Angiodynamics DuraMax 15.5F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31cm from Tip) --- Catalog No. [REF] 10302806 --- 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.
Recall
- Recall Number
- Z-0722-2012
- Event Number
- 60804
- Firm
- Angiodynamics Worldwide Headquarters
- FEI Number
- 3008319439
- Product Code
- MSD
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- December 30, 2011
- Posted
- January 12, 2012
- Terminated
- February 10, 2016
- Address
- 14 Plaza Drive, Latham, NY, 12110-3421
Description
Angiodynamics DuraMax 15.5F x 36 cm Chronic Hemodialysis Catheter Set (With Cuff 31cm from Tip) --- Catalog No. [REF] 10302806 --- 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.
The securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
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.
Worldwide Distribution - USA (Nationwide)
17 units