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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-1486-2014
Recall Event ID 68041
510(K)Number K120644  
Product Classification catheter guide wire - Product Code DQX
Product Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102").
Code Information Lot No. K556402, 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		 Merit Medical Systems, Inc. is voluntarily conducting a recall due to a discrepancy between the carton and unit labeling for the Merit Laureate Hydrophilic 0.035" 260 cm Guide Wire, catalog number LWSTFS35260EX, lot number K556399 (173 units), which has a straight tip and a stiff shaft. Lot K556399 was partially mixed with another lot of Laureate 0.035" 260 cm Guide Wire, catalog number LWSTDA3
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 186
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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