FDA Medical Device Recalls (openFDA)
Angiodynamics Worldwide Headquarters: Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 22cm Chronic Hemodialysis VascPak (with Cuff 17cm from Tip) --- Catalog No. [REF] 10302817 --- 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 number
- Z-0725-2012
- Recalling firm
- Angiodynamics Worldwide Headquarters
- Product
- Angiodynamics DuraMax VP Vascpak Catheter Kit 15.5F x 22cm Chronic Hemodialysis VascPak (with Cuff 17cm from Tip) --- Catalog No. [REF] 10302817 --- 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.
- Status
- Terminated
- Initiated
- 2011-12-30
- Posted
- 2012-01-12
- Terminated
- 2016-02-10
- Reason
- The securement cuff on the hemodialysis catheter has the potential to detach from the shaft.
- 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
- not on file
- Distribution
- Worldwide Distribution - USA (Nationwide)
- Lot, serial or model codes
- FG Lot Numbers: C37756
- 510(k) numbers
- ["K101843"]
- PMA numbers
- not on file
- Product code
- MSD
- Firm FEI
- 3008319439
- Firm city
- Latham
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28