Recall Z-1153-2021— Bovie Medical Corporation
Class II · Ongoing
Class II FDA medical device recall by Bovie Medical Corporation, initiated 2021-02-01. It names 2 FDA 510(k) clearances: K161558, K152777. Product: Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.. 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..
- Recalling firm
- Bovie Medical Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2021-02-01
- Firm location
- Clearwater, FL, United States
510(k) clearances named in this recall
2 on FDA's record- K161558 — Bovie 3.3mm Disposable Bipolar Ablator 90°, Aspirating and Non-Aspirating, Bovie 2.4mm Disposable Bipolar Ablator 55°, Non-Aspirating, Bovie 1.8mm Disposable Bipolar Ablator 60°, Non-Aspirating
- K152777 — Bovie Disposable Bipolar Ablator
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Velocity Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.