The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2696-2014·Announced 2014-10-01

Argon UltraStream Hemodialysis Catheters Recalled for Luer Cracking Risk

Argon Medical Devices is recalling UltraStream Chronic Hemodialysis Catheters because cracks may develop on the red arterial luer during use.

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 that poses a risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

Argon Medical Devices, Inc. is recalling the UltraStream Chronic Hemodialysis Catheter Standard Kit. The recall covers model numbers 32101524, 32101528, 32101532, 32101536, and 32102540. A total of 3,783 units were distributed nationwide.

The recall was initiated because the catheters may develop cracks on the red (arterial) luer during attachment or manipulation. This defect is classified as an FDA Class II recall.

Healthcare facilities and consumers should stop using the affected catheters and contact Argon Medical Devices for instructions on return or replacement.

The recalled product

Product
UltraStream Chronic Hemodialysis Catheter Standard Kit; Model Number 32101524 (24 cm), 32101528 (28cm), 32101532 (32 cm), and 32101536 (36 cm) and 32102540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high…
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: 11034387
  • 11034915
  • 11039525
  • 11045439
  • 11057890
  • 11059625
  • 11027376
  • 11034000
  • 11035976
  • 11036453
  • 11038334
  • 11041518
  • 11044383
  • 11047511
  • 11049668
  • 11052111
  • 11054546
  • 11059459
  • 11060050
  • 11033757

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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