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Terminated

Angiodynamics DuraMax 55 cm STRAIGHT --- 1-15.5F x 55cm DuraMax Hemodialysis Catheter (with Cuff 50cm from Tip), 2- Injection Caps --- Catalog No. [REF] 10302909 --- 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.

FDA Recall Z-0733-2012 · Posted 2012-01-12

Recall StatusTerminated
Product CodeMSD
Date Initiated2011-12-30
Date Terminated2016-02-10
Product Quantity21 units

Reason for Recall

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

Firm Action

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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - USA (Nationwide)

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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