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DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascu...

FDA Recall #Z-1761-2024 — Class II — March 18, 2024

Recall #Z-1761-2024 Date: March 18, 2024 Classification: Class II Status: Ongoing

Product Description

DURAFLOW 2, 28CM STRAIGHT BASIC KIT, 1 per Bx PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012021

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

157 units

Distribution

VA

Code Information

UDI-DI: 15051684014748 Lot Numbers: 5805837

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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