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Terminated

Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Englewood, CO 80112.

FDA Recall Z-1238-2007 · Posted 2007-09-27

Recalling FirmBaxa Corporation
Recall StatusTerminated
Product CodeNEP
Date Initiated2007-06-27
Date Terminated2007-12-07
Product Quantity30 units

Reason for Recall

A software defect could allow up to 50mL of extra volume being added to a TPN solution.

Firm Action

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.

Root Cause

Other

Distribution Pattern

Class I Recall-Worldwide Distribution: USA including states of CA, CO, FL, KY, MI, NY, OH, OR, and TX and the UK

Official Source

View FDA Recall →

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

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