FDA recall Z-1155-2021

Bovie Medical Corporation · Class II · device

Product

ConMed 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.

Distribution

US Nationwide distribution in the states of CA and FL.

Key facts

Status
Ongoing
Initiation date
2021-02-01
Report date
2021-03-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Clearwater, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1155-2021