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/ 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 |
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.
|