Duraflow 2 vascular catheter kit recalled for loose metal shavings
Angiodynamics Inc. is recalling DURAFLOW 2 vascular catheter kits used for hemodialysis and apheresis access due to potential metal shavings that may detach and travel through the vascular system, 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: This is a Class II medical device recall with potential for metal fragment embolization requiring possible surgical intervention. No illnesses or injuries are reported in the source material. Per the severity rubric, risk-of-harm products where injury has not yet been reported are rated High (3).
Plain-English summary
DURAFLOW 2 55CM STRAIGHT BASIC KIT PG is a vascular access catheter kit manufactured by Angiodynamics Inc. intended for long-term vascular access in hemodialysis and apheresis procedures. The affected product is from Lot Number 5805171.
The recalled units may contain loosely affixed metal shavings. If these shavings become detached, they could embolize (travel through the bloodstream), potentially requiring surgical removal.
This recall affects 188 units that were distributed in Virginia.
Healthcare facilities and patients who may have received this device should consult with their care team about the appropriate course of action.
The recalled product
- Product
- DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012115
- Manufacturer
- Angiodynamics, Inc.
- Hazard
- Affected units
- 188
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:15051684014786 Lot Numbers: 5805171
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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