ClearanceBrief
Recall Z-1141-2007 ยท LZH Pump, Infusion, Enteral

Ross Products Division Abbott Laboratories

Embrace Enteral Pump

DateAug 8, 2007 (initiated Jun 21, 2007)
StatusTerminated
ReasonContinued use of the pump may cause the door pivot point on the back of the pump to crack or break. This will cause the pump to shut down and stop the initiation of enteral feeding.
Root causeEquipment maintenance
ActionConsignees were notified by letter dated 6/25/2007. The firm sent a revised letter on 07/26/2007.
Quantity9,600 units
DistributionThe product was distributed throughout the US.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K031407ROSS EMBRACE ENTERAL PUMP
Ross Product Div. Abbott Laboratories, May 20, 2003