FDA Medical Device Recalls (openFDA)
Baxa Corporation: Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Englewood, CO 80112.
- Recall number
- Z-1238-2007
- Recalling firm
- Baxa Corporation
- Product
- Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Englewood, CO 80112.
- Status
- Terminated
- Initiated
- 2007-06-27
- Posted
- 2007-09-27
- Terminated
- 2007-12-07
- Reason
- A software defect could allow up to 50mL of extra volume being added to a TPN solution.
- Root cause
- Other
- Action
- 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.
- Quantity
- 30 units
- Distribution
- Class I Recall-Worldwide Distribution: USA including states of CA, CO, FL, KY, MI, NY, OH, OR, and TX and the UK
- Lot, serial or model codes
- 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)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- NEP
- Firm FEI
- 1419106
- Firm city
- Englewood
- Firm state
- CO
- 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