FDAFDA · Food and drugs·Recall number Z-0135-2013
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.
Published October 31, 2012 · Recall initiated: July 27, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Nipro Medical Corporation
- Distributor
- Worldwide Distribution-Distributed in the state of New York and the countries of Spain, Germany, Argentina, Panama, Mexico, Chile, Colombia, Ecuador, Peru, and Brazil.
- Lot
- Item Code: AL+60000103 Lot #: 11E27, 11F27, 11H22, 11I19, 11J24, 12B03, 12B09, 12D09
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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