Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0124-06

Model 6149 Pacing Vector Selector Cable Switch for use with Pacing System Analyzers * Rx only * Contents Are...

Remington Medical / initiated 2005-08-31 / Terminated / root cause: design

Remington Medical Inc. began a recall of Model 6149 Pacing Vector Selector Cable Switch for use with Pacing System Analyzers * Rx only * Contents Are Not Sterile * Manufactured by Remington Medical... on . The reason FDA records is "The vector selector has an electrical design flaw which prevents RV pacing". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0124-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Remington Medical
Product
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.
Product code
DTA Tester, Pacemaker Electrode Function
Reason for recall
The vector selector has an electrical design flaw which prevents RV pacing.
Root cause tag
design
FDA root cause
Other
Action
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.
Quantity in commerce
600 units
Distribution
MN
Product codes and lots
Lot number: 051781, 051782, 051783, 051788, 0517939.