The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2697-2014·Announced 2014-10-01

Argon UltraStream Hemodialysis Catheter Recall Due to Luer Cracking

Argon Medical Devices is recalling UltraStream Chronic Hemodialysis Catheters because the red arterial luer may crack during attachment or manipulation.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a structural defect in a medical device where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

Argon Medical Devices, Inc. is recalling the UltraStream Chronic Hemodialysis Catheter, specifically the Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28 cm), 32001532 (32 cm), 32001536 (36 cm), and 32002540 (40 cm). The recall involves 3,783 units that were distributed nationwide.

The recall was initiated because the red (arterial) luer on the catheter may develop cracks during attachment or manipulation. This defect could potentially compromise the integrity of the device during use.

Healthcare providers and patients using these specific model numbers should stop using the affected catheters and contact Argon Medical Devices for further instructions or replacement units. The recall covers specific lot numbers listed in the official FDA documentation.

The recalled product

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…
Manufacturer
Argon Medical Devices, Inc
Category
Medical Device — Hemodialysis Catheter
Hazard
Affected units
3,783

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot Numbers: 11029949
  • 11031335
  • 11033533
  • 11035161
  • 11036607
  • 11037817
  • 11039719
  • 11040058
  • 11042305
  • 11044092
  • 11046743
  • 11048076
  • 11049066
  • 11056427
  • 11059461
  • 11024109
  • 11025359
  • 11027376
  • 11028490
  • 11029950

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Argon Medical Devices, Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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