FDAFDA · Food and drugs·Recall number Z-1761-2024
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
Published May 15, 2024 · Recall initiated: March 18, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Angiodynamics, Inc.
- Distributor
- VA
- Lot
- UDI-DI: 15051684014748 Lot Numbers: 5805837
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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