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Class 2 Device Recall Dilator for percutaneous catheterization. |
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Date Initiated by Firm |
July 20, 2004 |
Date Posted |
August 04, 2004 |
Recall Status1 |
Terminated 3 on January 21, 2005 |
Recall Number |
Z-1309-04 |
Recall Event ID |
29651 |
510(K)Number |
K031691
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Product Classification |
Dilator, Vessel, For Percutaneous Catheterization - Product Code DRE
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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
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For Additional Information Contact |
801-253-1600
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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.
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FDA Determined Cause 2 |
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
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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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510(K) Database |
510(K)s with Product Code = DRE and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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