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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 Systemsee related information
Date Initiated by FirmNovember 07, 2003
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on February 24, 2004
Recall NumberZ-0210-04
Recall Event ID 27695
510(K)NumberK002705 
Product Classification System/Device, Pharmacy Compounding - Product Code NEP
ProductExacta-Mix 2400 pharmacy compounding system.
Code Information Catalog Number EM2400, all serial numbers.
Recalling Firm/
Manufacturer
Baxa Corporation
14445 Grasslands Dr
Englewood CO 80112-7062
For Additional Information Contact
303-617-2181
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
Other
ActionAll users were contacted by phone and fax on 11/7/03 with instructions to safely use the device.
Quantity in Commerce231 systems
DistributionNationwide. Foreign distribution to UK. No government or military consignees.
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.
510(K) Database510(K)s with Product Code = NEP
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