ClearanceBrief
Recall Z-1142-2007 ยท LZH Pump, Infusion, Enteral

Ross Products Division Abbott Laboratories

The Companion ClearStar Pump System, for enteral feeding.

DateAug 7, 2007 (initiated Jun 21, 2007)
StatusTerminated
ReasonThe transducer adapter bracket on the pump could crack or break and potentially result in under delivery of the enteral product.
Root causeEquipment maintenance
ActionConsignees were notified by letter dated 6/25/2007. A revised letter was sent 07/26/2007.
Quantity27,814
DistributionWorldwide, including USA and Canada.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K981541CLEARSTAR ENTERAL NUTRITION PUMP
Frantz Medical Development, Ltd., Aug 13, 1998