Z-1766-2024 Class II Ongoing

Recalled by Angiodynamics, Inc. — Queensbury, NY

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
50 units

Product Description

DURAMAX STACKED TIP 24CM STR. BASIC KIT, 1-UP PG Product Number: H787103028031

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: 15051684011839 Lot Numbers: 5809463