Integra LifeSciences Corp. recalls Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during gen…

Recall date

July 19, 2019

Source

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

Recall number

Z-2206-2019

FDA classification

Class II

Brand / firm

Integra LifeSciences Corp.

Sold / distributed

KY,NJ, RI, TX, WA Foreign: BE

Why it was recalled

Tips have an inadequate product insulation coating, which could result in the tips not coagulating as expected

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

What was recalled

Codman ISOCOOL Bipolar Forceps-are indicated for cauterizing, coagulating, grasping, and manipulating tissue during general surgery, neurosurgery, ENT surgery, OB/GYN surgery, and maxillofacial / plastic surgery procedures. Model # 8145100S