Hemodialysis Vascular Access Kit Recalled for Loose Metal Shavings
Angiodynamics DURAFLOW 2 hemodialysis kits may contain loosely affixed metal shavings that could enter the bloodstream. Metal fragments may require surgical removal if they embolize.
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: FDA Class II recall with no reported illnesses or injuries. The hazard is theoretical—metal shavings could potentially embolize and require surgical removal—but no cases of harm have been reported. Per the rubric, theoretical risk-of-harm products without reported illness score at most 3 (High).
Plain-English summary
Angiodynamics, Inc. is recalling the DURAFLOW 2, 32CM STRAIGHT BASIC KIT (Product Number H787103012035), a vascular access device indicated for hemodialysis and apheresis. The Tri-Ball Tunneler component may contain loosely affixed metal shavings.
The metal shavings pose a hazard of embolization—they could enter the bloodstream during device insertion or use. If embolization occurs, surgical intervention may be required to remove the metal fragments.
The recall affects 35 units distributed to the Veterans Affairs system. The affected lot number is 5805839 (UDI-DI: 25051684014752).
Healthcare providers who have received these units should cease use immediately and contact Angiodynamics, Inc. for replacement products or further guidance.
The recalled product
- Product
- DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012035
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- metal-shaving
- embolism
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: 25051684014752 Lot Numbers: 5805839
Distribution
Distributed in 1 state:
- VA
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