ClearanceBrief
Recall Z-0062-05 ยท FRN Pump, Infusion

Infusion Dynamics, A Div. of Zoll Med Corpinfusion Dynamics

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

DateNov 2, 2004 (initiated Sep 21, 2004)
StatusTerminated
ReasonFront 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.
Root causeOther
ActionThe 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.
Quantity255 units
DistributionThe 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.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K030739INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE
Infusion Dynamics, Inc., Jan 14, 2004
K992044INFUSION DYNAMICS POWER INFUSER MODEL M100B
Infusion Dynamics, Inc., Sep 8, 1999