Medical device recalls Moderate risk

Integra LifeSciences Corp. recalls Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments

Recall date
March 7, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1867-2016
FDA classification
Class II
Brand / firm
Integra LifeSciences Corp.
Sold / distributed
AR, CA, CO, FL, IN, KY, MA, MI, NC, NJ, NY, NM, OH, TN, TX, WA and WI

Why it was recalled

Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.

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

What was recalled

Integra MicroFrance Monopolar and Bipolar Electrosurgical Instruments

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