Z-0137-2013 Class II Terminated
FDA device recall Z-0137-2013 was initiated by Nipro Medical Corporation on Jul 27, 2012 and is designated Class II. 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… The recall status is terminated (terminated May 25, 2013). Affected quantity: 300.
Recall details
- Product Type
- Devices
- Report Date
- Oct 31, 2012
- Initiation Date
- Jul 27, 2012
- Termination Date
- May 25, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 300
Product description
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.
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+60000003 Lot #: 11F20, 11I27, 12B10
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0137-2013
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026