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Class 2 Device Recall Nova Biomedical |
 |
| Date Initiated by Firm |
March 30, 2004 |
| Date Posted |
July 20, 2004 |
| Recall Status1 |
Terminated 3 on June 17, 2004 |
| Recall Number |
Z-0828-04 |
| Recall Event ID |
28725 |
| Product Classification |
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph - Product Code CHL
|
| Product |
Stat Profile Critical Care Xpress CCX (R) Analyzer
Catalog Number: 37562
R= Refurbished |
| Code Information |
Serial Numbers: Inst. S/N Y01902211 Y01203021 Y01B02101 |
Recalling Firm/
Manufacturer |
Nova Biomedical Corporation
200 Prospect St
Waltham MA 02453-3457
|
| For Additional Information Contact |
Paul MacDonald
781-647-3700 Ext. 211
|
Manufacturer Reason
for Recall |
Incorrectly assembled pumps may result in inconsistent compression of the tubing causing erratic results or calibration problems
|
FDA Determined
Cause 2 |
Other |
| Action |
Nova Biomedical notified users by telephone on 3/31/04 and conducted follow-up by letter either by email or fax. On-site visit will be scheduled to replace the pump assembly. |
| Quantity in Commerce |
3 units |
| Distribution |
CA, IL, LA, MA ,NJ, NY, OH, PA, TX
International: Italy ,England, Japan,Turkey., U.A.E., Greece, Thailand, Switzerland, Finland, Saudi Arabia, Italy, Mexico, Trinidad, Ireland, France, Cyprus, Czech Republic, ,Germany |
| 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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