Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Englewood, CO 80112.
This recall has been terminated (originally issued September 27, 2007).
- Company
- Baxa Corporation
- Recall Initiated
- June 27, 2007
- Posted
- September 27, 2007
- Terminated
- December 7, 2007
- Recall Number
- Z-1238-2007
- Quantity
- 30 units
- Firm Location
- Englewood, CO
- Official Source
- View on FDA website ↗
Reason for Recall
A software defect could allow up to 50mL of extra volume being added to a TPN solution.
Distribution
Class I Recall-Worldwide Distribution: USA including states of CA, CO, FL, KY, MI, NY, OH, OR, and TX and the UK
Lot / Code Info
Version 1.07 of the EM2400 Operating Software. (Serial Numbers: 36805,36806,36356,36399,36804,36799,36797,36398,32438,36798,36460,36794,32346,36800,36801,36802,36803,(37767-36773), (36788-36793),36795 and 36796 (foreign)
Root Cause
Other
Action Taken
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.