Recall Z-0418-2021
Angiodynamics, Inc. · initiated October 14, 2020
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot Number: 5626935 Expiration Date: 08/31/2023
Reason for recall
5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component
FDA-determined cause: Under Investigation by firm
Action taken
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.
Details
- Recall number
- Z-0418-2021
- Initiated
- October 14, 2020
- Terminated
- October 19, 2021
- Product code
- DQR – Cannula, Catheter
- Quantity
- 32 kits
- Distribution
- US Nationwide distribution including in the states of AL, CT, GA, FL.
- Recalling firm
- Angiodynamics, Inc., Queensbury, NY