Vascular Access Catheter Recall Due to Metal Shaving Risk
Angiodynamics is recalling 65 DURAFLOW 2 vascular access devices distributed in Virginia due to potential loose metal shavings that could enter the bloodstream and 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 a Class II recall for a risk-of-harm medical device where injury has not yet been reported. The potential for metal shavings to cause embolism requiring surgical intervention represents a serious but theoretical risk for hemodialysis and apheresis patients.
Plain-English summary
Angiodynamics, Inc. is recalling the DURAFLOW 2, 28cm straight vascular access device (Product Number H787103012195, Lot Number 5807415). This device is intended for long-term vascular access for hemodialysis and apheresis procedures. The recall affects 65 units distributed to healthcare facilities in Virginia.
The devices may contain loosely affixed metal shavings. If these shavings separate and enter the bloodstream, they could cause embolism, which may require surgical removal. The U.S. Food and Drug Administration classified this as a Class II recall.
Patients who received these devices should contact their healthcare provider if they experience any symptoms of concern. Healthcare facilities in Virginia that received devices from this lot should identify affected patients and consult FDA guidance for appropriate next steps.
The recalled product
- Product
- DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012195
- Manufacturer
- Angiodynamics, Inc.
- Category
- Medical Device — Vascular Access
- Hazard
- metal-shavings
- 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: 25051684014837 Lot Numbers: 5807415
Distribution
Distributed in 1 state:
- VA
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