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DuraMax recallZ-1766-2024 · Angiodynamics, Inc. · initiated Mar 18, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Angiodynamics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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): [email protected] 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

Recall details

Recall number
Z-1766-2024
Status
Open, Classified
Initiated by the company
Mar 18, 2024
Posted by the FDA
May 3, 2024
Recalling firm
Angiodynamics, Inc.
Quantity
50 units
Product code
MSD
FDA submissions
K101843
Distribution
VA

Product description

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

Code information (models, lots, serial numbers)

UDI-DI: 15051684011839 Lot Numbers: 5809463

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

7 devices cleared under K101843 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 94349).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page