Z-0721-2012

Angiodynamics DuraMax 15.5F x 28 cm Chronic Hemodialysis Catheter Set (with Cuff 23cm from Tip) --- Catalog...

Name: Z-0721-2012 Angiodynamics DuraMax 15.5F x 28 cm Chronic Hemodialysis Catheter Set (with Cuff 23cm from Tip) --- Catalog...
Creator: Angiodynamics Worldwide Headquarters
Published: 2011-12-30
License: https://open.fda.gov/license/

Angiodynamics Worldwide Headquarters / initiated 2011-12-30 / Terminated / root cause: manufacturing process

FDA source

Angiodynamics Worldwide Headquarters began a recall of Angiodynamics DuraMax 15.5F x 28 cm Chronic Hemodialysis Catheter Set (with Cuff 23cm from Tip) --- Catalog No. [REF] 10302804 --- MANUFACTURED IN USA... on 2011-12-30. The reason FDA records is "The securement cuff on the hemodialysis catheter has the potential to detach from the shaft". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0721-2012
Status: Terminated
Initiated: 2011-12-30
Posted: 2012-01-12
Terminated: 2016-02-10
Recalling firm: Angiodynamics Worldwide Headquarters
Product: Angiodynamics DuraMax 15.5F x 28 cm Chronic Hemodialysis Catheter Set (with Cuff 23cm from Tip) --- Catalog No. [REF] 10302804 --- 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.
Product code: MSD Catheter, Hemodialysis, Implanted
Reason for recall: The securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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.
Quantity in commerce: 1336 units
Distribution: Worldwide Distribution - USA (Nationwide)
Product codes and lots: FG Lot Numbers: 541558, 542262, 542266, 543822, 543823, 556670, 556672, C40503

Product code MSD

K101843Class IIDuramax Chronic Hemodialysis Catheter and Procedure KitAngioDynamics, Inc. / cleared 2010-10-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)