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
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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
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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 |
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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 = DQX
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