—#184211

Product

Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355

FDA product code: DQR — Cannula, Catheter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K051655
Affected lot / code info: Lot Number: 5626935 Expiration Date: 08/31/2023

Why it was recalled

5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Angiodynamics initiated on October 14, 2020 Urgent Medical Device Recall Notification via Federal Express consignees. The recall letter states reason for recall, health risk and action to take: 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. If affected product is located in your institution, please call AngioDynamics Customer Service at 1-800- 772-6446 between 8:00 a.m. and 7:00 p.m. (Monday Friday: Eastern Standard Time) to obtain a replacement or credit for your returned product. " 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.

Recalling firm

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

Distribution

Distribution pattern: US Nationwide distribution including in the states of AL, CT, GA, FL.

Timeline

Recall initiated: 2020-10-14
Terminated: 2021-10-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184211. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.