The Recall Desk
HighFDA (Devices)·Z-2698-2014·Announced 2014-10-01

Argon UltraStream Hemodialysis Catheter Recalled for Luer Cracking

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

What this means for you

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. Per the rubric, a Class II recall without reported hospitalizations or injuries falls under the 'High' severity category, representing a risk-of-harm product where injury has not yet been reported.

Plain-English summary

Argon Medical Devices, Inc. is recalling the UltraStream Chronic Hemodialysis Catheter, including the UltraStream Peel Away Kit. The affected model numbers are 32401524 (24 cm), 32401528 (28 cm), 32401532 (32 cm), 32401536 (36 cm), and 32402540 (40 cm). A total of 3,783 units were distributed nationwide.

The recall was initiated because the catheter may develop cracks on the red (arterial) luer during attachment or manipulation. The source text does not report any specific illnesses, injuries, or deaths associated with this defect.

Healthcare providers and consumers should identify the affected units by checking the lot numbers listed in the recall documentation. The source text does not specify a corrective action or contact information for the recalling firm.

The recalled product

Product
UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (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: 11030816
  • 11031844
  • 11032797
  • 11033587
  • 11033816
  • 11034388
  • 11035767
  • 11038234
  • 11038335
  • 11039565
  • 11041289
  • 11041994
  • 11043179
  • 11044967
  • 11045825
  • 11048504
  • 11049437
  • 11049775
  • 11050202
  • 11051294

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 →

Related recalls

Same manufacturer · Argon Medical Devices, Inc

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Same hazard · structural defect

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