Date Initiated by Firm |
October 14, 2020 |
Create Date |
November 05, 2020 |
Recall Status1 |
Terminated 3 on October 19, 2021 |
Recall Number |
Z-0418-2021 |
Recall Event ID |
86627 |
510(K)Number |
K051655
|
Product Classification |
Cannula, catheter - Product Code DQR
|
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
|
Code Information |
Lot Number: 5626935 Expiration Date: 08/31/2023 |
Recalling Firm/ Manufacturer |
Angiodynamics, Inc. 603 Queensbury Ave Queensbury NY 12804-7619
|
For Additional Information Contact |
SAME 518-798-1215
|
Manufacturer Reason for Recall |
5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
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. |
Quantity in Commerce |
32 kits |
Distribution |
US Nationwide distribution including in the states of AL, CT, GA, FL. |
Total Product Life Cycle |
TPLC Device Report
|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = DQR and Original Applicant = ANGIODYNAMICS, INC.
|