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U.S. Department of Health and Human Services

Class 2 Device Recall Angiodynamics 5F Standard MicroIntroducer Kit

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 Class 2 Device Recall Angiodynamics 5F Standard MicroIntroducer Kitsee related information
Date Initiated by FirmOctober 14, 2020
Create DateNovember 05, 2020
Recall Status1 Terminated 3 on October 19, 2021
Recall NumberZ-0418-2021
Recall Event ID 86627
510(K)NumberK051655 
Product Classification Cannula, catheter - Product Code DQR
ProductAngiodynamics 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 ContactSAME
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
ActionAngiodynamics 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 Commerce32 kits
DistributionUS Nationwide distribution including in the states of AL, CT, GA, FL.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DQR
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