Date Initiated by Firm | July 27, 2012 |
Date Posted | October 25, 2012 |
Recall Status1 |
Terminated 3 on May 25, 2013 |
Recall Number | Z-0138-2013 |
Recall Event ID |
63302 |
510(K)Number | K001251 |
Product Classification |
Wire, guide, catheter - Product Code DQX
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Product | AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular.
AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature. |
Code Information |
Item Code: AL+60000302 Lot #: 12D05 |
Recalling Firm/ Manufacturer |
Nipro Medical Corporation 3150 Nw 107th Ave Miami FL 33172
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For Additional Information Contact | Jessica Oswald-McLeod 305-599-7174 |
Manufacturer Reason for Recall | Nipro Medical Corporation, Miami, FL recalled their AquaLiner Hydrophilic Guidewire because the wires contain insufficient lubricity which causes them to get stuck in the housing and become nonfunctional. |
FDA Determined Cause 2 | Equipment maintenance |
Action | Nipro Medical Corp. sent notifications to their consignee via e-mail and fax on July 27, 2012 and September 13, 2012 to their affected customer. The letters identified the product, problem, and actions to be taken by the customer. The letter instructs the customer to place all affected product in stock on hold. A Aqualiner-Recall Response form was attached for the customer to complete and return. Contact the firm at 305-599-7174 ext. 249 for questions regarding this notice. |
Quantity in Commerce | 700 |
Distribution | Worldwide Distribution-Distributed in the state of New York and the countries of Spain, Germany, Argentina, Panama, Mexico, Chile, Colombia, Ecuador, Peru, and Brazil. |
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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