Exacta-Mix 2400, Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients into on fin
FDA device recall Z-1370-2008 · posted 2008-08-19 · Terminated
Recall details
- Recalling firm
- Baxa Corporation
- Reason for recall
- Flush solution from TPN compounder may be added to patient's TPN bag.
- Action taken
- 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.
- Root cause
- Software design
- Status
- Terminated
- Product code
- NEP
- Quantity affected
- 1000 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.
- Date initiated
- 2008-02-11
- Date posted
- 2008-08-19
- Date terminated
- 2012-03-16
- Location
- Englewood, CO
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