Recall Z-1765-2024 ยท MSD Catheter, Hemodialysis, Implanted
Angiodynamics, Inc.
DURAFLOW 2, 28CM STRAIGHT VASC-PAK PG- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H787103012195
| Date | May 3, 2024 (initiated Mar 18, 2024) |
| Status | Open, Classified |
| Reason | Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure. |
| Root cause | Under Investigation by firm |
| Action | Angiodynamics issued Recall Notifications Packages via Federal Express to 1 Domestic Consignee on 2024-03-18 . Letter states reason for recall, health risk and action to take: IMMEDIATELY o Locate the affected product in your Inventory, cease any and all distribution segregate in a secure location pending return. o Forward a copy of this recall notification to any locations to which you have distributed affected product. 2. Complete and return the Reply Verification Tracking Form. " Promptly complete, sign, and return the enclosed Reply Verification Tracking Form (even if you do not have any |
| Quantity | 65 units |
| Distribution | VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110936 | DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT AngioDynamics, Inc., Jun 10, 2011 |