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U.S. Department of Health and Human Services

Class 2 Device Recall Nova Biomedical

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 Class 2 Device Recall Nova Biomedicalsee related information
Date Initiated by FirmMarch 30, 2004
Date PostedJuly 20, 2004
Recall Status1 Terminated 3 on June 17, 2004
Recall NumberZ-0827-04
Recall Event ID 28725
Product Classification Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph - Product Code CHL
ProductStat Profile Critical Care Xpress CCX+ Analyzer Catalog Number: 37413
Code Information Domestic Serial Numbers: Y02C03170 Y02C03140 Y02C03180 Y02104060 Y02104180 Y02104070 Y02104210 Y02104080 Y02204180  International S/N: Y02204030 Y02204040 Y02204050 Y02204110 Y02204120 Y02204140 Y02204190 Y02304020 Y02C03190 Y02C03160 Y02C03090 Y02204060 Y02C03070 Y02304050 Y02C03050 Y02104090 Y02104230 Y02104170 Y02104020 Y02304070 
FEI Number 1219029
Recalling Firm/
Manufacturer		 Nova Biomedical Corporation
200 Prospect St
Waltham MA 02453-3457
For Additional Information ContactPaul 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
ActionNova 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 Commerce30 units
DistributionCA, 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 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.
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