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

FDA Recall #Z-1766-2024 — Class II — March 18, 2024

Recall #Z-1766-2024 Date: March 18, 2024 Classification: Class II Status: Ongoing

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.

Recalling Firm

Angiodynamics, Inc. — Queensbury, NY

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

50 units

Distribution

VA

Code Information

UDI-DI: 15051684011839 Lot Numbers: 5809463

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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