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U.S. Department of Health and Human Services

Class 2 Device Recall Dilator for percutaneous catheterization.

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  Class 2 Device Recall Dilator for percutaneous catheterization. see related information
Date Initiated by Firm July 20, 2004
Date Posted August 04, 2004
Recall Status1 Terminated 3 on January 21, 2005
Recall Number Z-1311-04
Recall Event ID 29651
510(K)Number K031691  
Product Classification Dilator, Vessel, For Percutaneous Catheterization - Product Code DRE
Product Merit MAK Mini Access Kit, 4 French (1.3mm)
Code Information Catalog Number MAK405, Lot Numbers:G338462, M9337638, MR314387, MR317165, MR320060.
Recalling Firm/
Merit Medical Systems, Inc
1600 Merit Pkwy
South Jordan UT 84095-2416
For Additional Information Contact
Manufacturer Reason
for Recall
Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt.
FDA Determined
Cause 2
Action Consignees were notified by phone and letter on 7/20/2004.
Quantity in Commerce 634 kits
Distribution Nationwide, including VA facilities in MA, MI, NY, RI and TX. Argentina, Canada, China, Germany, Italy, Israel, Netherlands, New Zealand, Saudi Arabia, Scotland, Singapore, Thailand, United Arab Emirates.
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 = DRE and Original Applicant = MERIT MEDICAL SYSTEMS, INC.