Device product
DURAMAX STACKED TIP 28CM STR. BASIC KIT, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028041
Z-1768-2024
Product summary
- Event
- Event 94349
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 30 units
- Official record key
device-enforcement:Z-1768-2024
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: 15051684011846 Lot Numbers: 5805840
Distribution pattern: VA
Derived failure modes
-
Foreign material or chemical contamination
metal shavings