Exacta-Mix 2400 pharmacy compounding system.
FDA Recall Z-0210-04 · Posted 2004-07-20
Recalling FirmBaxa Corporation
Recall StatusTerminated
Product CodeNEP
Date Initiated2003-11-07
Date Terminated2004-02-24
Product Quantity231 systems
Reason for Recall
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..
Firm Action
All users were contacted by phone and fax on 11/7/03 with instructions to safely use the device.
Root Cause
Other
Distribution Pattern
Nationwide. Foreign distribution to UK. No government or military consignees.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.