BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak recall: Foreign Material
BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis.…
Why was BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak recalled?
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI-DI: 25051684025680 Lot Numbers: 5810278
- Product
- BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis.…
- Recalling firm
- Angiodynamics, Inc.
- Quantity
- 250 units
- Distribution
- VA
- Recall date
- May 15, 2024
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)