Cl I Baxa Corporation

Company:Baxa Corporation, Inc
Date of Enforcement Report:10/3/2007
Class:l

PRODUCT
Exacta-Mix 2400 OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Recall # Z-1238-2007

REASON
A software defect could allow up to 50mL of extra volume being added to a TPN (Total Parenteral Nutrition) solution.

RECALLING FIRM/MANUFACTURER
Baxa Corporation, Englewood, CO, by telephone and letter on June 27, 2007. Firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
30 units

DISTRIBUTION
CA, CO, FL, DY, MI, NY, OH, OR, and TX

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.

Corporate Office

15148 Springview St
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN) and Italy.