Baxter Healthcare Corp. Rt. Baxter''s Patient Care System (BPCS) software, Pharmacy Management - Inpatient - product code 2M5013 and Point of Care - product code 2M5014; Baxter Healthcare Corporation, 1 Baxter Parkway, Deerfield, IL 60015, USA, made in Canada Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

If an administrative user modifies any of the seven pre-defined Monitoring Parameters when they are attached to a medication in the drug file, a Point of Care end user will be unable to enter monitoring parameter results on the handheld.

Recommended Action

Per FDA guidance

Urgent Device Correction recall letters dated 8/29/05 were sent to the direct accounts on the same date via first class mail. The letter describes the issue with the modification or creation of a Monitoring Parameter, and informed the accounts that modifying the Monitoring Parameters could result in a potential for a patient receiving an incorrect medication or an incorrect medication dosage. The accounts were advised that administrative end users should never modify the seven pre-defined Monitoring Parameters or create new Monitoring Parameters.

Distribution

As reported by FDA

CA, MA, MO, VT