Device recall
Z-0526-2018: Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN)…
FDA device recall · Class II · Angiodynamics, Inc.
Key facts
| Recall number (Z-number) | Z-0526-2018 |
|---|---|
| Recall event | 77631 |
| Product | Accu2i pMTA Applicator, 14 cm STANDARD, REF/Catalog # 900-600, Model # (UPN) H7879006000, STERILE --- This is only for use with a Sulis V Generator, REF 806-10. Product Usage: The Acculis Accu2i pMTA Microwave Tissue Ablation Applicator is indicated for the intraoperative coagulation of soft tissue. |
| Product code | NEY |
| Recalling firm | Angiodynamics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 11, 2018 |
| 510(k) numbers | K094021 |
| FEI number | 1319211 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database