The Recall Desk
HighFDA (Devices)·Z-1761-2024·Announced 2024-05-15

Vascular access device recalled due to loose metal shavings

DURAFLOW 2 vascular access kits for hemodialysis are being recalled because some units may contain loosely affixed metal shavings that could travel through blood vessels and potentially require surgical removal.

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: This is an FDA Class II recall of a high-risk vascular device where metal shavings pose a risk of serious harm requiring potential surgical intervention. No illnesses or injuries have been reported, fitting the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

Angiodynamics, Inc. is recalling DURAFLOW 2, 28 cm straight basic kits used for long-term vascular access in hemodialysis and apheresis procedures. This recall affects 157 units.

The devices may contain loosely affixed metal shavings. There is potential for these shavings to break free and travel through the bloodstream (embolization), which could require surgical removal.

Patients using this device should consult their healthcare provider. Do not attempt self-removal of the device. Seek immediate medical attention if you experience symptoms that could indicate vascular complications.

The recalled product

Product
DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012021
Manufacturer
Angiodynamics, Inc.
Category
Medical Device — Vascular Access / Hemodialysis
Hazard
  • metal-shavings
  • embolization

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 (1)

  • UDI-DI: 15051684014748 Lot Numbers: 5805837

Distribution

Distributed in 1 state:

  • VA

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