Recall Z-1774-2024 ยท MSD Catheter, Hemodialysis, Implanted
Angiodynamics, Inc.
BioFlo DuraMax 15.5F 24cm Single Valve Sheath VascPak Kit- Indicated for use in attaining Long-Term vascular access for Hemodialysis and Apheresis. Product Number: H965103038181
| 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 | 250 units |
| Distribution | VA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131260 | NMI DIALYSIS CATHETER Navilyst Medical, Inc., Feb 14, 2014 |