DURAFLOW 2, 32CM STRAIGHT BASIC KIT PG-Indicated for use in attaining Long-Term vascular access for Hemodialysis and Aph
FDA device recall Z-1762-2024 · posted 2024-05-03 · Open, Classified
Recall details
- Recalling firm
- Angiodynamics, Inc.
- Reason for recall
- Tri-Ball Tunneler may contain loosely affixed metal shavings, potential for the metal shaving to embolize, possibly requiring removal via surgical procedure.
- Action taken
- 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 product to return), following the directions on this page and the Reply Verification Tracking Form. Email Reply Verification Tracking Form (preferred): recall@angiodynamics.com Fax Reply Verification Tracking Form: Attn: Hemodialysis Catheter Kits with Tri-Ball Tunneller Fax number 1-855-273-0519 " 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. Package any product that is being returned in an appropriate shipping box. " Write the RMA number on the RMA label (provided on the Recall Verification Tracking Form) and affix the label to the outside of the shipping box. " Seal the box and return via your preferred carrier to: AngioDynamics, Inc. 24 Native Drive Queensbury, NY 12804 Attn: Hemodialysis Catheter Kits with Tri-Ball Tunneller
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- MSD
- Quantity affected
- 35 units
- Distribution
- VA
- Date initiated
- 2024-03-18
- Date posted
- 2024-05-03
- Location
- Queensbury, NY
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT (K110936) | AngioDynamics, Inc. | 2011-06-10 |