Urgent Product Recall Notice dated March 14, 2014 to all customers and sales representatives via email. The letter identified the affected product, problem and actions to be taken. Customers were provided a Product Retrieval Form, product identification information, instruction to immediately quarantine any devices and discontinue use, ensure all personnel to whom devices were distributed are made aware of this field action, and instructions to contact their Merit representative to arrange product return and replacement. For questions call 1-801-316-4822.
Quantity in Commerce 15
Distribution Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.
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 = FMF and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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