Baxa Corporation Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Englewood, CO 80112. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Englewood, CO 80112.
Brand
Baxa Corporation
Lot Codes / Batch Numbers
Version 1.07 of the EM2400 Operating Software. (Serial Numbers: 36805, 36806, 36356, 36399, 36804, 36799, 36797, 36398, 32438, 36798, 36460, 36794, 32346, 36800, 36801, 36802, 36803, (37767-36773), (36788-36793), 36795 and 36796 (foreign)
Products Sold
Version 1.07 of the EM2400 Operating Software. (Serial Numbers: 36805,36806,36356,36399,36804,36799,36797,36398,32438,36798,36460,36794,32346,36800,36801,36802,36803,(37767-36773), (36788-36793),36795 and 36796 (foreign)
Baxa Corporation is recalling Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Engle due to A software defect could allow up to 50mL of extra volume being added to a TPN solution.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
A software defect could allow up to 50mL of extra volume being added to a TPN solution.
Recommended Action
Per FDA guidance
All customers were notified via telephone on 06/27/2007 with follow-up of a faxed/emailed Urgent Product Recall letter dated 27 June 2007, detailing the software defect. End users were given a work around procedure to use until conversion back to version 1.06 could be scheduled. An additional copy of the recall letter was sent by FedEx.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
CA, CO, FL, KY, MI, NY, OH, OR, TX
Page updated: Jan 10, 2026