Device 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
Z-1774-2024
Product summary
- Event
- Event 94349
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 250 units
- Official record key
device-enforcement:Z-1774-2024
Official wording
Reason: Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Code information: UDI-DI: 25051684025680 Lot Numbers: 5810278
Distribution pattern: VA
Derived failure modes
-
Foreign material or chemical contamination
metal shavings