Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0981-05

Clinician Workstation Software, product code 2M5042

Baxter Healthcare Corporation / initiated 2005-03-10 / Terminated

Baxter Healthcare Corp. began a recall of Clinician Workstation Software, product code 2M5042 on . The reason FDA records is "The medication administration results displayed in the 'View Results' link may be inaccurate". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0981-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Baxter Healthcare Corporation
Product
Clinician Workstation Software, product code 2M5042
Product code
LNX
Reason for recall
The medication administration results displayed in the 'View Results' link may be inaccurate.
FDA root cause
Other
Action
Urgent Device Correction recall letters dated 3/10/05 were sent to the direct accounts on the same date via first class mail. The letter describes the inaccuracies in the 'View Results' program, and informed the accounts that inaccurate information could lead to incorrect clinical decision-making, which could impact a patient''s medication treatment protocol. The accounts were requested to disable the 'View Results' link until a software upgrade is available, and to inform all clinical point of care users that the 'View Results' has been disabled and that the Manual Adminstration Record is to be used as the primary source of information for reviewing medication adminstration results. The accounts were instructed to contact their account executive and/or the Client Support Services at 1-877-835-2727 for instructions on how to disable the 'View Results' feature.
Quantity in commerce
5 units
Distribution
Missouri, Massachusetts, Vermont, California and Canada.
Product codes and lots
Product code 2M5042, software versions 3.4, 4.0 and 4.1