Z-0418-2021Class II

Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or...

Name: Z-0418-2021 Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or...
Creator: Angiodynamics, Inc.
Published: 2020-10-14
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2020-10-14 / Terminated / root cause: packaging

FDA source

Angiodynamics, Inc. began a recall of Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number... on 2020-10-14. FDA classified it as Class II and gives the reason as "5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0418-2021
Classification: Class II
Status: Terminated
Initiated: 2020-10-14
Posted: 2020-11-05
Terminated: 2021-10-19
Recalling firm: Boston Scientific Corporation
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
Product code: DQR Cannula, Catheter
Reason for recall: 5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component
Root cause tag: packaging
FDA root cause: 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.
Product codes and lots: Lot Number: 5626935 Expiration Date: 08/31/2023

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0418-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0418-2021	Class II	Terminated	Voluntary: Firm initiated	2020-11-11	2020-11-05

Product code DQR

K051655Class IIAngiodynamics, Inc., Micro Access KitsAngioDynamics, Inc. / cleared 2005-09-12

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)