04
Aug
2011

Cl ll LOGIX Order Entry (OE) Software

0

Company:Baxter Healthcare Corp.
Date of Enforcement Report 8/3/11
Class ll:

PRODUCT
LOGIX Order Entry (OE) Software, all versions, catalog 2M8410. The software is included in a number of Baxter’s pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration. Recall # Z-2291-2011.

REASON
The LOGIX OE automated backup does not retain the three most recent backup files and instead will only retain the last three backups of the previous year. The software stores backup files in numeric order rather than chronological date order.

RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letter dated March 29, 2011.

Manufacturer: Baxter Healthcare Corp., Buffalo Grove, IL. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
84 units

DISTRIBUTION
Nationwide, PR, and Canada

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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