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U.S. Department of Health and Human Services

Class 2 Device Recall Pharmacy Compounding System

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  Class 2 Device Recall Pharmacy Compounding System see related information
Date Initiated by Firm November 07, 2003
Date Posted July 20, 2004
Recall Status1 Terminated 3 on February 24, 2004
Recall Number Z-0210-04
Recall Event ID 27695
510(K)Number k002705  
Product Classification System/Device, Pharmacy Compounding - Product Code NEP
Product Exacta-Mix 2400 pharmacy compounding system.
Code Information Catalog Number EM2400, all serial numbers.
Recalling Firm/
Baxa Corporation
14445 Grasslands Dr
Englewood CO 80112-7062
For Additional Information Contact
Manufacturer Reason
for Recall
If device stops due to an alarm or operater pause, inlet valves will remain open, allowing some unwanted mixing of ingredients in the valve chamber..
FDA Determined
Cause 2
Action All users were contacted by phone and fax on 11/7/03 with instructions to safely use the device.
Quantity in Commerce 231 systems
Distribution Nationwide. Foreign distribution to UK. No government or military consignees.
Total Product Life Cycle TPLC 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.
510(K) Database 510(K)s with Product Code = NEP and Original Applicant = BAXA CORP.