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U.S. Department of Health and Human Services

Class 2 Device Recall AquaLiner Hydrophilic Guidewire

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 Class 2 Recall
AquaLiner Hydrophilic Guidewire
see related information
Date Posted October 25, 2012
Recall Status1 Terminated on May 25, 2013
Recall Number Z-0137-2013
Recall Event ID 63302
Premarket Notification
510(K) Number
K001251 
Product Classification Wire, Guide, Catheter - Product Code DQX
Product AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. 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+60000003 Lot #: 11F20, 11I27, 12B10
Recalling Firm/
Manufacturer
Nipro Medical Corporation
3150 Nw 107th Ave
Miami, Florida 33172
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
PRODUCTION CONTROLS: 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 300
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

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = DQX and Original Applicant = NIPRO MEDICAL CORP.
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