Class 2 Device Recall Nova Biomedical

• Date Initiated by Firm: March 30, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated 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: 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

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.