Recall Z-0138-2013— Nipro Medical Corporation

Name: FDA recall Z-0138-2013
Creator: U.S. Food and Drug Administration
Published: 2012-07-27

Class II · Terminated

Class II FDA medical device recall by Nipro Medical Corporation, initiated 2012-07-27, terminated 2013-05-25. It names one FDA 510(k) clearance: K001251. Product: AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devices within the vasculature.. Reason: 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..

Recalling firm: Nipro Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2012-07-27
Terminated: 2013-05-25
Firm location: Miami, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K001251 — SNIPER, MODEL OR-3872XX SERIESNipro Medical Corp.·cleared 2000-07-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular. 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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.