—#206992

Product

BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H965103038181

FDA product code: MSD — Catheter, Hemodialysis, Implanted
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K131260
Affected lot / code info: UDI-DI: 25051684025680 Lot Numbers: 5810278

Why it was recalled

Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Angiodynamics issued Recall Notifications Packages via Federal Express to 1 Domestic Consignee on 2024-03-18 . Letter states reason for recall, health risk and action to take: IMMEDIATELY o Locate the affected product in your Inventory, cease any and all distribution segregate in a secure location pending return. o Forward a copy of this recall notification to any locations to which you have distributed affected product. 2. Complete and return the Reply Verification Tracking Form. " Promptly complete, sign, and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return), following the directions on this page and the Reply Verification Tracking Form. Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com Fax Reply Verification Tracking Form: Attn: Hemodialysis Catheter Kits with Tri-Ball Tunneller Fax number 1-855-273-0519 " Call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. Package any product that is being returned in an appropriate shipping box. " Write the RMA number on the RMA label (provided on the Recall Verification Tracking Form) and affix the label to the outside of the shipping box. " Seal the box and return via your preferred carrier to: AngioDynamics, Inc. 24 Native Drive Queensbury, NY 12804 Attn: Hemodialysis Catheter Kits with Tri-Ball Tunneller

Recalling firm

Firm: Angiodynamics, Inc.
Address: 603 Queensbury Ave, Queensbury, New York 12804-7619

Distribution

Distribution pattern: VA

Timeline

Recall initiated: 2024-03-18
Posted by FDA: 2024-05-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #206992. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.