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U.S. Department of Health and Human Services

Class 2 Device Recall Merit Laureate Hydrophilic Guide Wire

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  Class 2 Device Recall Merit Laureate Hydrophilic Guide Wire see related information
Date Initiated by Firm April 14, 2014
Date Posted April 22, 2014
Recall Status1 Terminated 3 on July 17, 2014
Recall Number Z-1485-2014
Recall Event ID 68041
510(K)Number K120644  
Product Classification catheter guide wire - Product Code DQX
Product Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102").
Code Information Lot No. K556399, Expires 2016-10
Recalling Firm/
Manufacturer		 Merit Medical Systems, Inc.
1600 West Merit Parkway
South Jordan UT 84095
For Additional Information Contact Vicki Godwin
801-208-4160
Manufacturer Reason
for Recall		 Discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, which has a straight tip and a stiff shaft. This lot was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA35260EX, which has an angled tip, standard shaft and Chinese unit labeling.
FDA Determined
Cause 2		 Process control
Action Customers were notified on 4/14/14 via certified letter with instructions to identify product, discontinue use, and return products.
Quantity in Commerce 173
Distribution Worldwide Distribution: USA Nationwide and China. No military/govt/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 = DQX and Original Applicant = MERIT MEDICAL SYSTEMS, INC.
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