ClearanceBrief
Recall Z-0568-05 ยท FRN Pump, Infusion

Alaris Medical Systems Inc

Model 8100 Series Medley Medication Safety System Pump Module

DateMar 3, 2005 (initiated Nov 10, 2004)
StatusTerminated
ReasonThe device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module. To date there have been complaints from three (3) different customer locations.
Root causeOther
ActionA device modification is being implemented in response to information received from the field regarding a specific method of misloading the medication administration tubing set into the infusion system pump module.
Quantity55,200
DistributionUnited States and Canada
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K012383GEMINI PC-1,PC-2, PC-2TX,PC-4, SIGNATURE EDITION INFUSION PUMP (SE), MEDSYSTEM III INFUSION (MSIII), MEDSYSTEM PATIENT C
Alaris Medical Systems, Inc., Oct 2, 2001
K950419THE IMED ORION INFUSION PUMP AND ADMINISTRATION SETS
Imed Corp., Jun 21, 1995