Vascular access device recalls due to metal shaving contamination risk
Angiodynamics is recalling the BioFlo DuraMax 15.5F Single Valve Sheath VascPak Kit due to possible loose metal shavings. Metal shavings could enter the bloodstream and require 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: The recall is FDA Class II with a theoretical risk of serious harm from metal shaving embolization potentially requiring surgical removal. No illnesses or injuries have been reported.
Plain-English summary
Angiodynamics, Inc. is recalling the BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit, a medical device used for long-term vascular access in hemodialysis and apheresis procedures. The recall affects 250 units distributed in Virginia under Lot Number 5810278.
The device may contain loosely affixed metal shavings. If these shavings become dislodged, they could enter the bloodstream and travel through blood vessels, a condition that could require surgical intervention to remove the foreign material.
Healthcare providers with affected devices should stop using them immediately. If you or your healthcare provider has received or used one of these devices, contact your healthcare provider for further guidance.
The recalled product
- Product
- BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H965103038181
- Manufacturer
- Angiodynamics, Inc.
- Affected units
- 250
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: 25051684025680 Lot Numbers: 5810278
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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