FDA Device

Model 6149 Pacing Vector Selector Cable Switch for use with Pacing System Analyzers * Rx only * Contents Are Not Sterile * Manufactured by Remington Medical Incorporated, 6830 Meadowridge Court, Alpharetta, GA 30005, (770) 888-8520 or (800) 999-0057 * Distributed By: Guidant Corporation, 4100 Hamine Avenue North, St. Paul, MN 55112-5798 USA.

Hazard

The vector selector has an electrical design flaw which prevents RV pacing.

What You Should Do

Remedy

Guidant Corporation notified Remington Medical of the problem. Remington had instructed Guidant to retrieve the product from their sales force by 09/07/2005 and return to Remington by 09/09/2005.

Products

Model 6149 Pacing Vector Selector Cable Switch for use with Pacing System Analyzers * Rx only * Contents Are Not Sterile * Manufactured by Remington Medical Incorporated, 6830 Meadowridge Court, Alpha
Brand
Remington Medical Inc.
UPC
Lot number: 051781, 051782, 051783, 051788, 0517939.

Units Affected

600 units