Hemodialysis vascular access kit recalled for loose metal shavings
Angiodynamics recalls 455 DURAFLOW 2 hemodialysis kits for loose metal shavings that could embolize, potentially requiring surgical removal.
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: FDA Class II recall for a manufacturing defect that could cause serious harm (metal embolization potentially requiring surgery), but with no reported illnesses or injuries. Meets criteria for risk-of-harm product without reported harm.
Plain-English summary
Angiodynamics, Inc. is recalling 455 units of DURAFLOW 2, 24CM STRAIGHT BASIC KIT (lot numbers 5807192 and 5807197, UDI-DI: 25051684014738). This device is used to establish long-term vascular access for hemodialysis and apheresis procedures.
The Tri-Ball Tunneler component of the device may contain loosely affixed metal shavings. There is a potential for these metal shavings to embolize, which means they could enter the bloodstream and travel through blood vessels. If this occurs, surgical intervention may be necessary to remove the material.
The 455 recalled units were distributed in Virginia. This is a Class II recall from the FDA.
The recalled product
- Product
- DURAFLOW 2, 24CM STRAIGHT BASIC KIT -Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012015
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- Affected units
- 455
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 (2)
- UDI-DI: 25051684014738 Lot Numbers: 5807192
- 5807197
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 15 recalled by Angiodynamics, 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.
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