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Bovie Medical Corporation recalls HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft
Recalled March 10, 2021 · FDA recall Z-1154-2021 · Bovie Medical
Hazard
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. · FDA Class II
Units
3862 units
Sold at
US Nationwide distribution in the states of CA and FL.
Description
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.
Product
HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
Manufacturer(s)
Bovie Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →