Class 2 Device Recall Dilator for percutaneous catheterization.

• Date Initiated by Firm: July 20, 2004
• Date Posted: August 04, 2004
• Recall Status: Terminated on January 21, 2005
• Recall Number: Z-1309-04
• 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 MAK401, Lot Numbers: G322819, M9337627, MR314384, MR314386, MR317164, MR320056.
• Recalling Firm/ Manufacturer: Merit Medical Systems, Inc; 1600 Merit Pkwy; South Jordan UT 84095-2416
• For Additional Information Contact: 801-253-1600
• 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: Other
• Action: Consignees were notified by phone and letter on 7/20/2004.
• Quantity in Commerce: 1164 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