Device product
DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012021
Z-1761-2024
Product summary
- Event
- Event 94349
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 157 units
- Official record key
device-enforcement:Z-1761-2024
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: 15051684014748 Lot Numbers: 5805837
Distribution pattern: VA
Derived failure modes
-
Foreign material or chemical contamination
metal shavings