Recall Z-1154-2021 · GEI Electrosurgical, Cutting & Coagulation & Accessories
Bovie Medical Corporation
HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
| Date | Feb 1, 2021 |
| Status | Open, Classified |
| Reason | There can be a potential breach of the sterile packaging barrier due to the development of pinholes at the crease of the double-folded edge of the current package configuration. |
| Root cause | Device Design |
| Action | The firm sent "URGENT MEDICAL DEVICE RECALL" (FA-2021-1) and response form to customers on February 1, 2021. |
| Quantity | 3862 units |
| Distribution | US Nationwide distribution in the states of CA and FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K161558 | Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, N Bovie Medical Corporation, Jul 29, 2016 |