FDAClass IIOctober 31, 2012

AquaLiner Hydrophilic Guidewire 0.035" X 260cm recall

AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to…

Why was AquaLiner Hydrophilic Guidewire 0.035" X 260cm recalled?

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 should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Item Code: AL+60000203 Lot #: 11G02

Product
AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to…
Recalling firm
Nipro Medical Corporation
Quantity
100
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.
Recall date
October 31, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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