Z-2697-2014Class II

UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36...

Name: Z-2697-2014 UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36...
Creator: Argon Medical Devices, Inc
Published: 2014-06-05
License: https://open.fda.gov/license/

Argon Medical Devices, Inc / initiated 2014-06-05 / Terminated / root cause: design

FDA source

Argon Medical Devices, Inc began a recall of UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm). The Rex Medical... on 2014-06-05. FDA classified it as Class II and gives the reason as "UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2697-2014
Classification: Class II
Status: Terminated
Initiated: 2014-06-05
Posted: 2014-09-24
Terminated: 2015-04-08
Recalling firm: Argon Medical Devices, Inc
Product: UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures.
Product code: MSD Catheter, Hemodialysis, Implanted
Reason for recall: UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.
Root cause tag: design
FDA root cause: Component design/selection
Quantity in commerce: 3,783 units
Distribution: Nationwide Distribution.
Product codes and lots: Lot Numbers: 11029949, 11031335, 11033533, 11035161, 11036607, 11037817, 11039719, 11040058, 11042305, 11044092, 11046743, 11048076, 11049066, 11056427, 11059461, 11024109, 11025359, 11027376, 11028490, 11029950, 11031336, 11034141, 11036893, 11037742, 11038551, 11039237, 11039524, 11039864, 11042306, 11044337, 11048077, 11048786, 11050038, 11054478, 11057548, 11057763, 11059464, 11028491, 11032828, 11034343, 11038165, 11040263, 11042555, 11043587, 11044382, 11047358, 11048923, 11050289, 11054889, 11059622, 11065827, 11035772, 11037651, 11040943, 11059624, 11035771, 11041993, 11050454, 11059467.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2697-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2696-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-24
Z-2697-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-24
Z-2698-2014	Class II	Terminated	Voluntary: Firm initiated	2014-10-01	2014-09-24

Product code MSD

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)