Bovie Medical Corporation recalls HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft…

Recall date

February 1, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1154-2021

FDA classification

Class II

Brand / firm

Bovie Medical Corporation

Sold / distributed

US Nationwide distribution in the states of CA and FL.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.