—#208735

Product

SOFT-VU KUMPE 5F X 40CM -Used for patients in need of angiographic diagnosis. Catalog Number: 10732702

FDA product code: DQO — Catheter, Intravascular, Diagnostic
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K173762
Affected lot / code info: UPN: H787107327025 UDI-DI: 25051684009789 (Box) 15051684009782 (Pouch) Lot Number: A0424035

Why it was recalled

Mislabeled. The shelf-box labeling (unit of sale) is accurate for the packaged devices, however the inner pouch label may contain information for a different model (catheter length)

Root cause (FDA determination)

Packaging change control

Action the firm took

Angiodynmaics issued Urgent Medical Device Recall Letter on 6/18/24 via Federal Express to end-users. Letter states reason for recall, health risk and action to take: " IMMEDIATELY o Stop using the product subject to recall. o Remove any affected (recalled) product from your inventory (whether in labs, Central Supply, Shipping and Receiving or ANY other location). o Segregate this product in a secure location for return to AngioDynamics, Inc. o Forward a copy of this recall notification to all sites to which you have distributed affected product. 2. Complete and return the Reply Verification Tracking Form. Promptly complete, sign, and return the enclosed Reply Verification Tracking Form (even if you do not have any product to return); following the directions on this page and the Reply Verification Tracking Form. Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com Fax Reply Verification Tracking Form: Attn: Soft-Vu Kumpe Recall Coordinator Fax number 1-855-273-0519 " Call AngioDynamics Customer Service at 1-800-772-6446 between 8:00 a.m. and 6:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. " Report any Adverse reactions or quality problems associated with recalled devices to US FDA via MedWatch Adverse Event Reporting program either online, by regular mail or by fax. 3. Package and Return the Recalled Product. " Package any product that is being returned in an appropriate shipping box. " Write the RMA number on the RMA/Address label (provided on the Recall Verification Tracking Form) and affix the label to the outside of the shipping box. " Seal the box and return to: AngioDynamics, Inc. 24 Native Drive Queensbury, NY 12804 Attn: Soft-Vu Kumpe Recall Coordinator

Recalling firm

Firm: Angiodynamics, Inc.
Address: 603 Queensbury Ave, Queensbury, New York 12804-7619

Distribution

Distribution pattern: US Nationwide distribution.

Timeline

Recall initiated: 2024-06-18
Posted by FDA: 2024-07-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #208735. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.