Recall Z-0210-04 ยท NEP System/Device, Pharmacy Compounding
Baxa Corporation
Exacta-Mix 2400 pharmacy compounding system.
| Date | Jul 20, 2004 (initiated Nov 7, 2003) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002705 | EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 Baxa Corp., Mar 28, 2001 |