CLASS II Device recall · Reported 1 Oct 2014 · FDA Enforcement Report

UltraStream Exchange Kit recalled by Argon Medical Devices

Argon Medical Devices is recalling UltraStream Exchange Kit, distributed nationwide in the US. The recall was initiated on 5 Jun 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 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.

Quantity recalled3,783 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2697-2014
FDA event ID: 68521
Recalling firm: Argon Medical Devices, Athens, TX
Classification: Class II
Status: Terminated
Recall initiated: 5 Jun 2014
FDA classified: 24 Sep 2014
Reported: 1 Oct 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Device Malfunction
Device type: Heart & Vascular Devices

Timeline

5 Jun 2014	Recall initiated by company
24 Sep 2014	Classified by FDA	+111 days
1 Oct 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

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.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Is UltraStream Exchange Kit recalled?

Yes. Argon Medical Devices recalled UltraStream Exchange Kit on 5 Jun 2014. The recall is Class II and its status is Terminated. Recall number Z-2697-2014.

Why was it recalled?

UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.

Which lots are affected?

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.

Where was it sold?

Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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