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Angiodynamics DuraMax 15.5F x 32 cm Chronic Hemodialysis… recallZ-0718-2012 · Angiodynamics Worldwide Headquarters · initiated Dec 30, 2011

Terminated All recalls posted in January 2012

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 Worldwide Headquarters 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

The securement cuff on the hemodialysis catheter has the potential to detach from the shaft.

FDA root cause category: Nonconforming Material/Component

What the company is doing

AngioDynamics sent an Urgent - Medical Device Recall letter dated December 30, 2011, via certified mail to all affected customers. The letter identified the affected product, the problem, and the actions to be taken. Customers were instructed to examine inventory, segregate the recalled lots and return remaining inventory to the firm. The letter states that replacement product will be shipped upon receipt and confirmation of the returned product. Customers were advised to complete the Recall Reply Form included and fax to DuraMax Hemodialysis Catheter Recall Coordinator at 518-798-1360. For questions contact your local representative or call the Customer Service Manger at ANGIODYNAMICS Customer Service at 1-800-772-6446.

Recall details

Recall number
Z-0718-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Dec 30, 2011
Posted by the FDA
Jan 12, 2012
Recalling firm
Angiodynamics Worldwide Headquarters
Quantity
950 units
Product code
MSD
FDA submissions
K101843
Distribution
Worldwide Distribution - USA (Nationwide)

Product description

Angiodynamics DuraMax 15.5F x 32 cm Chronic Hemodialysis Catheter Set (with Cuff 27cm from Tip) --- Catalog No. [REF] 10302805 --- MANUFACTURED IN USA AngioDynamics, Inc., 603 Queensbury Avenue, Queensbury, NY USA 12804 Product Usage: indicated for use in attaining long-term vascular access for Hemodialysis and Apheresis.

Code information (models, lots, serial numbers)

FG Lot Numbers: 541559, C37646, C37650, C41145

Other devices under the same FDA submission

8 devices cleared under K101843 — the recall does not name any of them by identifier. 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 60804).

Sources and updates

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