Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0870-06

ESP 140 Syringe Pump. Used for medication infusion. Model 140A and 140D, manufactured by Excelsior Medical...

Excelsior Medical LLC / initiated 2006-03-21 / Terminated

Excelsior Medical Corp began a recall of ESP 140 Syringe Pump. Used for medication infusion. Model 140A and 140D, manufactured by Excelsior Medical Corporation, Neptune, NJ on . The reason FDA records is "Potential for alarm failure when the 140 pump completes infusion and/or the pump encounters a mid-infusion occlusion, when used in the 140 mode with a 140cc syringe. The ESP Pump works correctly when used in 60 mode...". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0870-06
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Excelsior Medical LLC
Product
ESP 140 Syringe Pump. Used for medication infusion. Model 140A and 140D, manufactured by Excelsior Medical Corporation, Neptune, NJ.
Product code
FRN Pump, Infusion
Reason for recall
Potential for alarm failure when the 140 pump completes infusion and/or the pump encounters a mid-infusion occlusion, when used in the 140 mode with a 140cc syringe. The ESP Pump works correctly when used in 60 mode with a 60cc syringe or smaller.
FDA root cause
Other
Action
An 'Urgent Recall' letter was mailed certified return receipt mail on 3/22/06 to all customers per distribution list.
Quantity in commerce
3911 units
Distribution
Nationwide and Quebec, Canada
Product codes and lots
All Serial Numbers since 1996.