FDA Medical Device Recalls (openFDA)
Baxa Corporation: Exacta-Mix 2400 pharmacy compounding system.
- Recall number
- Z-0210-04
- Recalling firm
- Baxa Corporation
- Product
- Exacta-Mix 2400 pharmacy compounding system.
- Status
- Terminated
- Initiated
- 2003-11-07
- Posted
- 2004-07-20
- Terminated
- 2004-02-24
- Reason
- If device stops due to an alarm or operater pause, inlet valves will remain open, allowing some unwanted mixing of ingredients in the valve chamber..
- Root cause
- Other
- Action
- All users were contacted by phone and fax on 11/7/03 with instructions to safely use the device.
- Quantity
- 231 systems
- Distribution
- Nationwide. Foreign distribution to UK. No government or military consignees.
- Lot, serial or model codes
- Catalog Number EM2400, all serial numbers.
- 510(k) numbers
- ["K002705"]
- 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