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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 Biomedical see related information
Date Initiated by Firm March 30, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on June 17, 2004
Recall Number Z-0826-04
Recall Event ID 28725
510(K)Number K022746  
Product Classification Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph - Product Code CHL
Product Stat Profile Critical Care Xpress (CCX) Analyzer
Catalog Number: 35942
Code Information Domestic S/N: Y01C03200 Y01C03130 Y01104030 Y01104040 Y01104100 Y01104110 Y01304150 Y01304120 Y01104150 Y01104130 Y01104050 Y01104190 Y01104160 Y01104220 Y01204020 Y01204100 Y01204010 Y01204130 Y01204150 Y01204160 Y01703120 Y01304040 Y01304010 Y01304110  International S/N: Inst. S/N Y01204200 Y01304030 Y01304130 Y01304140 Y01304090 Y01304100 Y01104140 Y01204070 Y01204170 Y01104120 Y01C03150  
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 35 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
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 = CHL and Original Applicant = NOVA BIOMEDICAL CORP.
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