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
This recall has been terminated (originally issued April 9, 2012).
- Company
- Baxa Corporation
- Recall Initiated
- March 23, 2009
- Posted
- April 9, 2012
- Terminated
- April 10, 2012
- Recall Number
- Z-1389-2012
- Quantity
- 1322 units
- Firm Location
- Englewood, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Software issue with compounding pump resulting in over delivery of component ingredients during routine operations.
Distribution
Worldwide Distribution - USA Nationwide including Canada.
Lot / Code Info
2 model numbers 2400 D and 2400 M.
Root Cause
Software design
Action Taken
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.