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Terminated

Clinician Workstation Software, product code 2M5042

FDA Recall Z-0981-05 · Posted 2005-07-13

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeLNX
Date Initiated2005-03-10
Date Terminated2008-02-06
Product Quantity5 units

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

Missouri, Massachusetts, Vermont, California and Canada.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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