Z-1770-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2024
- Initiation Date
- March 18, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 260 units
Product Description
DURAMAX STACKED TIP 32CM STR. BASIC KIT, 5-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028055
Reason for Recall
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Distribution Pattern
VA
Code Information
UDI-DI: 25051684011850 Lot Numbers: 5809646