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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
AquaLiner Hydrophilic Guidewire 		see related information
Date Posted October 25, 2012
Recall Number Z-0135-2013
Product AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ 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+60000103 Lot #: 11E27, 11F27, 11H22, 11I19, 11J24, 12B03, 12B09, 12D09
Recalling Firm/
Manufacturer		 Nipro Medical Corporation
3150 Nw 107th Ave
Miami, Florida 33172
For Additional Information Contact Jessica Oswald-McLeod
305-599-7174
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.
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 1500
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.
 
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