Z-0137-2013Class II

AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner Hydrophilic Guidewire is designed...

Name: Z-0137-2013 AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner Hydrophilic Guidewire is designed...
Creator: Nipro Medical Corporation
Published: 2012-07-27
License: https://open.fda.gov/license/

Nipro Medical Corporation / initiated 2012-07-27 / Terminated / root cause: manufacturing process

FDA source

Nipro Medical Corporation began a recall of AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff. AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/... on 2012-07-27. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0137-2013
Classification: Class II
Status: Terminated
Initiated: 2012-07-27
Posted: 2012-10-25
Terminated: 2013-05-25
Recalling firm: Nipro Medical Corporation
Product: 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.
Product code: DQX Wire, Guide, Catheter
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.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Nipro Medical Corp. sent notifications to their consignee via e-mail and fax on July 27, 2012 and September 13, 2012 to their affected customer. The letters identified the product, problem, and actions to be taken by the customer. The letter instructs the customer to place all affected product in stock on hold. A Aqualiner-Recall Response form was attached for the customer to complete and return. Contact the firm at 305-599-7174 ext. 249 for questions regarding this notice.
Quantity in commerce: 300
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.
Product codes and lots: Item Code: AL+60000003 Lot #: 11F20, 11I27, 12B10

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0137-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0134-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25
Z-0135-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25
Z-0136-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25
Z-0137-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25
Z-0138-2013	Class II	Terminated	Voluntary: Firm initiated	2012-10-31	2012-10-25

Product code DQX

K001251Class IISniper, Model or-3872Xx SeriesNipro Medical Corp. / cleared 2000-07-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)