Recall Z-1323-2015— ArthroCare Medical Corporation

Name: FDA recall Z-1323-2015
Creator: U.S. Food and Drug Administration
Published: 2015-02-20

Class II · Terminated

Class II FDA medical device recall by ArthroCare Medical Corporation, initiated 2015-02-20, terminated 2016-02-26. It names one FDA 510(k) clearance: K030108. Product: 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.. Reason: 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)..

Recalling firm: ArthroCare Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-02-20
Terminated: 2016-02-26
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K030108 — ARTHROCARE ENT COBLATOR SURGERY SYSTEMArthrocare Corp.·cleared 2003-02-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

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).

Data sourced from openFDA. This site is unofficial and independent of the FDA.