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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 FirmJuly 20, 2004
Date PostedAugust 04, 2004
Recall Status1 Terminated 3 on January 21, 2005
Recall NumberZ-1311-04
Recall Event ID 29651
510(K)NumberK031691 
Product Classification Dilator, Vessel, For Percutaneous Catheterization - Product Code DRE
ProductMerit MAK Mini Access Kit, 4 French (1.3mm)
Code Information Catalog Number MAK405, Lot Numbers:G338462, M9337638, MR314387, MR317165, MR320060.
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 2		Other
ActionConsignees were notified by phone and letter on 7/20/2004.
Quantity in Commerce634 kits
DistributionNationwide, 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 CycleTPLC 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) Database510(K)s with Product Code = DRE
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