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DURAMAX 15.5 F x 22 cm Chronic Hemodialysis Catheter Set… recallZ-0586-2012 · Angiodynamics, Inc. · initiated Jan 24, 2011

Terminated All recalls posted in January 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Angiodynamics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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: [email protected].

Recall details

Recall number
Z-0586-2012
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 24, 2011
Posted by the FDA
Jan 11, 2012
Recalling firm
Angiodynamics, Inc.
Quantity
12 units
Product code
MSD
FDA submissions
K080400, K101843
Distribution
Nationwide distribution.

Product description

DURAMAX 15.5 F x 22 cm Chronic Hemodialysis Catheter Set (With Cuff 17 cm from Tip), DuraMax Stacked Tip 22 cm Str. Basic Kit, Catalog No./REF 10302802, STERILE --- AngioDynamics, Inc. 603 Queensbury, NY USA 12804. The AngioDynamics DuraMax Chronic Hemodialysis Catheter is indicated for use in attaining long-term vascular access for Hemodialysis and apheresis.

Code information (models, lots, serial numbers)

Lot C28712

Other devices under the same FDA submission

8 devices cleared under K080400, K101843 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 59833).

Sources and updates

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