FDA-Device2021-03-10Class II
HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
Bovie Medical Corporation
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.
Sold states
US Nationwide distribution in the states of CA and FL.
Affected count
3862 units
Manufactured in
5115 Ulmerton Rd, Clearwater, FL, United States
Products
HNM Disposable Bipolar Ablators - Product Usage: intended to be used for cutting, vaporization, and coagulation of soft tissue during arthroscopic surgical procedures.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1154-2021Don't want to check this manually?
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