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U.S. Department of Health and Human Services

Class 2 Device Recall Merit Maestro Microcatheter

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  Class 2 Device Recall Merit Maestro Microcatheter see related information
Date Initiated by Firm September 26, 2014
Date Posted October 31, 2014
Recall Status1 Terminated 3 on November 19, 2014
Recall Number Z-0162-2015
Recall Event ID 69452
510(K)Number K082613  
Product Classification Catheter, continuous flush - Product Code KRA
Product Merit Maestro Microcatheter, 2.4F 130cm Straight, REF28MC24130ST, Rx Only, Non-pyrogenic Sterile if package is unopened or undamaged.
Code Information Catalog No: 28MC24130ST, Lot H665694, H669824, Exp 2017 and Catalog No: 28MC24150SN, Lot H665696, Exp 7/31/2014
Recalling Firm/
Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan UT 84095
For Additional Information Contact Cory Marsh
Manufacturer Reason
for Recall
These microcatheters were packaged with a 2.8 F distal tip, rather than the labeled 2.4 F.
FDA Determined
Cause 2
Mixed-up of materials/components
Action Consignees were notified via letter on September 26, 2014. Written notification included 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. An email notification was sent to US Merit sales representatives with accounts that had received affected product. The affected sales representatives were provided a Customer Response Form applicable to their account, a representative copy of communications sent directly to their affected accounts, and a copy of the Frequently Asked Questions. Merit sales representatives were instructed to visit the account and assist with the return of the affected units back to the Merit Field Assurance Department.
Quantity in Commerce 56 units
Distribution Nationwide and to India. No govt/military/VA 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 = KRA and Original Applicant = MERIT MEDICAL SYSTEMS, INC.