Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0062-05

Infusion Dynamics Power Infuser pump. Model number M100B-3A

Infusion Dynamics, A Div. of Zoll Med Corpinfusion Dynamics began a recall of Infusion Dynamics Power Infuser pump. Model number M100B-3A on . The reason FDA records is "Front Panel may be cracked on some units. If cracked fluid can enter the infuser and short the start/stop button. Shorting would cause the infuser to stay in the open position". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0062-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Infusion Dynamics, A Div. of Zoll Med Corpinfusion Dynamics
Product
Infusion Dynamics Power Infuser pump. Model number M100B-3A
Product code
FRN Pump, Infusion
Reason for recall
Front Panel may be cracked on some units. If cracked fluid can enter the infuser and short the start/stop button. Shorting would cause the infuser to stay in the open position.
FDA root cause
Other
Action
The recalling firm issued a recall letter dated 9/20/04 to their customers informing them of the problem and the need to return the units.
Quantity in commerce
255 units
Distribution
The products were shipped to dealers in TX, MO, and VT; medical facilities in CA, NV, and NY. The product was also shipped to government accounts in PA and Germany.
Product codes and lots
Serial numbers 13-05863 through 13-05929 and 13-6005 through 13-06036