FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: 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 number
- Z-0061-06
- Recalling firm
- Baxter Healthcare Corp.
- 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
- Status
- Terminated
- Initiated
- 2005-08-29
- Posted
- 2005-10-15
- Terminated
- 2008-02-06
- Reason
- 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.
- 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
- 5 units
- Distribution
- Missouri, Massachusetts, Vermont, California and Canada.
- Lot, serial or model codes
- all units of software versions 4.0 (66) and 4.1 (77)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LNX
- Firm FEI
- 1416980
- Firm city
- Round Lake
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28