—#103835

Product

DURAMAX 15.5 F x 24 cm Chronic Hemodialysis Catheter Set (With Cuff 19 cm from Tip), DuraMax Stacked Tip 24 cm Str. Basic Kit, Catalog No./REF 10302803, STERILE --- AngioDynamics, Inc. 603 Queensbury, NY 12804 USA The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis.

FDA product code: MSD — Catheter, Hemodialysis, Implanted
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K080400, K101843
Affected lot / code info: Lots 500137, 500138, 527756, C28713

Why it was recalled

AngioDynamics received customer complaints for breakage of the tunneler sleeve during product use.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

The firm, AngioDynamics, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 28, 2011 and response form via Certified Mail, Return Receipt Requested, to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to identify and segregate the recalled lots; complete and return the enclosed DuraMax HemoDialysis Catheter Recall Reply Form via fax to: Attn: DuraMax HemoDialysis Catheter Recall Coordinator at 518-798-1360 (even if they don't have any product); and do not use the affected product, return and ship the recalled product to ANGIODYNAMICS (replacement product will be shipped upon receipt and confirmation of the returned product). If the customers are in immediate need for replacement product, they should fax the completed Recall Reply Form, along with a copy of the product label, to Customer Service at (518) 798-1360 or call us at (800) 772-6446, x1358 or x1363. If you have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please do not hesitate to contact your local sales representative or call ANGIODYNAMICS customer service at 1-800-772-6446 or email to: customerservice@angiodynamics.com.

Recalling firm

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

Distribution

Distribution pattern: Nationwide distribution.

Timeline

Recall initiated: 2011-01-24
Posted by FDA: 2012-01-11
Terminated: 2016-02-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103835. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.