Recall Z-1238-2007 ยท NEP System/Device, Pharmacy Compounding
Baxa Corporation
Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Englewood, CO 80112.
| Date | Sep 27, 2007 (initiated Jun 27, 2007) |
| Status | Terminated |
| Reason | A software defect could allow up to 50mL of extra volume being added to a TPN solution. |
| Root cause | Other |
| Action | All customers were notified via telephone on 06/27/2007 with follow-up of a faxed/emailed Urgent Product Recall letter dated 27 June 2007, detailing the software defect. End users were given a work around procedure to use until conversion back to version 1.06 could be scheduled. An additional copy of the recall letter was sent by FedEx. |
| Quantity | 30 units |
| Distribution | Class I Recall-Worldwide Distribution: USA including states of CA, CO, FL, KY, MI, NY, OH, OR, and TX and the UK |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.