Recall Z-0418-2021 ยท DQR Cannula, Catheter
Angiodynamics, Inc.
Angiodynamics 5F Standard Micro-Introducer Kit - indicated for percutaneous introduction of a guidewire or catheter into the vascular system, Catalog Number: 06597035 UPN: H787065970355
| Date | Oct 14, 2020 |
| Status | Terminated |
| Reason | 5F Micro-Introducer Kits may not contain the correct device, packaged with a 4F Sheath/Dilator component |
| 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 yo |
| Quantity | 32 kits |
| Distribution | US Nationwide distribution including in the states of AL, CT, GA, FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K051655 | ANGIODYNAMICS, INC., MICRO ACCESS KITS AngioDynamics, Inc., Sep 12, 2005 |