DURAMAX (TM) Hemodialysis Catheters, Stack Tip 36 cm Pre-Curve Basic Kit, Catalog Number/REF 10302815, 510 (k) 080400, S

FDA device recall Z-1771-2010 · posted 2010-06-04 · Terminated

Recall details

Recalling firm

Angiodynamics, Inc.

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

MSD

Quantity affected

26

Distribution

Nationwide and St. Thomas, VI

Date initiated

2010-01-08

Date posted

2010-06-04

Date terminated

2012-07-25

Location

Queensbury, NY