| Date Initiated by Firm | November 07, 2003 |
|---|
| Date Posted | July 20, 2004 |
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| 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.. |
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FDA Determined
Cause 2 | Other |
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| Action | All users were contacted by phone and fax on 11/7/03 with instructions to safely use the device. |
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| Quantity in Commerce | 231 systems |
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| Distribution | Nationwide. Foreign distribution to UK. No government or military consignees. |
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| 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
|
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