Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355
Recall
- Recall Number
- Z-0418-2021
- Event Number
- 86627
- Firm
- Angiodynamics, Inc.
- FEI Number
- 1319211
- Product Code
- DQR
- Status
- Terminated
- Root Cause
- Under Investigation by firm
- Initiated
- October 14, 2020
- Terminated
- October 19, 2021
- Address
- 603 Queensbury Ave, Queensbury, NY, 12804-7619
Description
Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355
5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component
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.
US Nationwide distribution including in the states of AL, CT, GA, FL.
32 kits