Coblator II System recalled over sterility concerns

Recall date

February 20, 2015

Source

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

Official notice title

ArthroCare Medical Corporation recalls Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical s…

Recall number

Z-1323-2015

FDA classification

Class II

Brand / firm

ArthroCare Medical Corporation

Sold / distributed

US Nationwide Distribution in the states of TN, IA, AZ, NE, SD, NY, and OK.

Why it was recalled

The recalling firm was notified by the contract manufacturer that they had reversed the L2, L3, L4, or L5 components on the P/N09010 RoHS boards of the Coblator II Controller (Model RF8000E).

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

What was recalled

Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surgery. The system consists of the following components: an electrosurgical radiofrequency controller, a reusable, non-sterile Power Cord; a reusable, non-sterile Foot Control; a reusable, non-sterile Flow control Valve Unit; a reusable, non-sterile flow control cable; a single use, disposable, sterile Wand. The Coblator II is indicated for ablation, resection, and coagulation of soft tissue and hemostasis of blood vessels in otorhinolaryngology (ENT) surgery.