Exacta-Mix 2400 pharmacy compounding system.
FDA device recall Z-0210-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Baxa Corporation
- 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..
- Action taken
- All users were contacted by phone and fax on 11/7/03 with instructions to safely use the device.
- Root cause
- Other
- Status
- Terminated
- Product code
- NEP
- Quantity affected
- 231 systems
- Distribution
- Nationwide. Foreign distribution to UK. No government or military consignees.
- Date initiated
- 2003-11-07
- Date posted
- 2004-07-20
- Date terminated
- 2004-02-24
- Location
- Englewood, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXACTA-MIX 2400 COMPOUNDING SYSTEM, MODEL EXACTA-MIX 2400 (K002705) | Baxa Corp. | 2001-03-28 |