Recall Z-1389-2012 ยท NEP System/Device, Pharmacy Compounding
Baxa Corporation
Pharmacy compounding system . It is a twenty-four source compounder for multi-source fluid mixing of both macro and micro ingredient down to 0.2 ml quantities. Product Usage: Pharmacy compounding System for parenteral macro and micro ingredients
| Date | Apr 9, 2012 (initiated Mar 23, 2009) |
| Status | Terminated |
| Reason | Software issue with compounding pump resulting in over delivery of component ingredients during routine operations. |
| Root cause | Software design |
| Action | Baxa sent a Safety Alert letter dated March 23, 2009 to all affected consignees. The letter identified the affected product, problem and recommended actions with specific instructions related to the issue. Additionally, the firm will be providing a warning label for the affected product as soon as possible and is currently working on a product upgrade to correct the issue. For assistance contact Baxa Technical Support at 800-678-2292. The firm is also providing a 24 hour a day, 7 days a week Technical Support for the affected product. |
| Quantity | 1322 units |
| Distribution | Worldwide Distribution - USA Nationwide including Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.