| Class 1 Device Recall ExactaMix 2400 | |
Date Initiated by Firm | June 27, 2007 |
Date Posted | September 27, 2007 |
Recall Status1 |
Terminated 3 on December 07, 2007 |
Recall Number | Z-1238-2007 |
Recall Event ID |
38372 |
Product Classification |
Pharmacy compounding system - Product Code NEP
|
Product | Exacta-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 |
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. |
Quantity in Commerce | 30 units |
Distribution | Class I Recall-Worldwide Distribution: USA including states of CA, CO, FL, KY, MI, NY, OH, OR, and TX and the UK |
Total Product Life Cycle | TPLC Device Report |
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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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