DURAMAX 15.5 F x 24 cm Chronic Hemodialysis Catheter Set (With Cuff 19 cm from Tip), DuraMax Stacked Tip 24 cm Str. Basi

FDA device recall Z-0587-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Angiodynamics, Inc.

Reason for recall

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

MSD

Quantity affected

537 units

Distribution

Nationwide distribution.

Date initiated

2011-01-24

Date posted

2012-01-11

Date terminated

2016-02-02

Location

Queensbury, NY

Related 510(k) clearances