FDA Enforcement
Class II
Ongoing
DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028191
Recall: Z-1771-2024
·
Reported May 15, 2024
Enforcement
- Recall Number
- Z-1771-2024
- Event ID
- 94349
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Angiodynamics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- May 15, 2024
- Initiation Date
- March 18, 2024
- Classification Date
- May 3, 2024
- Address
- 603 Queensbury Ave, N/A, Queensbury, NY, 12804-7619, United States
Description
DURAMAX STACKED TIP 28 CM STRAIGHT VASC-PAK, 1-UP PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103028191
Reason
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
Code Info
UDI-DI: 25051684011850 Lot Numbers: 5807208
Distribution
VA
Quantity
15 units