Recall Z-1371-2008 ยท NEP System/Device, Pharmacy Compounding
Baxa Corporation
Exacta-Mix 600 Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients into on final solution based on user-specified sequences and volumes.
| Date | Aug 19, 2008 (initiated Feb 11, 2008) |
| Status | Terminated |
| Reason | Flush solution from TPN compounder may be added to patient's TPN bag. |
| Root cause | Software design |
| Action | Consignees were notified by letter (Exacta-Mix Compounder Software Safety Alert) on 02/11/2008 advising them of the necessity to install a waste bag prior to a machine flush. |
| Quantity | 221 units |
| Distribution | Nationwide, including military facilities in CA, FL, HI, MS, NC, TX, VA and VA facilities in NY, OR, SC, UT. Foreign distribution to Australia, Canada, China and New Zealand. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.