Recalls / —

—#37948

Product

Clinician Workstation Software, product code 2M5042

FDA product code

LNX

Affected lot / code info

Product code 2M5042, software versions 3.4, 4.0 and 4.1

Why it was recalled

The medication administration results displayed in the 'View Results' link may be inaccurate.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm

Baxter Healthcare Corp. Rt.

Address

120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern

Missouri, Massachusetts, Vermont, California and Canada.

Timeline

Recall initiated

2005-03-10

Posted by FDA

2005-07-13

Terminated

2008-02-06

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #37948. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.