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Terminated

Exacta-Mix 2400, Pharmacy Compounding System is used in the pharmacy to compound multiple source ingredients into on final solution based on user-specified sequences and volumes.

FDA Recall Z-1370-2008 · Posted 2008-08-19

Recalling FirmBaxa Corporation
Recall StatusTerminated
Product CodeNEP
Date Initiated2008-02-11
Date Terminated2012-03-16
Product Quantity1000 units

Reason for Recall

Flush solution from TPN compounder may be added to patient's TPN bag.

Firm Action

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

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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