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.
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