Reported Apr 1, 2015 · Terminated
Coblator II System, 120V. Product Usage: The Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical…
ArthroCare Medical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ArthroCare Medical Corporation · 7000 W William Cannon Dr · Austin, TX · 78735-8509
Is this the product you have?
- Coblator II System, 120V
- Product UsageThe Coblator II (Model RF8000E) is a bipolar, radiofrequency electrosurgical system designed for use in otorhinolaryngology (ENT) surgery. The system
- consists of the following componentsan 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
- Lot codes and dates
- Serial Numbers
CA0N0000FTCA0N0000H0CA0N0000H7CA0N0000J6CA0N0000KJCA0N0000KKCA0N0000KLCA0N0000FWCA0N0000G5CA0N0000G6CA0N0000H1CA0N0000FRCA0N0000FZCA0N0000KFCA0N0000GH
- Serial Numbers
- Amount recalled
- 15 units
Where it was sold
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).
This product could cause temporary or reversible health problems — stop using it.
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