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U.S. Department of Health and Human Services

Class 1 Device Recall ExactaMix 2400

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 Class 1 Device Recall ExactaMix 2400see related information
Date Initiated by FirmJune 27, 2007
Date PostedSeptember 27, 2007
Recall Status1 Terminated 3 on December 07, 2007
Recall NumberZ-1238-2007
Recall Event ID 38372
Product Classification Pharmacy compounding system - Product Code NEP
ProductExacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Englewood, CO 80112.
Code Information 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)
Recalling Firm/
Manufacturer
Baxa Corporation
14445 Grasslands Dr
Englewood CO 80112-7062
For Additional Information Contact
303-617-2242
Manufacturer Reason
for Recall
A software defect could allow up to 50mL of extra volume being added to a TPN solution.
FDA Determined
Cause 2
Other
ActionAll 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.
Quantity in Commerce30 units
DistributionClass I Recall-Worldwide Distribution: USA including states of CA, CO, FL, KY, MI, NY, OH, OR, and TX and the UK
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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