—#91604

Product

DURAMAX (TM) Hemodialysis Catheters, Stacked Tip 28 cm Straight Basic Kit, Catalog Number/REF 10302804, 510 (k) 080400, Sterile --- Manufactured in USA by AngioDynamics, Inc. 603 Queensbury Avenue, Queensbury, NY 12804

FDA product code: MSD — Catheter, Hemodialysis, Implanted
Device class: Class 2
Medical specialty: Gastroenterology, Urology
Affected lot / code info: Lots 978911, 980647, 981114, 981844, 982372, C68435, C68436, C68437, C68438, C68439, 981964

Why it was recalled

The product has the potential for a cross-lumen leak. One of the two leak testers that are used to perform the leak test on the DuraMax Catheters was found to be faulty. The tester was not able to detect cross-lumen leaks. Both testers were used during the manufacturing 100% leak test.

Root cause (FDA determination)

Other

Action the firm took

Customers were sent URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/07/10) via Certified Mail, Return Receipt Requested. Customers were instructed to return all recalled product. A return authorization number was assigned to each customer in the recall notification letter and a UPS account was provided for return freight. A reply form was provided in the recall notification letter. Questions were directed to the company sales representatives or to Customer Service at 800-772-6446.

Recalling firm

Firm: Angiodynamics, Inc.
Address: 603 Queensbury Avenue, Queensbury, New York 12804

Distribution

Distribution pattern: Nationwide and St. Thomas, VI

Timeline

Recall initiated: 2010-01-08
Posted by FDA: 2010-06-04
Terminated: 2012-07-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91604. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.