🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: February 20, 2015 ArthroCare Medical Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Serial Numbers: CA0N0000FT, CA0N0000H0, CA0N0000H7, CA0N0000J6, CA0N0000KJ, CA0N0000KK, CA0N0000KL, CA0N0000FW, CA0N0000G5, CA0N0000G6, CA0N0000H1, CA0N0000FR, CA0N0000FZ, CA0N0000KF, CA0N0000GH
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
ArthroCare Medical Corporation
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).
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

Serial Numbers: CA0N0000FT, CA0N0000H0, CA0N0000H7, CA0N0000J6, CA0N0000KJ, CA0N0000KK, CA0N0000KL, CA0N0000FW, CA0N0000G5, CA0N0000G6, CA0N0000H1, CA0N0000FR, CA0N0000FZ, CA0N0000KF, CA0N0000GH

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1323-2015

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