Z-0061-06

Baxter''s Patient Care System (BPCS) software, Pharmacy Management - Inpatient - product code 2M5013 and...

Name: Z-0061-06 Baxter''s Patient Care System (BPCS) software, Pharmacy Management - Inpatient - product code 2M5013 and...
Creator: Baxter Healthcare Corp.
Published: 2005-08-29
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2005-08-29 / Terminated

FDA source

Baxter Healthcare Corp. began a recall of Baxter''s Patient Care System (BPCS) software, Pharmacy Management - Inpatient - product code 2M5013 and Point of Care - product code 2M5014; Baxter Healthcare... on 2005-08-29. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0061-06
Status: Terminated
Initiated: 2005-08-29
Posted: 2005-10-15
Terminated: 2008-02-06
Recalling firm: Baxter Healthcare Corporation
Product: 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
Product code: LNX
Reason for recall: 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.
FDA root cause: Other
Action: 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.
Quantity in commerce: 5 units
Distribution: Missouri, Massachusetts, Vermont, California and Canada.
Product codes and lots: all units of software versions 4.0 (66) and 4.1 (77)

Product code LNX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)