Z-1764-2024 Class II Ongoing
FDA device recall Z-1764-2024 was initiated by Angiodynamics, Inc. on Mar 18, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 83 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 15, 2024
- Initiation Date
- Mar 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 83 units
Product Description
DURAFLOW 2, 24CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012185
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: 25051684014820 Lot Numbers: 5805849
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1764-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026