FDA Medical Device Recalls (openFDA)
Angiodynamics, Inc.: DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012115
- Recall number
- Z-1763-2024
- Recalling firm
- Angiodynamics, Inc.
- Product
- DURAFLOW 2, 55CM STRAIGHT BASIC KIT PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012115
- Status
- Open, Classified
- Initiated
- 2024-03-18
- Posted
- 2024-05-03
- Terminated
- not on file
- Reason
- Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
- Root cause
- Under Investigation by firm
- Action
- 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
- Quantity
- 188 units
- Distribution
- VA
- Lot, serial or model codes
- UDI-DI:15051684014786 Lot Numbers: 5805171
- 510(k) numbers
- ["K110936"]
- PMA numbers
- not on file
- Product code
- MSD
- Firm FEI
- 1319211
- Firm city
- Queensbury
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28