Z-0135-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 31, 2012
- Initiation Date
- July 27, 2012
- Termination Date
- May 25, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1500
Product Description
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.
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.
Distribution Pattern
Worldwide Distribution-Distributed in the state of New York and the countries of Spain, Germany, Argentina, Panama, Mexico, Chile, Colombia, Ecuador, Peru, and Brazil.
Code Information
Item Code: AL+60000103 Lot #: 11E27, 11F27, 11H22, 11I19, 11J24, 12B03, 12B09, 12D09