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Terminated

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 Recall Z-0418-2021 · Posted None

Recalling FirmAngiodynamics, Inc.
Recall StatusTerminated
Product CodeDQR
Date Initiated2020-10-14
Date Terminated2021-10-19
Product Quantity32 kits

Reason for Recall

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

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.

Root Cause

Under Investigation by firm

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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